Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 088897
Company: WOCKHARDT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROMETHAZINE VC PLAIN PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE 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
04/04/1990 SUPPL-12 Labeling

Label is not available on this site.

04/05/1989 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

01/31/1989 SUPPL-10 Labeling

Label is not available on this site.

08/17/1988 SUPPL-9 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.

04/07/1987 SUPPL-3 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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