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Documents 1-25 out of 158 found
  Current Search:  betapace: 186, sotalol: 574, hydrochloride: 3359  
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Drug Approvals - B
- ANDA 76-476 2/11/04 2/12/04 - - Benazepril Hydrochloride Tablets, 5, 10, 20 & 40 mg, Rx Andrx Pharmaceuticals ANDA 76-267 2/11/04 2/12/04 - - Benazepril Hydrochloride Tablets, 5, 10, 20 & 40 mg, Rx Tentatively Approved Andrx Pharmaceuticals ANDA 76-267 2/26/03 - - - Benazepril Hydrochloride Tablets, 5, 10, 20 & 40 mg, Rx Teva Pharmaceuticals ANDA 76-211 2/11/04 2...
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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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../2001/19-865S010_Betapace_
Food and Drug Administration • Center for Drug Evaluation and Research Title Search Betapace (Sotalol Hydrochloride) Tablets Company:--Berlex Application No.:--19-865/S10 Approval Date:-10/1/2001 Approval Letter(s) - Printed Labeling - Medical Review(s) - Pharmacology Review(s) - Clinical Pharmacology Biopharmaceutics Review(s) - Administrative Document(s) -...
author: USERNAME
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Prescription and Over-the-Counter Drug Product List: 8/2003
4MG/HR N74607 001 AUG 30, 1996 AUG CRLD >A> AB2 + 0.4MG/HR N74607 001 AUG 30, 1996 AUG CRLD >D> AB2 0.6MG/HR N74559 001 AUG 30, 1996 AUG CRLD >A> AB2 + 0.6MG/HR N74559 001 AUG 30, 1996 AUG CRLD >D> TRANSDERM-NITRO >D> AB2 + NOVARTIS 0.1MG/HR N20144 001 FEB 27, 1996 AUG DISC >A> @ 0.1MG/HR N20144 001 FEB 27, 1996 AUG DISC >D> AB2 + 0.2MG/HR N20144 002 FEB 27, 1996 AUG DISC >A> @ 0.2MG...
author: AUTHOR
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Prescription and Over-the-Counter Drug Product List: 5/2003
ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE TABLET; ORAL BUTALBITAL, APAP, AND CAFFEINE -A- AB AXIOM PHARM 325MG;50MG;40MG N89536 001 FEB 16, 1988 MAY CAHN -D- AB HALSEY 325MG;50MG;40MG N89536 001 FEB 16, 1988 MAY CAHN ACETAMINOPHEN; HYDROCODONE BITARTRATE TABLET; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN -A- AA ABLE 500MG;7.5MG...
author: AUTHOR
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Prescription and Over-the-Counter Drug Product List: 4/2003
45 -D- XCEL PHARMS 1MG/ML N05929 001 APR CFTG -A- AP + 1MG/ML N05929 001 APR CFTG -A- DIHYDROEROGTAMINE MESYLATE -A- AP PADDOCK 1MG/ML N40475 001 APR 28, 2003 APR NEWA DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE; ORAL -A- TAZTIA XT -A- AB4 ANDRX PHARMS 120MG N75401 001 APR 10, 2003 APR NEWA -A- AB4 180MG N75401 002 APR 10, 2003 APR NEWA -A- AB4 240MG N75401 003 APR 10,...
author: AUTHOR
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Prescription and Over-the-Counter Drug Product List: 3/2003
ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE CAPSULE; ORAL FIORICET W/ CODEINE -D- AB + NOVARTIS 325MG;50MG;40MG;30MG N20232 001 JUL 30, 1992 MAR CAHN -A- AB + WATSON PHARMS 325MG;50MG;40MG;30MG N20232 001 JUL 30, 1992 MAR CAHN ACETAMINOPHEN; CODEINE PHOSPHATE TABLET; ORAL CODRIX -A- + ANDRX PHARMS 500MG;30MG N40441 001...
author: AUTHOR
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FDA Drug Approvals List October 2001
Active Ingredient(s): OXAPROZIN OTC/RX Status: RX Original Abbreviated Application # 075839 Approval Date: 1-OCT-01 Trade Name: MINOXIDIL Dosage Form: SOLUTION Applicant: NOVEX PHARMA Active Ingredient(s): MINOXIDIL OTC/RX Status: RX Original Abbreviated and 505(b)(2) New Drug Applications with Tentative Approval Original Abbreviated Application #: 075834 Tentative Approval Date: 30...
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FDA Drug Approvals List February 2000
- Drug Approvals for February 2000 Definitions and Notes Original New Drug Applications Original Application #: 021015 Approval Date: 28-FEB-00 Trade Name: ANDROGEL Chemical Type: 3 Therapeutic Potential: S Dosage Form: GEL Applicant: UNIMED PHARMACEUTICALS INC Active Ingredient(s): TESTOSTERONE OTC/RX Status: RX Indication(s): For replacement therapy in males for conditions...
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http://www.fda.gov/cder/foi/appletter/2001/75500ltr.pdf
ANDA 75- 500 April 27, 2001 Upsher- Smith Laboratories, Inc
14905 23rd Avenue North Minneapolis, MN 55447- 2299 Dear Sir: This is in reference to your abbreviated new drug application dated November 10, 1998, submitted pursuant to Section 505( j) of the Federal Food, Drug, and Cosmetic Act (Act), for Sorine O (Sotalol Hydrochloride Tablets), 80 mg, 120 mg, 160 mg, and...

