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  Current Search:  klaron: 11, sulfacetamide: 72  
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1996 and Older - New Drug Application (NDA)
New Drug Approval Packages These drug approval packages, sorted by product trade name, are supplied by the CDER Freedom of Electronic Information Office
20195/S-002 5/20/96 8/2/99 Fragmin/dalteparin sodium Injection [1.5 MB] Pharmacia and Upjohn 020287/S005 9/24/1996 2/4/1998 Heptolite, Kit for the Preparation of Technetium Tc 99m Disofenin Merck 18467/ S-13 & S-14 12/29/1993 8/5...
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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,...

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Drug Approvals December 1996
Drug Approvals for December 1996 Definitions and Notes December 1996 Original New Drug Applications Original Application #: 020681 Approval Date: 31-DEC-96 Trade Name: ORTHO TRI-CYCLEN Chemical Type: 6 Therapeutic Potential: S Dosage Form: TABLET Applicant: RW JOHNSON PHARMACEUTICAL RESEARCH INSTITUTE DIV ORTHO PHARMACEUTICAL CORP Active Ingredient(s): ETHINYL ESTRADIOL; NORGESTIMATE...
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Drug Approvals - K
Product Name Company Application # Approval Date Letter Posted Label Posted Review Posted Kaletra (lopinavir) oral solution, 80mg lopinavir/20mg ritonavir
Kanamycin Injection USP, 500 mg/2 mL & 1 g/3 mL, Rx American Pharmaceutical Partners, Inc
NDA 21-035/S13 & S19 5/22/02 5/29/0 2 - - Keppra (levetiracetam)- Tablets, 250 mg, 500 mg, and 750 mg
ANDA76-092 12/28/01 4/16/03...
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This document has been prepared by the Labeling Department to match the content and style of the original printed insert as cl
KLARON (sodium sulfacetamide lotion) Lotion, 10% DESCRIPTION Each mL of Klaron ® (sodium sulfacetamide lotion) Lotion, 10% contains 100 mg of sodium sulfacetamide in a vehicle consisting of purified water; propylene glycol; lauramide DEA (and) diethanolamine; polyethylene glycol 400, monolaurate; hydroxyethyl cellulose; sodium chloride; sodium metabisulfite;...

author: Christopher J. Di Pompeo subject: Klaron Lotion 10% 2 Fl Oz and 8 mL
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This document has been prepared by the Labeling Department to match the content and style of the original printed insert as cl page 2


author: Christopher J. Di Pompeo subject: Klaron Lotion 10% 2 Fl Oz and 8 mL
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This document has been prepared by the Labeling Department to match the content and style of the original printed insert as cl page 1


author: Christopher J. Di Pompeo subject: Klaron Lotion 10% 2 Fl Oz and 8 mL
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DOCUMENT INFORMATION PAGE page 1


author: DeCamp
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