Drug Approvals - Z NDA 19-090/S-0037 10/29/99 - 4/16/03 Zantac (ranitidine hydrochloride) Injection & Premixed Injection GlaxoSmithKline NDA 19-090/S-045 & 19-593/S-033 1/7/02 2/8/02 Zantac (ranitidine hydrochloride) Tablets, Syrup, USP, GELdose Capsules & EFFERdose Tablets and Granules GlaxoSmithKline NDA 18-703/S-061, 19-675/S-025, 20-095/S-013 & 20-251/S-011 1/7/02 2/8/02 Zantac (Ranitidine ...
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...
http://www.fda.gov/cder/orange/appendix_a.txt 4, ACETAMINOPHEN TYLENOL W/ CODEINE, ACETAMINOPHEN TYLENOL, ACETAMINOPHEN (OTC) TYLOX, ACETAMINOPHEN TYLOX-325, ACETAMINOPHEN TYMTRAN, CERULETIDE DIETHYLAMINE TYZINE, TETRAHYDROZOLINE HYDROCHLORIDE TZ-3, TIOCONAZOLE (OTC) ** U ** U-CORT, HYDROCORTISONE ACETATE U-GENCIN, GENTAMICIN SULFATE UCEPHAN, SODIUM BENZOATE ULO, CHLOPHEDIANOL HYDROCHLORIDE ULTANE, SEVOFLURANE ULTIVA...
1999 Warning Letters and Untitled Letters to Pharmaceutical Companies DDMAC 1/21/99 1/26/99 Prograf (tacrolimus) capsules Fujisawa USA DDMAC 1/4/99 1/11/99 Remeron (mitrazapine) tablets Organon DDMAC 1/5/99 1/14/99 Risperdal (risperidone) tablets and oral solution Janssen Research DDMAC 1/5/99 1/14/99 Trivora, Zovia, Necon, Levora, Nor-QD Tablets Watson Laboratories DDMAC 1/26/99 2/12/99 February Arava (leflunomide) tablets Hoechst Marion Roussel DDMAC...
FDA Drug Approvals List April 2000 Approvable Original New Drug Applications Original Abbreviated New Drug Applications Original Abbreviated Application # 074657 Approval Date: 28-APR-00 Trade Name: TERAZOSIN HCL Dosage Form: TABLET Applicant: INVAMED INC Active Ingredient(s): TERAZOSIN HYDROCHLORIDE OTC/RX Status: RX Original Abbreviated Antibiotic Application# 065041 Approval Date: 28-APR-00 Trade Name:...
Prescription and OTC Drug Product List 8/1999 RTU IN PLASTIC CONTAINER - DLT - MAR 19, 1999 - ADD - AP + BAXTER HLTHCARE 500MG/100ML N18657 001 - DLT - AP + SCS 500MG/100ML N18657 001 LORACARBEF MINOCYCLINE HYDROCHLORIDE CAPSULE; ORAL LORABID CAPSULE; ORAL - ADD - KING PHARMS 200MG N50668 001 - DLT - MINOCYCLINE HCL - ADD - DEC 31, 1991 - DLT - AB WARNER CHILCOTT EQ 50MG BASE N63066 001 - ADD - + 400MG N50668 002 - DLT -...
Prescription and OTC Drug Product List 1/1999 Prescription and Over-the-Counter Drug Product List - 19th Edition Cumulative Supplement Number 1: January 1999 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; HYDROCODONE BITARTRATE BENDROFLUMETHIAZIDE; NADOLOL CAPSULE; ORAL TABLET; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN CORZIDE - ADD - AA MALLINCKRODT 500MG;5MG N88956 001 - ADD -...
Drug Approvals for April 1997 Drug Approvals for April 1997 Definitions and Notes April 1997 Original New Drug Applications Original Application #: 020619 Approval Date: 17-APR-97 Trade Name: BETOPTIC PILO Chemical Type: 4 Therapeutic Potential: S Dosage Form: SUSPENSION/DROPS Applicant: ALCON LABORATORIES INC Active Ingredient(s): BETAXOLOL HYDROCHLORIDE; PILOCARPINE HYDROCHLORIDE OTC/RX Status: RX...
