Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 088833
Company: WOCKHARDT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TRIPROLIDINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE AND CODEINE PHOSPHATE CODEINE PHOSPHATE; PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE 10MG/5ML;30MG/5ML;1.25MG/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
11/16/1984 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
12/01/1998 SUPPL-23 Labeling

Label is not available on this site.

11/20/1990 SUPPL-20 Labeling

Label is not available on this site.

05/24/1990 SUPPL-19 Labeling

Label is not available on this site.

01/22/1990 SUPPL-18 Labeling

Label is not available on this site.

02/13/1989 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

05/14/1987 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

05/14/1987 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

08/10/1987 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

08/10/1987 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

05/30/1986 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

12/18/1986 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

07/24/1985 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

12/13/1984 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

12/13/1984 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

12/13/1984 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

12/13/1984 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

12/13/1984 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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