Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 083714
Company: DR REDDYS

Products on ANDA 083714

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ESTRADIOL VALERATE	ESTRADIOL VALERATE	40MG/ML	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 083714

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/28/1979	ORIG-1	Approval			Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/083714.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/19/1999	SUPPL-64	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
09/25/1998	SUPPL-63	Manufacturing (CMC)		Label is not available on this site.
02/02/1999	SUPPL-62	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
01/17/1997	SUPPL-61	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
08/16/1996	SUPPL-60	Labeling		Label is not available on this site.
10/01/1991	SUPPL-59	Labeling		Label is not available on this site.
05/01/1991	SUPPL-58	Labeling		Label is not available on this site.
12/18/1990	SUPPL-57	Labeling		Label is not available on this site.
03/15/1991	SUPPL-56	Labeling		Label is not available on this site.
02/07/1991	SUPPL-54	Manufacturing (CMC)		Label is not available on this site.
10/28/1988	SUPPL-53	Manufacturing (CMC)		Label is not available on this site.
10/28/1988	SUPPL-52	Manufacturing (CMC)		Label is not available on this site.
05/02/1986	SUPPL-45	Manufacturing (CMC)		Label is not available on this site.
09/05/1984	SUPPL-44	Manufacturing (CMC)		Label is not available on this site.