Drugs@FDA: FDA Approved Drug Products

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