Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074834
Company: CHARTWELL MOLECULES
Company: CHARTWELL MOLECULES
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ACYCLOVIR | ACYCLOVIR | 400MG | TABLET;ORAL | Discontinued | None | No | No |
ACYCLOVIR | ACYCLOVIR | 800MG | 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 |
---|---|---|---|---|---|---|---|
04/24/1997 | 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 |
---|---|---|---|---|---|
09/13/2000 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
10/27/1998 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
03/26/1998 | SUPPL-1 | Labeling |
Label is not available on this site. |