Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 087750
Company: CHARTWELL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VIRILON METHYLTESTOSTERONE 10MG CAPSULE;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
11/24/1982 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
01/26/2017 SUPPL-16 Labeling-Package Insert

Label is not available on this site.

05/11/2015 SUPPL-15 Labeling-Package Insert

Label is not available on this site.

06/19/2014 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

03/24/1993 SUPPL-8 Labeling

Label is not available on this site.

05/07/1992 SUPPL-7 Labeling

Label is not available on this site.

03/04/1992 SUPPL-6 Labeling

Label is not available on this site.

04/10/1989 SUPPL-5 Labeling

Label is not available on this site.

03/06/1989 SUPPL-4 Labeling

Label is not available on this site.

07/01/1988 SUPPL-3 Labeling

Label is not available on this site.

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