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FDA NDA 012575, ACTIFED W/ CODEINE, GLAXOSMITHKLINE, 01/00/1900

FDA NDA 012575, ACTIFED W/ CODEINE, GLAXOSMITHKLINE, 01/00/1900

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$506.25 USD
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Contents: Summary Basis of Approval for the NDA 012575 ACTIFED W/ CODEINE.

NDA: 012575
Company: GLAXOSMITHKLINE
Drug Name: ACTIFED W/ CODEINE
Active Ingredients: CODEINE PHOSPHATE; PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE
Strength: 10MG/5ML;30MG/5ML;1.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage Form/Route: SYRUP;ORAL
Marketing Status: Discontinued (
Submission Classification:
Action Date: None

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