FDA Drug Approvals List- March 1999 Drug Approvals for March 1999 Definitions and Notes March 1999 Original New Drug Applications Original Application #: 020966 Approval Date: 30-MAR-99 Trade Name: SPORANOX Chemical Type: 3 Therapeutic Potential: S Dosage Form: INJECTABLE Applicant: JANSSEN RESEARCH FDN DIV JOHNSON AND JOHNSON Active Ingredient(s): ITRACONAZOLE OTC/RX Status: RX Indication(s): For the treatment of...
Drug Approvals January 1997 Drug Approvals for January 1997 Definitions and Notes January 1997 Original New Drug Applications Original Application #: 050733 Approval Date: 30-JAN-97 Trade Name: ZITHROMAX Chemical Type: 3 Therapeutic Potential: S Dosage Form: INJECTABLE Applicant: PFIZER INC Active Ingredient(s): AZITHROMYCIN OTC/RX Status: RX Indication(s): Treatment of patients with community-acquired...
FDA Drug Approvals List- February 1999 Applicant: CONNETICS CORP Active Ingredient(s): BETAMETHASONE VALERATE OTC/RX Status: RX Indication(s):For the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses of the scalp Original Application #: 020969 Approval Date: 25-FEB-99 Trade Name: UVADEX Chemical Type: 3 Therapeutic Potential: S Dosage Form: SOLUTION Applicant: THERAKOS INC...
FDA Drug Approvals List- January 1999 Drug Approvals for January 1999 Definitions and Notes January 1999 Original New Drug Applications Original Application #: 020781 Approval Date: 27-JAN-99 Trade Name: ZOFRAN ODT Chemical Type: Therapeutic Potential: Dosage Form: TABLET Applicant: GLAXO WELLCOME INC Active Ingredient(s): ONDANSETRON OTC/RX Status: RX Indication(s): For the prevention of chemotherapy and...
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 overactive bladder with...
FDA Drug Approvals List August 1999 Original Application #: 020997 Approval Date: 05-AUG-99 Trade Name: CHIROCAINE Chemical Type: 2 Therapeutic Potential: S Dosage Form: INJECTABLE Applicant: DARWIN DISCOVERY LTD Active Ingredient(s): LEVOBUPIVACAINE HYDROCHLORIDE OTC/RX Status: RX Indication(s): For surgical anesthesia and pain management for adults Original Application #: 020902 Approval Date: 05-AUG-99 Trade...
DDPA November 1995 74-493 CAPTOPRIL PAR CAPTOPRIL 14-NOV-95 (TABLET) SPRING VALLEY, NY 12.5MG 10977 25MG 50MG 100MG (ANGIOTENSIN CONVERTING ENZYME INHIBITOR) ***LABELING SUPPLEMENTS TO ORIGINAL NDAs*** 19-543 ELOCON SCHERING MOMETASONE FUROATE 03-OCT-95 (OINTMENT) KENILWORTH, NJ 0.1% 07033 (LABELING REVISION -- INDICATIONS AND USAGE; PRECAUTIONS; ADVERSE REACTIONS; DOSAGE AND ADMINISTRATION) 19-625...
DDPA April 1995 74-481 CAPTOPRIL INVAMED CAPTOPRIL 28-APR-95 (TABLET) DAYTON, NJ 12.5MG 08810 25MG 50MG 100MG (ANGIOTENSIN CONVERTING ENZYME INHIBITOR) ***LABELING SUPPLEMENTS TO ORIGINAL NDAs*** 17-646 PERGONAL SERONO MENOTROPINS-- 05-APR-95 (INJECTABLE) BRAINTREE, MA FOLLICLE 02184 STIMULATING HORMONE 75IU/AMP LUTEINIZING HORMONE 75IU/AMP (LABELING REVISION -- ADVERSE REACTIONS) 17-646 PERGONAL...
