Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 080572
Company: DR REDDYS

Products on ANDA 080572

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 080572

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.