Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078278
Company: CIPLA
Company: CIPLA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
FAMCICLOVIR | FAMCICLOVIR | 125MG | TABLET;ORAL | Discontinued | None | No | No |
FAMCICLOVIR | FAMCICLOVIR | 250MG | TABLET;ORAL | Discontinued | None | No | No |
FAMCICLOVIR | FAMCICLOVIR | 500MG | 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 |
---|---|---|---|---|---|---|---|
03/21/2011 | 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 |
---|---|---|---|---|---|
07/08/2019 | SUPPL-10 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
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07/08/2019 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
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06/30/2015 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
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05/13/2011 | SUPPL-2 | Labeling-Container/Carton Labels |
Label is not available on this site. |