Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 080571
Company: DR REDDYS
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
THIAMINE HYDROCHLORIDE THIAMINE HYDROCHLORIDE 200MG/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
02/26/1974 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-144 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

02/02/1999 SUPPL-142 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

08/28/1996 SUPPL-141 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

11/14/1994 SUPPL-140 Labeling

Label is not available on this site.

12/14/1992 SUPPL-139 Manufacturing (CMC)

Label is not available on this site.

09/22/1992 SUPPL-137 Manufacturing (CMC)

Label is not available on this site.

09/22/1992 SUPPL-136 Manufacturing (CMC)

Label is not available on this site.

09/22/1992 SUPPL-135 Manufacturing (CMC)

Label is not available on this site.

01/11/1988 SUPPL-133 Manufacturing (CMC)

Label is not available on this site.

05/28/1986 SUPPL-131 Manufacturing (CMC)

Label is not available on this site.

12/13/1985 SUPPL-130 Manufacturing (CMC)

Label is not available on this site.

12/13/1985 SUPPL-129 Manufacturing (CMC)

Label is not available on this site.

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