Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078515
Company: BARR

Products on ANDA 078515

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DROSPIRENONE AND ETHINYL ESTRADIOL	DROSPIRENONE; ETHINYL ESTRADIOL	3MG;0.02MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 078515

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/30/2009	ORIG-1	Approval			Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/078515s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/078515Orig1s000correctedltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/06/2015	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
10/06/2015	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
07/02/2010	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
07/02/2010	SUPPL-5	Labeling-Package Insert		Label is not available on this site.

Labels for ANDA 078515

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/30/2009	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/078515s000lbl.pdf