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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020713
Company: TEVA BRANDED PHARM

Products on NDA 020713

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MIRCETTE	DESOGESTREL; ETHINYL ESTRADIOL	0.15MG,N/A;0.02MG,0.01MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL-28	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020713

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/22/1998	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20713.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/04/2023	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020713s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/020713Orig1s013ltr.pdf
04/29/2022	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020713s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/020713Orig1s012ltr.pdf
08/09/2017	SUPPL-11	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020713s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020713Orig1s011ltr.pdf
07/18/2012	SUPPL-10	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020713s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020713Orig1s010ltr.pdf
03/08/2002	SUPPL-8	Manufacturing (CMC)-Control		Label is not available on this site.
10/03/2000	SUPPL-7	Labeling		Label is not available on this site.
11/27/2000	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
08/30/2000	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
02/15/2000	SUPPL-4	Labeling		Label is not available on this site.
03/16/1999	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
11/19/1998	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 020713

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/04/2023	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020713s013lbl.pdf
04/29/2022	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020713s012lbl.pdf
08/09/2017	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020713s011lbl.pdf
07/18/2012	SUPPL-10	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020713s010lbl.pdf

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