Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 201333
Company: NATCO PHARMA
Company: NATCO PHARMA
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 |
---|---|---|---|---|---|---|---|
03/24/2011 | ORIG-1 | Approval | Not Applicable |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
09/21/2021 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
09/21/2021 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
09/21/2021 | SUPPL-2 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
05/18/2015 | SUPPL-1 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |