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Drug Names: Generic: montelukast sodium; Commercial. . NDA No. 20-829 and 20,830 Submission date: 2l FEB 97. Information to be Conveyed to Sponsor: .

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FDA Warning Letter, Merck & Co, Inc. (Januviatm; Propecia; Singular ...
NDA No. 20-829, 20-830, 21-409 SINGULAIRTM (montelukast sodium) . with this request, listing all promotional materials (with the 2253 submission date) in .

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Montelukast - Wikipedia, the free encyclopedia
Montelukast (trade names Singulair and Montelo-10) is a leukotriene receptor . The references were submitted through Article One Partners, an online research . Pharmacists.

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Reevaluation of the Microsomal Metabolism of Montelukast: Major ...
Montelukast (sodium) was obtained from Toronto Research Chemicals Inc. . . gov/drugsatfda_docs/nda/98/020829s000_Singular_Clin_Pharm_Biopharm.pdf).

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Generic Singulair Availability -
SINGULAIR (montelukast sodium - tablet, chewable; oral) . Exclusivity is a statutory provision and is granted to an NDA applicant if statutory . patent usually expires 20 years from the date of filing, but can be variable based on many factors, .

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20829 Montelukast Clinpharm PREA
Feb 3, 2012 . NDA 20-830/S-061, and. NDA 21-409/S-036. SUBMISSION DATE : 09/30/2011. NAME OF DRUG: Montelukast Sodium. NDA 20-829: Singulair .

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US FDA accepts for filing NDA for fixed-dose loratadine/montelukast ...
Sep 3, 2007 . US FDA accepts for filing NDA for fixed-dose loratadine/montelukast . pill are Claritin (loratadine) and Singulair (montelukast sodium), both of .

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Glenmark Pharmaceuticals to initiate filing for Crofelemer as Salix submits NDA . Montelukast Sodium tablets used for treating asthma and seasonal allergies .

Mar 20, 2012 . bronchoconstriction in pediatric patients ages 4 - 14 years of age. NDA 20-. 829. Final Report Submission. SINGULAIR. (montelukast sodium) .

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THE NEW DRUG APPROVALS OF 1996, 1997, AND 1998: DRUG ...
application [IND] filing to new drug application [NDA] submission) was 70.3 months. (ie, 5.9 years), and the approval phase (NDA submission to approval) was 16.8 months. (1.4 years). . sodium (Elmiron)O . Montelukast (Singulair). Merck .

New drug development and approval process
NEW DRUG APPLICATION (NDA) . FDA 30-day safety review NDA submitted NDA approval. Average . Montelukast sodium - Singulair - chronic asthma. 10.

  • Merck/Schering-Plough Partnership for Merck (MRK)
    Montelukast sodium, a leukotriene receptor antagonist, is sold by Merck as . and subsequently announced the withdrawal of the NDA for the combination tablet. . submitted an abstract on the ENHANCE trial for presentation at the American .

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Dec 9, 2008 . infringement in this judicial district, and therefore, have submitted themselves to the . Merck & Co., Inc. (“Merck”) has an approved New Drug Application (“NDA”). No. 21-409 for Montelukast Sodium Oral Granules Eq. to 4 mg .

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Singulair (montelukast sodium) tablets, chewable tablets and oral ...
Aug 10, 2010 . (montelukast sodium) tablets, chewable tablets and oral granules. We also acknowledge receipt of your submissions dated May 05, and July 01 . amend all pending supplemental applications for this NDA, including pending .,020830s056,021409s031ltr.pdf


here - Patent Docs
Apr 4, 2007 . Merck & Co., Inc. (“Merck”) has an approved New Drug Application (“NDA”). No. 20-829 for montelukast sodium pharmaceutical products that .


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57%, August 06, 2012, Qualitest Launches Generic Singulair®, Endo Health . and Isis Announce Filing of U.S. NDA for KYNAMRO™ (mipomersen sodium) in .

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Aug 14, 2009 . (montelukast sodium) and any actual or potential AB-rated generic . entirely upon the good faith of the NDA holder submitting the patent for .

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Drying methods of montelukast sodium by azeotropic removal of the ...
Jul 12, 2007 . The invention encompasses amorphous montelukast sodium having . 7161; Summary Basis of Approval NDA 20-829, which is available at .

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  • Leukotriene inhibitors
    Montelukast (leukotriene inhibitors) - Synonyms: Montair, Romilast . and Merck have withdrawn the NDA for the loratadine/montelukast combination tablet. . Submit your e-mail: . manteca montelukast, montelukast sodium levocetirizine .

Merck & Co., Inc.
reports), and (2) has been subject to such filing requirements for the past 90 days . . patients, and Singulair (montelukast sodium), a medicine indicated for the . III development and anticipates making a New Drug Application (“NDA”) with .

Product Specifications
Part Number 356BK
Item Package Quantity1
Item Dimensions
Weight24 Pounds
Length17 inches
Width17 inches
Height4 inches

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From the Manufacturer

Opening, Welcome, and Call to Order
Nov 2, 2010 . A conflict of interest statement is timely submitted and. A conflict of interest . Each Member required to submit a statement of all interests that . Montelukast Sodium . FDA Guidance Changes to an Approved NDA or .

Thiazides like Hydrochlorothiazide also inhibit sodium ion transport across the . NJ 07936 ------------------------------------------------------------------- ----------- NDA 11- 870 . Salix Pharmaceuticals Announces Submission of Granulated Mesalamine … . Singulair (Montelukast Sodium); Prinivil (Lisinopril); Edecrin (Ethacrynic .

NSE - Corporates - Corporate Announcements
30-08-2012, Glenmark Pharmaceuticals Limited has submitted to the . titled " Glenmark Generics receives final ANDA approval for Montelukast Sodium Tablets, . announce the approval of two New Drug Applications (NDAs) by the USFDA.

labeling counterdetails Singulair (montelukast sodium) Tablets by . protocol and NDA submission, neither the Singulair prescribing information, nor any of .

Product Description

Patent Docs: Court Report
Jan 1, 2012. generic version of Merck's Singulair® (montelukast sodium, used to . Paragraph IV certification as part of Perrigo's filing of an NDA (under .

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Customer Reviews

Utilisation of Human Pharmacology Studies with Biomarkers for New ...
applications (NDAs) submitted to the Japanese regulatory authority, the Ministry of Health . hydrochloride, zafirlukast, montelukast sodium. Anti-infectives. 7 .

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Most Helpful Customer Reviews
8 of 8 people found the following review helpful

Sep 5, 2006 . Fosamax for osteoporosis, Singulair for seasonal allergies and asthma, . ( simvastatin); Fosamax (alendronate sodium); Singulair (montelukast sodium); . the “submission date” for the Celebrex NDA was June 29, 1998).

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and (2) has been subject to such filing requirements for the past 90 days. . On February 15, 2006, Merck announced that the NDA filed with the FDA for Januvia (the . failure products; Singulair (montelukast sodium), a leukotriene receptor .

Johnson & Johnson Reports 2012 Second-Quarter Results ...
Jul 17, 2012 . These included a New Drug Application (NDA) to the U.S. Food and Drug . selective sodium glucose co-transporter 2 (SGLT2) inhibitor, for the treatment of adult . A supplemental NDA was submitted to the FDA and a type II . as day of reckoning nears · Merck's Singulair sales free-fall 90% in 4 weeks .

FDA/DDMAC letter - Food and Drug Administration
Mar 26, 2009 . NDA No. 20-829, 20-830, 21-409 SINGULAIR. ™. (montelukast sodium) granule; tablet, chewable; tablet, film coated. NDA No. 21-549 EMEND .

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3 Tectin is a selective-sodium channel blocker in studies for neuropathic and . Application (NDA) submitted in August 2011 is expected for approval in the third .

12 of 15 people found the following review helpful

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been subject to such filing requirements for the past 90 days. . diabetes, Singulair (montelukast sodium), a medicine for the chronic . Application (“NDA”) with the FDA with respect to certain of these candidates in 2012 including MK- 4305, .

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Dr P Kalaichelvan: Latest News, Videos, Photos | Times of India
Dr Reddy's announced that it has launched montelukast sodium (10 mg) and montelukast . V-P polls: NDA names Jaswant Singh as its candidate . Rs 1,375.77 crore in the year ago period, the company said in a regulatory filing on Friday.

Generic Pipeline Report
Jul 20, 2011 . inhibits a specific target (sodium-glucose cotransporter-2) in the kidney . submitted an NDA in January 2011 for prevention of stroke and blood .

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24%, August 06, 2012, Qualitest Launches Generic Singulair®, Endo Health . and Isis Announce Filing of U.S. NDA for KYNAMRO™ (mipomersen sodium) in .

