http://www.fda.gov/cder/orange/appendix_a.txt ACTHAR GEL, CORTICOTROPIN H.R.-50, HYDROCHLOROTHIAZIDE HABITROL, NICOTINE (OTC) HALCION, TRIAZOLAM HALDOL SOLUTAB, HALOPERIDOL HALDOL, HALOPERIDOL HALDOL, HALOPERIDOL DECANOATE HALDOL, HALOPERIDOL LACTATE HALDRONE, PARAMETHASONE ACETATE HALFAN, HALOFANTRINE HYDROCHLORIDE HALOG, HALCINONIDE HALOG-E, HALCINONIDE HALOPERIDOL DECANOATE, HALOPERIDOL DECANOATE HALOPERIDOL INTENSOL,...
20508S005_Lac-Hydrin (Ammonium Lactate) Cream Food and Drug Administration • Center for Drug Evaluation and Research Approval Package Search Lac -Hydrin (Ammonium Lactate) Cream Company:--Bristol Myers Squibb Company Application No.:--20-508/S005 Approval Date:-8/25/2000 - Approval Letter(s) - Printed Labeling - Medical Review(s) - Chemistry Review(s) - Pharmacology Review(s) - Statistical Review(s)...
author: Paul Stauffer
Paddock Laboratories, Inc. - Other RX's BACITRACIN USP STERILE BELLADONNA & OPIUM SUPPOSITORIES COLISTIN SULFATE USP POWDER COLOCORT® Hydrocortisone Rectal Suspension, USP (Retention) COMPRO™ Prochlorperazine Suppositories, USP 25mg DEXAMETHASONE SODIUM PHOSPHATE USP POWDER HYDROCORTISONE ACETATE USP MICRONIZED POWDER HYDROCORTISONE ACETATE SUPPOSITORIES (Hemorrhoidal HC Suppositories) HYDROCORTISONE USP...
OGD, First Time Approvals - May 2002 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search First-Time Generics - May 2002 Generic Drug Name Generic Manufacturer Brand Name Approval Date 1- IDARUBICIN HYDROCHLORIDE FOR INJECTION, USP 5 MG, 10 MG, AND 20 MG SINGLE-DOSE VIALS GENSIA SICOR PHARMACEUTICALS, INCAMMONIUM LACTATE ...
author: OGD
CDER Template - Replace Title Here Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search First-Time Generics - June 2002 - Generic Drug Name Generic Manufacturer Brand Name Approval Date- 1- AMOXICILLIN AND CLAVULANATE POTASSIUM FOR ORAL SUSPENSION, U 200 MG/28.5 MG (BASE)/5 ML, AND 400 MG/57 MG (BASE)/5 ML GENEVA PHARMACEUTICALS, INC
author: USERNAME
Paddock Laboratories, Inc. - Dermatology AQUABASE™ (Anhydrous Hydrophilic Ointment) BENZOIN COMPOUND TINCTURE USP DERMABASE™ (Oil-in-Water Emulsion Base) HYDROCREAM BASE™ (Water-in-Oil Cream Base) LAClotion™ 12% (Ammonium Lactate) Lotion LANOLIN USP (Anhydrous) LIQUA-GEL™ Aqueous Gel Vehicle LIQUA-GEL™, PUMPS FOR NYSTOP® nystatin topical powder, USP PODOCON-25® (25%...
Paddock Laboratories, Inc. - Diabetes GLUTOL™ (Contains: 100 gm Dextrose/180 mL prepared for the performance of the Glucose Tolerance Test) GLUTOSE 15™ (Oral Glucose Gel for Hypoglycemia) Free Patient Education Materials on Hypoglycemia GLUTOSE 45™(Oral Glucose Gel for Hypoglycemia) LAClotion™ 12% (Ammonium Lactate) Lotion PADDOCK NEWS Secundum Artem TM Now available in PDF form
Paddock Laboratories, Inc. - Key Products Master Product List Actidose® Activated Charcoal Colocort® Hydrocortisone Rectal Suspension Compounding Actives, Vehicles, Stability Studies Compro™ Prochlorperazine Suppositories Encort™ Hydrocortisone Acetate Suppositories 30 mg Dihydroergotamine Mesylate Injection, USP EZ-Char™ Activated Charcoal USP Glutose™ For Hypoglycemia FREE Patient Education...
Prescription and OTC Drug Product List 6/2002 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; HYDROCODONE BITARTRATE TABLET; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN -D- AA PEACHTREE 500MG;10MG N40210 001 AUG 13, 1997 JUN CAHN -A- AA UCB 500MG;10MG N40210 001 AUG 13, 1997 JUN CAHN ACETAMINOPHEN; PROPOXYPHENE HYDROCHLORIDE TABLET; ORAL DARVOCET -A- @ AAIPHARMA LLC 325MG;32.5MG N16844 001 JUN CAHN -D- @...
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...
