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Documents 1-25 out of 118 found
  Current Search:  cardura: 140, doxazosin: 298, mesylate: 1347  
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Teva Pharmaceutical Industries - News and PR
- - Search Tevapharm: - - Press Release Teva Received Final Approval for Doxazosin Mesylate TO BE SHIPPED IMMEDIATELY Jerusalem, Israel, October 22, 2000 - Teva Pharmaceutical Industries Ltd.
FDA final approval to manufacture and market Doxazosin Mesylate 1, 2, 4 and 8 mg Tablets.
Doxazosin Mesylate is the generic version of Pfizer’s...
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Paragraph IV Patent Certifications
- DRUG NAME DOSAGE FORM STRENGTH RLD Acetaminophen Extended-release Tablets 650 mg Tylenol Acetaminophen/ Aspirin/ Caffeine Tablets 250 mg/250 mg/ 65 mg Excedrin (migraine) Acetaminophen and Tramadol Hydrochloride Tablets 325 mg/ 37.5 mg Ultracet Acyclovir Sodium1 Injection 50 mg/mL, 10 mL and 20 mL vials Zovirax Albuterol Sulfate Oral Syrup 2 mg(base)/ 5 mL Ventolin Albuterol...
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http://www.fda.gov/cder/orange/appendix_a.txt
3, ACETAMINOPHEN ACETAMINOPHEN W/ CODEINE PHOSPHATE #3, ACETAMINOPHEN ACETAMINOPHEN W/ CODEINE PHOSPHATE, ACETAMINOPHEN ACETAMINOPHEN W/ CODEINE, ACETAMINOPHEN ACETAMINOPHEN, ACETAMINOPHEN (OTC) ACETAMINOPHEN, ASPIRIN AND CAFFEINE, ACETAMINOPHEN (OTC) ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE, ACETAMINOPHEN ACETAMINOPHEN, BUTALBITAL AND CAFFEINE, ACETAMINOPHEN ACETAMINOPHEN,...

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FDA Drug Approvals List February 2002
- Drug Approvals for February 2002 Definitions and Notes Original New Drug Applications Original Application #: 020982 Approval Date: 12-FEB-02 Trade Name: PAXIL CR Chemical Type: 6 Therapeutic Potential: S Dosage Form: TABLET Applicant: SMITHKLINE BEECHAM PHARMACEUTICALS Active Ingredient(s): PAROXETINE HYDROCHLORIDE OTC/RX Status: RX Indication(s): For the treatment of Panic...
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ANDA 75-353
ANDA 75- 353 January 12, 2001 Teva Pharmaceuticals USA Attention: Philip Erickson 1090 Horsham Road P
Box 1090 North Wales, PA 19454 Dear Sir: This is in reference to your abbreviated new drug application dated March 31, 1998, submitted pursuant to Section 505( j) of the Federal Food, Drug, and Cosmetic Act (Act), for Doxazosin Mesylate Tablets, 1 mg (base), 2 mg (base...

author: CDER User
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ANDA 75-353 page 1


author: CDER User
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http://www.fda.gov/cder/foi/appletter/2001/75750ltr.pdf page 1


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PRESCRIPTION DRUG PRODUCT LIST 17TH EDITION RX DRUG PRODUCT LIST
Prescription and Over-the-Counter Drug Product List - 17th Edition Cumulative Supplement Number 3: Feb '97 - Mar '97 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST - - ADD - AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; - ADD - AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; - ADD - POTASSIUM PHOSPHATE, DIBASIC; SODIUM...
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FDA Drug Approvals List October 2000
- Drug Approvals for October 2000 Definitions and Notes Original New Drug Applications Original Application #: 020958 Approval Date: 16-OCT-00 Trade Name: PEPCID COMPLETE Chemical Type: 4 Therapeutic Potential: S Dosage Form: TABLET, CHEWABLE Applicant: MERCK RESEARCH LABORATORIES DIV MERCK CO INC Active Ingredient(s): CALCIUM CARBONATE, PRECIPITATED; FAMOTIDINE; MAGNESIUM HYDROXIDE...
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http://www.fda.gov/cder/foi/appletter/2000/75580ltr.pdf
ANDA 75- 580 October 18, 2000 Apotex Corp
Agent for TorPharm 50 Lakeview Parkway, Suite #127 Vernon Hills, IL 60061 Dear Madam: This is in reference to your abbreviated new drug application dated February 10, 1999, submitted pursuant to Section 505( j) of the Federal Food, Drug, and Cosmetic Act (Act), for Doxazosin Mesylate Tablets, 1 mg (base), 2 mg (base), 4 mg ...

