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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077099
Company: VINTAGE PHARMS LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ORSYTHIA ETHINYL ESTRADIOL; LEVONORGESTREL 0.02MG;0.1MG TABLET;ORAL-28 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
05/11/2011 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/29/2022 SUPPL-8 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

08/09/2017 SUPPL-7 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

04/30/2014 SUPPL-5 Labeling-Container/Carton Labels

Label is not available on this site.

01/03/2012 SUPPL-1 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

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