Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075406
Company: WATSON LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OGESTREL 0.5/50-21 ETHINYL ESTRADIOL; NORGESTREL 0.05MG;0.5MG TABLET;ORAL-21 Discontinued None No No
OGESTREL 0.5/50-28 ETHINYL ESTRADIOL; NORGESTREL 0.05MG;0.5MG TABLET;ORAL-28 Prescription None No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/15/1999 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/75406ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/09/2017 SUPPL-24 Labeling-Package Insert

Label is not available on this site.

07/19/2017 SUPPL-23 Labeling-Package Insert

Label is not available on this site.

12/04/2008 SUPPL-16 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/075406s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/075406Orig1s016ltr.pdf
10/04/2006 SUPPL-11 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/04/2008 SUPPL-16 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/075406s016lbl.pdf

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