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http://www.fda.gov/cder/foi/appletter/2000/75580ltr.pdf page 1


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http://www.fda.gov/cder/foi/appletter/2000/75536ta.pdf
ANDA 75- 536 July 24, 2000 Teva Pharmaceuticals USA Attention: Deborah A
Agent for: Novopharm Limited 1510 Delp Drive Kulpsville, PA 19443 Dear Madam: This is in reference to your abbreviated new drug application dated December 24, 1998, submitted pursuant to Section 505( j) of the Federal Food, Drug, and Cosmetic Act (Act), for Doxazosin Mesylate Tablets, 1 mg (base),...

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http://www.fda.gov/cder/foi/appletter/2000/75536ta.pdf page 1


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http://www.fda.gov/cder/foi/appletter/2000/75536ltr.pdf
ANDA 75- 536 October 18, 2000 TEVA Pharmaceuticals USA Attention: Deborah A
Box 1090 North Wales, PA 19454- 1090 Dear Madam: This is in reference to your abbreviated new drug application dated December 24, 1998, submitted pursuant to Section 505( j) of the Federal Food, Drug, and Cosmetic Act (Act), for Doxazosin Mesylate Tablets, 1 mg (base), 2 mg (base), 4 mg (base),...

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http://www.fda.gov/cder/foi/appletter/2000/75536ltr.pdf page 1


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http://www.fda.gov/cder/foi/appletter/2000/75509ltr.pdf page 1


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http://www.fda.gov/cder/foi/appletter/2000/75466ltr.pdf
ANDA 75- 466 October 18, 2000 King and Spalding Attention: Eugene Pfeifer U
1730 Pennsylvania Avenue, NW Washington, DC 20006- 4706 Dear Sir: This is in reference to your abbreviated new drug application dated September 22, 1998, submitted pursuant to Section 505( j) of the Federal Food, Drug, and Cosmetic Act (Act), for Doxazosin Mesylate Tablets, 1 mg (base), 2 mg ...

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http://www.fda.gov/cder/foi/appletter/2000/75466ltr.pdf page 1


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http://www.fda.gov/cder/foi/appletter/2000/75453TA.pdf
ANDA 75- 453 July 26, 2000 Zenith Goldline Pharmaceuticals Inc
Attention: Patricia Jaworski 140 Legrand Ave Northvale, NJ 07647 Dear Madam: This is in reference to your abbreviated new drug application dated August 28, 1998, submitted pursuant to Section 505( j) of the Federal Food, Drug, and Cosmetic Act (Act), for Doxazosin Mesylate Tablets, 1 mg (base), 2 mg (base),...

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http://www.fda.gov/cder/foi/appletter/2000/75453TA.pdf page 1


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http://www.fda.gov/cder/foi/appletter/2000/75426ltr.pdf page 1


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News & PR - TEVA Pharmaceutical Industries Ltd
TEVA RECEIVED FINAL APPROVAL FOR DOXAZOSIN MESYLATE TO BE SHIPPED IMMEDIATELY Jerusalem, Israel, October 22, 2000 - Teva Pharmaceutical Industries Ltd
(Nasdaq: TEVA) announced today that it has received from the U.S
FDA final approval to manufacture and market Doxazosin Mesylate 1, 2, 4 and 8 mg Tablets
Doxazosin Mesylate is the generic...
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http://www.fda.gov/cder/foi/appletter/1999/75574ta.pdf
ANDA 75- 574 October 28, 1999 Purepac Pharmaceutical Co
Attention: Joan Janulis 200 Elmora Avenue Elizabeth, NJ 07207 Dear Madam: This is in reference to your abbreviated new drug application dated February 1, 1999, submitted pursuant to Section 505( j) of the Federal Food, Drug, and Cosmetic Act (Act), for Doxazosin Mesylate Tablets, 1 mg (base), 2 mg (base), 4 mg ...

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http://www.fda.gov/cder/foi/appletter/1999/75574ta.pdf page 1


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http://www.fda.gov/cder/foi/appletter/1999/75490ta.pdf page 1


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