Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 086577
Company: WATSON LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TRIMETHOBENZAMIDE HYDROCHLORIDE TRIMETHOBENZAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE;INJECTION 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
10/19/1982 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
02/19/1999 SUPPL-12 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

02/02/1999 SUPPL-11 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

12/04/1996 SUPPL-9 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

08/06/1992 SUPPL-8 Labeling

Label is not available on this site.

09/30/1991 SUPPL-7 Labeling

Label is not available on this site.

02/23/1991 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

02/23/1991 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

02/23/1991 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

04/30/1986 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

04/02/1984 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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