Drug Approvals - A ANDA 76-130 9/26/02 Albuterol Sulfate Inhalation Solution, 0.083% (base), Breath Limited ANDA 76-370 11/24/03 -- - - Albuterol Sulfate Inhalation Solution, 0.0417% (base), Tentatively Approved Nephron Pharmaceuticals Corporation ANDA 76-355 11/7/03 -- - - Albuterol Sulfate Inhalation Solution, 0.5% (base) Nephron Pharmaceuticals Corporation ANDA 74-664 6/26/01 -- 4...
Drug Approvals - M NDA 21-460 10/21/02 10/28/02 10/25/02 4/30/03 Metaproterenol Sulfate Inhalation Solution USP, 0.4 & 0.6%, Rx Morton Grove Pharmaceuticals, IncMetaproterenol Sulfate Inhalation Solution USP, 0.6%, Rx Novex Pharma ANDA 75-403 2/28/01 3/6/01 - - Metaproterenol Sulfate Inhalation Solution USP, 0.4%, Rx Novex Pharma ANDA 75...
CDER Guidance Documents (Issued 8/2000, Posted 8/8/2000) Joint Safety/Efficacy (Multidisciplinary) (Draft) Submitting Marketing Applications According to the ICH/CTD Format: General Considerations (Issued 9/2001, Posted 9/5/2001) [ PDF ] M4 Common Technical Document--Quality: Questions and Answers/Location Issues [ HTML ] or [ PDF ] or [ ] (Issued 9/12/2002, Posted 12/30/2002) Quality Q1E Evaluation of...
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,...
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt "METAPROTERENOL SULFATE AS MFG
http://www.fda.gov/cder/guidance/guidlist.pdf page 4
http://www.fda.gov/cder/guidance/guidlist.pdf htm 301- 827- 4573 301- 827- 4577 Internet (I): E- mail: Tuesday, January 20, 2004 Table of Contents (by Subject Category) Current Good Manufacturing Practices Page 7 Page 9 Page 14 Page 14 Page 16 Page 17 Page 19 Page 23 Page 24 Page 25 Page 25 Page 26 Page 16 Page 18 Page 29 Advertising Page 3 Biopharmaceutics Page 3 Page 4 Chemistry Clinical Antimicrobial Clinical Medical Clinical...
ANDA Approvals May 2002 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Approvals - May 2002 - ANDA Number Drug Name Applicant Approval Date 1 65-036 IDARUBICIN HYDROCHLORIDE INJECTION 1 MG/ML; (5 MG/5 ML, 10 MG/10 ML, AND 20 MG/20 ML SINGLE-DOSE VIALS) GENSIA SICOR PHARMACEUTICALS, INC
author: OGD
ANDA Approvals February 2001 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Approvals February 2001 ANDA NUMBER DRUG- NAME APPLICANT APPROVAL DATE 1 65-061 CLINDAMYCIN HYDROCHLORIDE CAPSULES, USP 150 MG (BASE)------- 300 MG (BASE) RANBAXY LABORATORIES LIMITED 2/2/01 2 75-738 PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN TABLETS, USP 100 MG/650 MG MALLINCKRODT INC
author: USERNAME
FDA Drug Approvals List February 2001 Approvable Original New Drug Applications - Original Abbreviated New Drug Applications Original Abbreviated Application # 075402 Approval Date: 28-FEB-01 Trade Name: METAPROTERENOL SULFATE Dosage Form: SOLUTION Applicant: NOVEX PHARMA Active Ingredient(s): METAPROTERENOL SULFATE OTC/RX Status: RX Original Abbreviated Application # 075403 Approval Date: 28-FEB...
FDA Drug Approvals List May 2002 - Drug Approvals for May 2002 Definitions and Notes Original New Drug Applications Original Abbreviated Antibiotic Application # 065082 Approval Date: 31-MAY-02 Trade Name: CEFPODOXIME PROXETIL Dosage Form: GRANULE, FOR RECONSTITUTION Applicant: RANBAXY LABORATORIES LTD Active Ingredient(s): CEFPODOXIME PROXETIL OTC/RX Status: RX Original Application #: 021292 Approval Date: 31-MAY...
Prescription and OTC Drug Product List 11/2001 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE TABLET; ORAL PERCOCET -A- + ENDO PHARMS 325MG;7.5MG N40434 001 NOV 23, 2001 NOV NEWA -A- + 325MG;10MG N40434 002 NOV 23, 2001 NOV NEWA ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE CAPSULE; ORAL BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE -A- AB ANABOLIC 325MG;50MG;40MG;30MG...
