Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 080575
Company: WEST-WARD PHARMS INT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
THIAMINE HYDROCHLORIDE THIAMINE 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
06/24/1975 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
10/27/2000 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

09/08/1997 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

02/27/1996 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

04/23/1991 SUPPL-15 Labeling

Label is not available on this site.

12/19/1988 SUPPL-14 Labeling

Label is not available on this site.

11/03/1986 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

11/03/1986 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

09/13/1983 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

09/22/1982 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

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