Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 088896
Company: WOCKHARDT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROMETHAZINE VC W/ CODEINE CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE 10MG/5ML;5MG/5ML;6.25MG/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
01/04/1985 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/23/1990 SUPPL-15 Labeling

Label is not available on this site.

05/22/1989 SUPPL-14 Labeling

Label is not available on this site.

08/16/1988 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

04/07/1987 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

04/07/1987 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

04/07/1987 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

04/07/1987 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

04/07/1987 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

06/02/1986 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

03/06/1986 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

03/06/1986 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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