BioPortfolio Client Press Releases Site Map Hana Biosciences Announces Positive Pharmacokinetic Study Results Of Ondansetron Lingual Spray PharmaVentures announces launch of ddcr.com New web site to enable drug delivery deal making Why Aren't Drugs Safer?
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 ...
Drug Approvals - O ANDA 75-347 3/23/00 3/31/00 - - Omnicef (cefdinir) Capsules,- Abbott Laboratories NDA 50-739/S-006 7/24/02 8/6/02 Omnicef (cefdinir) Capsules,- Parke-Davis NDA 50-739/S-002 11/24/99 12/30/99 12/30/99 - Omnicef (cefdinir) Powder Oral Suspension Parke-Davis NDA 50-749/SE2-002 7/14/99 7/29/99 7/29/99 - - Omnicef Indication: 5-day dosing regimen (7 mg/kg BID) for the treatment of AOM...
What's new at CDER by Date Avastin Information Page New and Generic Drug Approvals Advil Liqui- Gels & Migraine Liqui-Gels (ibuprofen), Wyeth Consumer Didronel (Etidronate Disodium) Tablets, Procter and Gamble Loprox (ciclopirox) Shampoo, Medicis Pharmaceutical Corporation Semprex-D (acrivastine and pseudoephedrine) Capsules, Celltech Pharmaceuticals Fosinopril Sodium Tablets, Eon Labs, Tentative Approval ...
author: Paul Stauffer
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...
http://www.fda.gov/cder/dmf/text/4Q2003NEWTEXT.txt PETERSBURG, FL." 16976 II 25-Nov-2003 TARO PHARMACEUTICAL INDUSTRIES LTD "ONDANSETRON HYDROCHLORIDE AS MANUFACTURED IN HAIFA BAY, ISRAEL." 16977 II 21-Nov-2003 CHENG FONG CHEMICAL CO LTD "PSEUDOEPHEDRINE HYDROCHLORIDE AS MANUFACTRUED IN TAO YUAN HSIEN, TAIWAN." 16978 II 19-Nov-2003 CARDINAL HEALTH "RISPERIDONE 0.5 MG AND 1.0 MG ORALLY DISINTEGRATING TABLETS AS...
http://www.fda.gov/cder/dmf/xls/4Q2003NEWEXCEL.xls II RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA SPA SERTRALINE HYDROCHLORIDE FORM II AS MANUFACTURED IN CAMPOVERDE DI APRILIA (LT), ITALYHYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA II NICHOLAS PIRAMAL INDIA LTD ITRACONAZOLE AS MANUFACTURED IN ANDHRA...
OGD Suitability Tracking Reports (Sorted by Petition Number) as of 1/5/2004 - - Pending - CYCLOBENZAPRINE HYDROCHLORIDE 7.5 MG - 03P-0461/CP1 ANABOLIC LABORATORIES - - Pending 10/1/2003- CLONAZEPAM 1 MG/5 ML - 03P-0464/CP1 LACHMAN CONSULTANT SERVICES - ORAL SOLUTION Pending 10/2/2003- HYDROCODONE BITARTRATE 5 MG ACETAMINOPHEN 325 MG - 03P-0475/CP1 INT'L REGULATORY BUSINESS CONS - LIQUID; ORAL Pending - ACETAMINOPHEN 770 MG, 385 MG CAFFEINE 60 MG, 30 MG...
OGD Suitability Tracking Reports (Sorted by Drug Name) as of 1/5/2004 - CREAM; TOPICAL Denied 7/3/2002- LOPERAMIDE HYDROCHLORIDE 1 MG - 02P-0424/CP1 BANNER PHARMACAPS - CAPSULE; ORAL Approved 4/14/2003- LOPERAMIDE HYDROCHLORIDE 2 mg - 02P-0380/CP1 BANNER PHARMACAPS - SOFT GELATIN CAPSULES Pending - MERCAPTOPURINE 100 MG - 00P-1645/CP1 McKENNA & CUNEO - TABLET; ORAL Approved 4/17/2001- METFORMIN HYDROCHLORIDE 1000 MG - 03P-0388/CP1...
http://www.paddocklabs.com/forms/secundum/volume_9_2.pdf Drug therapy has included neuroleptics (haloperidol, prochlorperazine), antihistamines (cyclizine, hydroxyzine, dimenhydrinate), anticholinergics (hyoscine), prokinetics (metoclopramide, domperidone, cisapride), 5HT3 antagonists (ondansetron, granisetron), corticosteroids (dexamethasone) and benzodiazepinesHydrochloride Epidural...
http://www.paddocklabs.com/forms/secundum/volume_9_2.pdf page 5
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:...
Handbook 8/02 corr for Web page 4
author: Diane Ward
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...
http://www.fda.gov/cder/rdmt/escy99ap.htm - - - - - - - - - - TERBINAFINE HYDROCHLORIDE NOVARTIS 20-980 03/30/98 03/09/99 N 0 N 11.3 Rx to OTC switch for the treatment of tinea pedis (athlete's foot), tinea cruris (jock itch) and tinea corporis (ringworm)ONDANSETRON HYDROCHLORIDE GLAXO WELLCOME 20-103 08/28/98 08/27/99 SE1 15 N 12.0 Prevention of nausea and vomiting associated with...
author: Darlene
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 radiation...
FDA Drug Approvals List December 2000 Active Ingredient(s): ONDANSETRON OTC/RX Status: RX Application #: 020459 Labeling Supplement#: 002 To Original New Drug Application Approval Date: 12-DEC-00 Trade Name: REVEX Dosage Form: INJECTABLE Applicant: BAXTER PHARMACEUTICAL PRODUCTS INC Active Ingredient(s): NALMEFENE HYDROCHLORIDE OTC/RX Status: RX Application #: 020865 Labeling Supplement#: 007 To Original New...
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...
