Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 009319
Company: FOREST LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMBENYL BROMODIPHENHYDRAMINE HYDROCHLORIDE; CODEINE PHOSPHATE 12.5MG/5ML;10MG/5ML SYRUP;ORAL Discontinued None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
04/28/1954 ORIG-1 Approval Type 4 - New Combination STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/14/1993 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

09/22/1989 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

11/10/1993 SUPPL-24 Labeling

Label is not available on this site.

08/26/1988 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

02/27/1986 SUPPL-21 Labeling

Label is not available on this site.

01/10/1984 SUPPL-18 Efficacy

Label is not available on this site.

01/10/1984 SUPPL-17 Manufacturing (CMC)-Formulation

Label is not available on this site.

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