Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 085940
Company: ALPHARMA US PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TRIPROLIDINE HYDROCHLORIDE TRIPROLIDINE HYDROCHLORIDE 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
07/13/1979 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
05/10/1989 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

05/10/1989 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

02/08/1989 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

02/08/1989 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

02/08/1989 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

03/20/1987 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

12/02/1986 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

08/05/1986 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

12/20/1985 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

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