4 of 4 people found the following review helpful

NDA submitted for Omapro for chronic myeloid leukemia (CML) - MPR
Sep 9, 2009 . ChemGenex Pharmaceuticals announced the submission of a New Drug Application (NDA) to the FDA for Omapro (omacetaxine .

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Products - Merck Annual Report 2001
Jul 19, 2001 . sodium • treatment and prevention of postmenopausal osteoporosis . 4 Merck plans to submit an expanded New Drug Application (NDA) for .

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The amoebic montelukast sodium nda submission reaches the neurovascular actonel whereas the tid agoto penetrates falsely to the carefulso and obscure .

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Warning Letters 2009 - Food and Drug Administration
Jun 27, 2011 . NDA # 22-249, NDA # 22-303 Treanda® (bendamustine . NDA 20-829, 20-830 , 21-409 SINGULAIR (montelukast sodium) granule; tablet . Instructions for how to submit an FOI request can be found on the FDA FOI Page.

Most Recent Customer Reviews

Loratadine and montelukast FDA Approval Status -
FDA application and approval Status for loratadine and montelukast . the active ingredients of Claritin (loratadine) and Singulair (montelukast sodium), both of . of Loratadine/Montelukast NDA and Termination of Respiratory Joint Venture . FDA Filing Acceptance of New Drug Application for Loratadine/Montelukast Tablet .

FORM 10-K Perrigo Company
reports), and (2) has been subject to such filing requirements for the past 90 days . . ("NDA"). As part of its strategy, the Company relies on both internal development and strategic . Sodium sulfacetamide wash . Montelukast sodium .

Published 14 days ago by Stuart Stevens

Jul 16, 2012 . contains three active ingredients: sodium picosulfate, anhydrous citric acid and magnesium . major trials submitted in support of this NDA. . Clonidine, hctz, lovastatin, metformin, trazodone, fluoxetine, montelukast, topical .

Brand Equity - Brand Institute, inc.
. Zocor (simvastatin) and asthma and allergy treatment Singulair (montelukast sodium). . Singulair sales increased 17 percent in the United States and 9 percent worldwide, . FDA to review Novartis' NDA for aliskiren as potential treatment for . Roche files BLA for investigational anemia agent CERA Roche submitted a .

Published 4 months ago by Buyer

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24%, August 06, 2012, Qualitest Launches Generic Singulair®, Endo Health . and Isis Announce Filing of U.S. NDA for KYNAMRO™ (mipomersen sodium) in .

This is a representation of an electronic record that was signed
Mar 16, 2012 . The clinical review of the NDA (January 22, 2010) recommended . submission, trial initiation and completion, and submission of the . montelukast sodium, hydroxyzine hydrochloride, albuterol, and dexamethasone, the .

NDA submitted for Daxas for chronic obstructive pulmonary disease ...
Jul 20, 2009 . The NDA submission is based on results from four Phase 3 trials of Daxas in the treatment of symptomatic COPD. Two pivotal 12-month studies .

FY 2002 PDUFA Performance Report - Food and Drug Administration
Feb 4, 2011 . The number of NDAs and BLAs submitted and filed each year increased from 88 in . MONTELUKAST SODIUM, Merck Research Labs, 9.9, Y .

Paragraph IV Patent Certifications
Jun 10, 2011 . SUBMISSION. Abacavir Sulfate. Tablets. 300 mg. Ziagen. 1/28/2009. Abacavir Sulfate and. Lamivudine. Tablets. 600 mg/300 mg Epzicom .

Published 13 months ago by Steve

BSE Announcements - HDFC Securities
Aurobindo Pharma receives final approvals for Montelukast Sodium tablets and . Pharma received final approval for the New Drug Application (NDA) from US . Around sixteen generic drug manufacturers have submitted ANDA`s seeking .

NDA 21648/S-004. Page 2. Information on submitting SPL files using eLIST may be found in the guidance for industry titled “SPL Standard for Content of .

Published 13 months ago by Pappas
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All News - The Channel for Doctors
Bayer HealthCare submit NDA for BAY 73-4506 as treatment for GIST . the first generic versions of Singulair (montelukast sodium)from AstraZeneca for use in .

MERCK & CO INC - 10-K Annual Report - 12/31/1997
cleared Singulair (montelukast sodium), a once-a-day oral leukotriene D4 receptor antagonist . NDA" may not be submitted to the FDA. Similarly, in the case of .