Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 085620
Company: DR REDDYS

Products on ANDA 085620

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 085620

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/02/1981	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
02/16/2024	SUPPL-20	Labeling-Package Insert		Label is not available on this site.
02/19/1999	SUPPL-18	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
02/02/1999	SUPPL-17	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
03/17/1998	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
12/04/1996	SUPPL-15	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
08/20/1996	SUPPL-14	Labeling		Label is not available on this site.
07/01/1991	SUPPL-13	Labeling		Label is not available on this site.
12/12/1990	SUPPL-12	Labeling		Label is not available on this site.
10/05/1988	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
10/05/1988	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
10/05/1988	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
05/01/1986	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
12/22/1983	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.