Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 080365
Company: DR REDDYS

Products on ANDA 080365

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CHLORPROMAZINE HYDROCHLORIDE	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 080365

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
02/05/2020	SUPPL-167	Labeling-Package Insert		Label is not available on this site.
02/23/2017	SUPPL-166	Labeling-Package Insert		Label is not available on this site.
11/03/2015	SUPPL-165	Labeling-Package Insert		Label is not available on this site.
02/19/1999	SUPPL-163	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
02/02/1999	SUPPL-162	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
12/04/1996	SUPPL-161	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
03/27/1998	SUPPL-160	Manufacturing (CMC)		Label is not available on this site.
08/16/1995	SUPPL-159	Manufacturing (CMC)		Label is not available on this site.
05/11/1992	SUPPL-158	Labeling		Label is not available on this site.
05/27/1992	SUPPL-157	Manufacturing (CMC)		Label is not available on this site.
04/10/1991	SUPPL-156	Labeling		Label is not available on this site.
01/11/1990	SUPPL-155	Labeling		Label is not available on this site.
10/16/1989	SUPPL-153	Manufacturing (CMC)		Label is not available on this site.
07/02/1991	SUPPL-152	Manufacturing (CMC)		Label is not available on this site.
07/02/1991	SUPPL-151	Manufacturing (CMC)		Label is not available on this site.
07/02/1991	SUPPL-150	Manufacturing (CMC)		Label is not available on this site.
10/16/1989	SUPPL-149	Manufacturing (CMC)		Label is not available on this site.
10/16/1989	SUPPL-148	Manufacturing (CMC)		Label is not available on this site.
04/18/1989	SUPPL-147	Manufacturing (CMC)		Label is not available on this site.
04/18/1989	SUPPL-146	Manufacturing (CMC)		Label is not available on this site.
04/18/1989	SUPPL-145	Manufacturing (CMC)		Label is not available on this site.
04/10/1989	SUPPL-139	Bioequivalence		Label is not available on this site.
04/20/1989	SUPPL-138	Bioequivalence		Label is not available on this site.
06/16/1986	SUPPL-137	Manufacturing (CMC)		Label is not available on this site.
06/30/1988	SUPPL-41	Labeling		Label is not available on this site.