Database D D - investigational drugs, therapies and vaccines # - A - B - C - D - E - F - G - H - I - J - K - L - M - N - O - P - Q - R - S - T - U - V - W - X - Y - Z From this page you may order documents with information covering investigational products.
Urinary Incontinence Urinary Incontinence (Overactive Bladder Syndrome) Extra Large Market.- Growing Market Prospective Market.- There are approximately 200 million people world-wide suffering from urinary incontinence, with less than 20% of them undergoing some form of the treatment.
Drug Approvals - D ANDA 74-904 7/14/98 7/14/98 - 3/16/99 Desoxyn (methamphetamine HCl) Tablets and Desoxyn (methamphetamine HCl) Gradumet Tablets, 5 mg & 5 mg, 10 mg, and 15 mg, Rx- Abbott Laboratories NDA 5-378/S-020 12/6/01 4/3/03 Detrol LA Extended- Release Capsules, Rx Pharmacia and Upjohn NDA 21-228 /S5 1/15 /04 1/22/04 - Detrol LA Extended- Release Capsules, Rx Pharmacia and Upjohn...
http://www.fda.gov/cder/orange/appendix_a.txt 45, DIHYDROERGOTAMINE MESYLATE DACARBAZINE, DACARBAZINE DALGAN, DEZOCINE DALMANE, FLURAZEPAM HYDROCHLORIDE DANAZOL, DANAZOL DANOCRINE, DANAZOL DANTRIUM, DANTROLENE SODIUM DAPSONE, DAPSONE DARANIDE, DICHLORPHENAMIDE DARAPRIM, PYRIMETHAMINE DARBID, ISOPROPAMIDE IODIDE DARICON, OXYPHENCYCLIMINE HYDROCHLORIDE DARVOCET A500, ACETAMINOPHEN DARVOCET, ACETAMINOPHEN DARVOCET-N 100,...
FDA Drug Approvals List September 2001 - Drug Approvals for September 2001 Definitions and Notes Original New Drug Applications Original Application #: 021279 Approval Date: 25-SEP-01 Trade Name: FORADIL Chemical Type: 3 Therapeutic Potential: S Dosage Form: POWDER, FOR INHALATION Applicant: NOVARTIS PHARMACEUTICALS CORP Active Ingredient(s): FORMOTEROL FUMARATE OTC/RX Status: RX Indication(s): For the long-term, twice...
FDA Drug Approvals List April 2001 - Drug Approvals for April 2001 Definitions and Notes Original New Drug Applications Original Application #: 020949 Approval Date: 30-APR-01 Trade Name: ACCUNEB Chemical Type: 5 Therapeutic Potential: S Dosage Form: SOLUTION Applicant: DEY LABORATORIES INC Active Ingredient(s): ALBUTEROL SULFATE OTC/RX Status: RX Indication(s): For the treatment of asthma-related bronchospasm in...
Prescription and OTC Drug Product List 12/2000 Prescription and Over-the-Counter Drug Product List - 20th Edition Cumulative Supplement Number 12: December 2000 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE - ADD - BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE TABLET; ORAL - ADD - GEL; TOPICAL OXYCODONE AND ACETAMINOPHEN - ADD - BENZACLIN - ADD - AA WATSON LABS...
FDA Drug Approvals List- March 1998 Drug Approvals for March 1998 Definitions and Notes March 1998 Original New Drug Applications Original Application #: 020827 Approval Date: 30-MAR-98 Trade Name: MONISTAT 3 Chemical Type: 3 Therapeutic Potential: S Dosage Form: CREAM Applicant: ADVANCED CARE PRODUCTS Active Ingredient(s): MICONAZOLE NITRATE OTC/RX Status: OTC Indication(s): For the over-the-counter treatment of...
FDA Drug Approvals List December 2000 - Drug Approvals for December 2000 Definitions and Notes Original New Drug Applications Original Application #: 021228 Approval Date: 22-DEC-00 Trade Name: DETROL LA Chemical Type: 3 Therapeutic Potential: S Dosage Form: CAPSULE Applicant: PHARMACIA AND UPJOHN CO Active Ingredient(s): TOLTERODINE TARTRATE OTC/RX Status: RX Indication(s): For the treatment of...
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...
Drug Approval Package FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER - Search - -Detrol LA (Tolterodine) Extended Release Capsules Company:- Pharmacia & Upjohn Co
http://www.ppti.com/downloads/PPTI_EIO_10_17_03.pdf * BOLD WORDS IN TEXT ARE REFERENCED IN GLOSSARY ON PAGES 43- 46.
http://www.ppti.com/downloads/PPTI_EIO_10_17_03.pdf page 16
C:\Data\My Documents\NDA 20771 S004 Detrol AP letter March.doc page 9
author: Evelyn Farinas
C:\Data\My Documents\NDA 20771 S004 Detrol AP letter March.doc page 8
author: Evelyn Farinas
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author: Evelyn Farinas
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author: Evelyn Farinas
C:\Data\My Documents\NDA 20771 S004 Detrol AP letter March.doc page 3
author: Evelyn Farinas
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author: Evelyn Farinas
C:\Data\My Documents\NDA 20771 S004 Detrol AP letter March.doc page 1
author: Evelyn Farinas
nda 21-228/s-002 detrol la page 6
subject: approved labeling
nda 21-228/s-002 detrol la page 4
subject: approved labeling
nda 21-228/s-002 detrol la page 3
subject: approved labeling
nda 21-228/s-002 detrol la page 2
subject: approved labeling
nda 21-228/s-002 detrol la page 1
subject: approved labeling