Laclotion sell sheet ** Lac - Hydrin ® is a registered trademark of Westwood- Squibb Pharmaceuticals, IncLac - Hydrin ® 12% Lotion
author: george_haeger
Laclotion sell sheet page 2
author: george_haeger
Prescription and OTC Drug Product List 10/1998 Prescription and Over-the-Counter Drug Product List - 18th Edition Cumulative Supplement Number 10: October 1998 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE BENZYL PENICILLOYL-POLYLYSINE CAPSULE; ORAL INJECTABLE; INJECTION BUTALBITAL, ACETAMINOPHEN AND CAFFEINE PRE-PEN - ADD - AB WEST WARD 500MG;50MG;40MG N40261...
PDPL PRESCRIPTION DRUG PRODUCT LIST- 16TH EDITION RX DRUG PRODUCT LIST / CUMULATIVE SUPPLEMENT NUMBER 8 / JAN'96 - AUG'96 ACETAMINOPHEN; BUTALBITAL ALPRAZOLAM TABLET; ORAL TABLET; ORAL BUTALBITAL AND ACETAMINOPHEN ALPRAZOLAM - DLT - AB HALSEY 325MG;50MG N89568 001 - ADD - AB NOVOPHARM 2MG N74085 004 - DLT - OCT 05, 1988 - ADD - FEB 26, 1996 - ADD - @ 325MG;50MG N89568 001 - ADD - OCT 05,...
FDA Drug Approvals List August 2000 Original Application #: 021197 Approval Date: 11-AUG-00 Trade Name: CETROTIDE Chemical Type: 1 Therapeutic Potential: S Dosage Form: INJECTABLE Applicant: ASTA MEDICA INC Active Ingredient(s): CETRORELIX OTC/RX Status: RX Indication(s): For the prevention of premature LH surges in women undergoing controlled ovarian stimulation Original Application #: 021128 Approval Date: 01-AUG-00...
DDPA August 1996 DEPARTMENT OF HEALTH AND HUMAN SERVICES, PUBLIC HEALTH SERVICE NDA NUMBER TRADE NAME APPLICANT ACTIVE INGREDIENT(S) APPROVAL DATE (DOSAGE FORM) STRENGTH(S) (CLASSIFICATION) CLASSIFICATION(S) ***ORIGINAL AND SUPPLEMENTAL NDAs*** FOR NEW DRUG PRODUCTS 19-640 HUMATROPE LILLY SOMATROPIN, BIOSYNTHETIC 01-AUG-96 (INJECTABLE) INDIANAPOLIS, IN 5MG/VIAL (SUPPL-013) 45285 (NEW INDICATION --...
August Drug Approvals Original Application #: 020508 Approval Date: 29-AUG-96 Trade Name: LAC -HYDRIN Chemical Type: 3 Therapeutic Potential: S Dosage Form: CREAM Applicant: BRISTOL MYERS CO Active Ingredient(s): AMMONIUM LACTATE OTC/RX Status: RX Indication(s): ICHTHYOSIS VULGARIS AND XEROSIS Original Application #: 020532 Approval Date: 26-AUG-96 Trade Name: IVY BLOCK Chemical...
Pediatric Exclusivity Labeling Changes Food and Drug Administration • Center for Drug Evaluation and Research Pediatrics Search Pediatric Exclusivity Labeling Changes as of February 6, 2004 - - Exclusivity Granted (Labeled) Product Indications Label Changes 1Ammonium lactate - Lac -Hydrin (Westwood-Squibb) Label [PDF ] Xerosis, ichthyosis Safety and effectiveness established in...
Laclotion sell sheet page 1
author: george_haeger
http://www.fda.gov/cder/pediatric/labels/AmmonLactate.pdf Rx only LAC - HYDRIN 12%* (ammonium lactate cream) Cream For Dermatologic use only*LAC - HYDRIN is a formulation of 12% lactic acid neutralized with ammonium hydroxide, as ammonium lactate with a pH of 4.4 5.4LAC - HYDRIN Cream also contains water, light mineral oil, glyceryl stearate, polyoxyl 100 stearate,...
http://www.fda.gov/cder/pediatric/labels/AmmonLactate.pdf page 2
duplicates:http://www.fda.gov/cder/foi/label/2000/20508S5lbl.pdf
http://www.fda.gov/cder/pediatric/labels/AmmonLactate.pdf page 1
duplicates:http://www.fda.gov/cder/foi/label/2000/20508S5lbl.pdf
http://www.fda.gov/cder/foi/label/2000/20508S5lbl.pdf Rx only LAC - HYDRIN 12%* (ammonium lactate cream) Cream For Dermatologic use only*LAC - HYDRIN is a formulation of 12% lactic acid neutralized with ammonium hydroxide, as ammonium lactate with a pH of 4.4 5.4LAC - HYDRIN Cream also contains water, light mineral oil, glyceryl stearate, polyoxyl 100 stearate,...
http://www.fda.gov/cder/foi/appletter/2000/20508S5ltr.pdf NDA 20- 508/ S- 005 Bristol- Myers Squibb Company Attention: David Silberstein Director, Worldwide Regulatory Affairs PLac - Hydrin (ammonium lactate cream) Cream, 12%...
http://www.fda.gov/cder/foi/appletter/2000/20508S5ltr.pdf page 1
