Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 085239
Company: DR REDDYS

Products on ANDA 085239

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ESTRONE	ESTRONE	5MG/ML	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 085239

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/21/1979	ORIG-1	Approval			Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/085239_estrone_toc.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/03/2017	SUPPL-61	Labeling-Package Insert		Label is not available on this site.
02/19/1999	SUPPL-59	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
02/02/1999	SUPPL-58	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
05/13/1998	SUPPL-57	Manufacturing (CMC)		Label is not available on this site.
08/20/1996	SUPPL-56	Labeling		Label is not available on this site.
05/01/1991	SUPPL-55	Labeling		Label is not available on this site.
03/28/1991	SUPPL-54	Labeling		Label is not available on this site.
02/22/1991	SUPPL-53	Manufacturing (CMC)		Label is not available on this site.
02/22/1991	SUPPL-52	Manufacturing (CMC)		Label is not available on this site.
08/28/1989	SUPPL-51	Labeling		Label is not available on this site.
12/28/1988	SUPPL-50	Manufacturing (CMC)		Label is not available on this site.
12/28/1988	SUPPL-49	Manufacturing (CMC)		Label is not available on this site.
03/01/1988	SUPPL-44	Manufacturing (CMC)		Label is not available on this site.
05/01/1986	SUPPL-40	Manufacturing (CMC)		Label is not available on this site.
08/24/1983	SUPPL-38	Manufacturing (CMC)		Label is not available on this site.