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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020946
Company: TEVA BRANDED PHARM

Products on NDA 020946

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PREVEN EMERGENCY CONTRACEPTIVE KIT	ETHINYL ESTRADIOL; LEVONORGESTREL	0.05MG;0.25MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020946

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/01/1998	ORIG-1	Approval	Type 3 - New Dosage Form	PRIORITY	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20946lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20946ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20946.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/13/2002	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
11/19/2002	SUPPL-9	Manufacturing (CMC)-Control		Label is not available on this site.
02/21/2002	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
02/21/2002	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
07/17/2001	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
04/03/2000	SUPPL-5	Labeling		Label is not available on this site.
08/02/2000	SUPPL-4	Manufacturing (CMC)-Control		Label is not available on this site.
05/23/2000	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
02/02/2000	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
06/07/1999	SUPPL-1	Labeling	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20946S001_Preven.pdf

Labels for NDA 020946

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/01/1998	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20946lbl.pdf

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