Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 080572
Company: DR REDDYS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PYRIDOXINE HYDROCHLORIDE PYRIDOXINE 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
02/13/1974 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-147 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

02/02/1999 SUPPL-146 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

08/28/1996 SUPPL-145 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

12/26/1990 SUPPL-144 Labeling

Label is not available on this site.

04/03/1989 SUPPL-143 Manufacturing (CMC)

Label is not available on this site.

08/03/1988 SUPPL-141 Manufacturing (CMC)

Label is not available on this site.

08/03/1988 SUPPL-140 Manufacturing (CMC)

Label is not available on this site.

06/16/1986 SUPPL-138 Manufacturing (CMC)

Label is not available on this site.

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