DDPA January 1995 Drug and Device Product Approvals for January 1995 ***ORIGINAL AND SUPPLEMENTAL NDAs*** FOR NEW DRUG PRODUCTS 20-403 ZOFRAN GLAXO ONDANSETRON HYDROCHLORIDE 31-JAN-95 IN PLASTIC CONTAINER RES TRIANGLE PK, NC EQ 0.64MG BASE/ML (3 S) (INJECTABLE) 27709 (ANTIEMETIC) ***APPROVABLE ORIGINAL NDAs*** An approvable letter indicates that FDA is prepared to approve the...
DDPA May 1996 ***LABELING SUPPLEMENTS TO ORIGINAL NDAs*** 50-521 CECLOR ELI LILLY CEFACLOR 01-MAY-96 (CAPSULE) INDIANAPOLIS, IN EQ 250MG BASE 46285 EQ 500MG BASE (LABELING REVISION -- CLINICAL PHARMACOLOGY; ADVERSE REACTIONS) 50-522 CECLOR ELI LILLY CEFACLOR 01-MAY-96 (POWDER INDIANAPOLIS, IN EQ 125MG BASE/5ML FOR RECONSTITUTION) 46285 EQ 187MG BASE/5ML EQ 250MG BASE/5ML EQ 375MG BASE/5ML ...
DDPA March 1996 74-488 RANITIDINE HCL GRANUTEC RANITIDINE HYDROCHLORIDE 05-MAR-96 (TABLET) WILSON, NC EQ 150MG BASE 27896 EQ 300MG BASE (HISTAMINE H-2 RECEPTOR ANTAGONIST) ***LABELING SUPPLEMENTS TO ORIGINAL NDAs*** 04-570 HEPARIN SODIUM UPJOHN HEPARIN SODIUM 04-MAR-96 (INJECTABLE) KALAMAZOO, MI 1,000 UNITS/ML 49001 5,000 UNITS/ML 10,000 UNITS/ML (LABELING REVISION -- WARNINGS; PRECAUTIONS;...
Drug Approvals for October 1997 Drug Approvals for October 1997 Definitions and Notes October 1997 Original New Drug Applications Original Application #: 020755 Approval Date: 31-OCT-97 Trade Name: CAVERJECT Chemical Type: 5 Therapeutic Potential: S Dosage Form: INJECTABLE Applicant: PHARMACIA AND UPJOHN CO Active Ingredient(s): ALPROSTADIL OTC/RX Status: RX Indication(s): Provides for an aqueous formulation for...
http://www.fda.gov/cder/da/ddpa93.wpd 74 207 NAPROXEN COPLEY NAPROXEN 02 26 93 (TABLET) CANTON, MA 250MG 02021 375MG 500MG (NONSTEROIDAL ANTI INFLAMMATORY) 19 715 DIPENTUM KABI OLSALAZINE SODIUM 01 05 93 (CAPSULE) PISCATAWAY, NJ 250MG 08855 (REVISED LABELING CLINICAL PHARMACOLOGY; PRECAUTIONS; ADVERSE REACTIONS) 09 218 COUMADIN DUPONT WARFARIN SODIUM 02 01 93 (TABLET) WILMINGTON, DE 1MG 19880 2MG 2.5MG 5MG 7.5MG 10MG ...
Baxter Receives Tentative FDA Approvals for Ondansetron Injection in Vials and Premix Containers Food and Drug Administration (FDA) for Ondansetron Injection USP, including the first tentative approval for a premix version of GlaxoSmithKline's Zofran ®, which is used for the prevention of nausea and vomiting.Zofran ® is a registered trademark of GlaxoSmithKline - - This release includes forward-looking statements concerning the availability of ...
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AR 2007 Lo Res.pdf Barr Pharmaceuticals | 7 The Company has exclusive rights through Par to market, sell and distribute ondansetron orally disintegrating tablets, which are used for the prevention of nausea and vomiting associated with cancer therapy, and for the prevention of postoperative nausea and/ or vomiting.