Prescription and OTC Drug Product List 8/2001 ACTHAR GEL -D- BC + AVENTIS 40 UNITS/ML N08372 006 FEB 06, 1956 AUG CAHN -D- BC + 80 UNITS/ML N08372 008 FEB 06, 1956 AUG CAHN -A- BC + QUESTCOR PHARMS 40 UNITS/ML N08372 006 FEB 06, 1956 AUG CAHN -A- BC + 80 UNITS/ML N08372 008 FEB 06, 1956 AUG CAHN DELAVIRDINE MESYLATE TABLET; ORAL RESCRIPTOR -D- + AGOURON 100MG N20705 001 APR 04, 1997 AUG CRLD -A- 100MG N20705 001 APR 04, 1997 AUG...
Prescription and OTC Drug Product List 11/2002 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST TABLET; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN -A- AA ABLE 325MG;5MG N40478 001 NOV 08, 2002 NOV NEWA -A- AA 500MG;10MG N40473 001 NOV 06, 2002 NOV NEWA -A- AA 500MG;5MG N40477 001 NOV 06, 2002 NOV NEWA AMCINONIDE LOTION; TOPICAL -A- AMCINONIDE -A- AB ALTANA 0.1% N76329 001 NOV 06, 2002 NOV NEWA CYCLOCORT -D- + FUJISAWA...
Prescription and OTC Drug Product List 6/2002 -D- + WYETH AYERST 20,000 UNITS/VIAL N17055 003 JUN DISC -A- @ 20,000 UNITS/VIAL N17055 003 JUN DISC CHORIONIC GONADOTROPIN -D- + STERIS 2,000 UNITS/VIAL N17016 011 FEB 16, 1990 JUN DISC -A- @ 2,000 UNITS/VIAL N17016 011 FEB 16, 1990 JUN DISC GRANISETRON HYDROCHLORID E SOLUTION; ORAL KYTRIL -D- + ROCHE EQ 2MG BASE/10ML N21238 001 JUN 27, 2001 JUN DISC -A- @ EQ 2MG BASE/10ML N21238...
Prescription and OTC Drug Product List 5/2002 2 -D- + ROBINS AH 325MG;15MG N84444 001 MAY DISC -A- @ 325MG;15MG N84444 001 MAY DISC SOLUTION; ORAL ACETAMINOPHEN AND CODEINE PHOSPHATE -D- AA ALPHARMA 120MG/5ML;12MG/5ML N85861 001 MAY CRLD -A- AA + 120MG/5ML;12MG/5ML N85861 001 MAY CRLD TYLENOL W/ CODEINE -D- AA + JOHNSON RW 120MG/5ML;12MG/5ML N85057 001 MAY DISC -A- @ 120MG/5ML;12MG/5ML N85057 001 MAY DISC TABLET; ORAL...
Reviewer Guidance For Nebulizers, Metered Dose Inhalers, Spacers and Actuators FDA Home Page | CDRH Home Page | Search | CDRH A-Z Index | Contact CDRH CDRH Final Guidance Cover Sheet Reviewer Guidance For Nebulizers, Metered Dose Inhalers, Spacers and Actuators This guidance was written prior to the February 27, 1997 implementation of FDA's Good Guidance Practices, GGP's
author: Emil Wang
withdrawn.PDF page 2
author: walshju
CDER Guidance Documents (Issued 8/2000, Posted 8/8/2000) Joint Safety/Efficacy (Multidisciplinary) (Draft) M2 Electronic Common Technical Document Specification [ HTML ] or [ PDF ] (Issued 6/2002, Posted 6/13/2002) Submitting Marketing Applications According to the ICH/CTD Format: General Considerations (Issued 9/2001, Posted 9/5/2001) [ PDF ] M4 Common Technical Document--Quality: Questions and Answers...
Comprehensive List of Current Guidance Documents at the Food and Drug Administration page 37
author: FDA
Comprehensive List of Current Guidance Documents at the Food and Drug Administration page 29
author: FDA
Quarterly List of Guidance Documents at the Food and Drug Administration page 12
author: FDA
Annual Comprehensive List of Guidance Documents at the Food and Drug Administration 141 / Friday, July 21, 2000 / Notices Name of Document Date of Issuance Grouped by Intended User or Regulatory Activity How to Obtain a Hard Copy of the Document (Name and Address, Phone, FAX, E- mail or Internet) Consumer- Directed Broadcast Advertisements August 9, 1999 Do Do Antifungal (topical) February 24, 1990 Biopharmaceutic Draft Do Antifungal (vaginal) February 24, 1990 Do...
author: FDA
subject: 7/21/2000
Annual Comprehensive List of Guidance Documents at the Food and Drug Administration page 33
author: FDA
subject: 7/21/2000
Annual Comprehensive List of Guidance Documents at the Food and Drug Administration page 20
author: FDA
subject: 7/21/2000
