Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 085470
Company: PFIZER

Products on ANDA 085470

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DEPO-ESTRADIOL	ESTRADIOL CYPIONATE	1MG/ML	INJECTABLE;INJECTION	Discontinued	None	No	No
DEPO-ESTRADIOL	ESTRADIOL CYPIONATE	3MG/ML	INJECTABLE;INJECTION	Discontinued	None	No	No
DEPO-ESTRADIOL	ESTRADIOL CYPIONATE	5MG/ML	INJECTABLE;INJECTION	Prescription	None	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 085470

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/15/1979	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
02/21/2024	SUPPL-27	Labeling-Package Insert		Label is not available on this site.
05/03/2019	SUPPL-23	Labeling-Package Insert		Label is not available on this site.
06/15/2005	SUPPL-15	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/085470s015lbl.pdf
05/28/2002	SUPPL-13	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
04/05/2000	SUPPL-12	Manufacturing (CMC)-Facility		Label is not available on this site.
06/01/1998	SUPPL-10	Labeling		Label is not available on this site.
07/01/1982	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
07/01/1982	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.

Labels for ANDA 085470

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/15/2005	SUPPL-15	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/085470s015lbl.pdf