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http://www.fda.gov/cder/foi/appletter/2001/75500ltr.pdf page 1


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Prescription and OTC Drug Product List 11/1997
Prescription and Over-the-Counter Drug Product List - 17th Edition Cumulative Supplement Number 11: Jan '97 - Nov '97 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACARBOSE AMANTADINE HYDROCHLORIDE TABLET; ORAL CAPSULE; ORAL PRECOSE - DLT - SYMADINE - DLT - BAYER 25MG N20482 004 - DLT - AB SOLVAY 100MG N71000 001 - DLT - MAY 29, 1997 - DLT - SEP...
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Prescription and OTC Drug Product List 2/2000
Prescription and Over-the-Counter Drug Product List - 20th Edition Cumulative Supplement Number 2: February 2000 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; HYDROCODONE BITARTRATE CICLOPIROX TABLET; ORAL CREAM; TOPICAL LORTAB LOPROX - DLT - UCB 325MG;5MG N40099 001 - ADD - + AVENTIS PHARMS 0.77% N18748 001 - DLT - JUN 25, 1997 - ADD -...
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FDA Drug Approvals List January 2000
- Drug Approvals for January 2000 Definitions and Notes Original New Drug Applications Original Application #: 020939 Approval Date: 28-JAN-00 Trade Name: DILTIAZEM HCL Chemical Type: 5 Therapeutic Potential: S Dosage Form: CAPSULE, EXTENDED RELEASE Applicant: BIOVAIL LABORATORIES INC Active Ingredient(s): DILTIAZEM HYDROCHLORIDE OTC/RX Status: RX Indication(s): Treatment of...
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FDA Drug Approvals List July 2000
- Drug Approvals for July 2000 Definitions and Notes Original New Drug Applications Original Application #: 050779 Approval Date: 27-JUL-00 Trade Name: CEFAZOLIN AND DEXTROSE Chemical Type: 5 Therapeutic Potential: S Dosage Form: INJECTABLE Applicant: B BRAUN MEDICAL INC Active Ingredient(s): CEFAZOLIN SODIUM OTC/RX Status: RX Indication(s): For the treatment of respiratory tract...
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http://www.fda.gov/cder/foi/appletter/2000/75725ltr.pdf page 1


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http://www.fda.gov/cder/foi/appletter/2000/75429ltr.pdf
ANDA 75- 429 May 1, 2000 Teva Pharmaceuticals USA Attention: Deborah A
Jaskot 1510 Delp Drive Kulpsville, PA 19443 Dear Madam: This is in reference to your abbreviated new drug application dated July 31, 1998, submitted pursuant to Section 505( j) of the Federal Food, Drug, and Cosmetic Act (Act), for Sotalol Hydrochloride Tablets, 80 mg, 120 mg, 160 mg and 240 mg
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http://www.fda.gov/cder/foi/appletter/2000/75429ltr.pdf page 1


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http://www.fda.gov/cder/foi/appletter/1999/75237ta.pdf page 1


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FDA Drug Approvals List August 1999
Approvable Original New Drug Applications Original Application #: 021037 Approvable Date: 26-AUG-99 Trade Name: MAGNEVIST Dosage Form: INJECTABLE Applicant: BERLEX LABORATORIES INC Active Ingredient(s): GADOPENTETATE DIMEGLUMINE OTC/RX Status: RX Original Application #: 020989 Approvable Date: 27-AUG-99 Trade Name: EVOXAC Dosage Form: CAPSULE Applicant: SNOWBRAND PHARMACEUTICALS INC...
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75366.TAF.DOC
ANDA 75- 366 July 26, 1999 Eon Labs Manufacturing, Inc
Ciganek 227- 15 North Conduit Avenue Laurelton, NY 11413 Dear Madam: This is in reference to your abbreviated new drug application dated April 13, 1998, submitted pursuant to Section 505( j) of the Federal Food, Drug, and Cosmetic Act (Act), for Sotalol Hydrochloride Tablets 80 mg, 120 mg, 160 mg, and 240 mg
e.,...

author: Unknown
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75366.TAF.DOC page 1


author: Unknown
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75429LTR.PDF
ANDA 75- 429 July 20, 1999 TEVA Pharmaceuticals USA Attention: Deborah Jaskot 1510 Delp Drive Kulpsville, PA 19443 Dear Madam: This is in reference to your abbreviated new drug application dated July 31, 1998, submitted pursuant to Section 505( j) of the Federal Food, Drug, and Cosmetic Act (Act), for Sotalol Hydrochloride Tablets 80 mg, 120 mg, 160 mg, and 240 mg
author: Unknown
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75429LTR.PDF page 1


author: Unknown
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75238.TAF.DOC
ANDA 75- 238 June 7, 1999 Watson Laboratories, Inc
Box 1900 Corona, CA 91718- 1900 Dear Sir: This is in reference to your abbreviated new drug application dated October 31, 1997, submitted pursuant to Section 505( j) of the Federal Food, Drug, and Cosmetic Act (Act), for Sotalol Hydrochloride Tablets 80 mg, 120 mg, 160 mg, and 240 mg
Reference is also made to your...

author: Unknown
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