Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 087750
Company: CHARTWELL
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. |
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05/11/2015 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
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06/19/2014 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
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03/24/1993 | SUPPL-8 | Labeling |
Label is not available on this site. |
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05/07/1992 | SUPPL-7 | Labeling |
Label is not available on this site. |
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03/04/1992 | SUPPL-6 | Labeling |
Label is not available on this site. |
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04/10/1989 | SUPPL-5 | Labeling |
Label is not available on this site. |
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03/06/1989 | SUPPL-4 | Labeling |
Label is not available on this site. |
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07/01/1988 | SUPPL-3 | Labeling |
Label is not available on this site. |