Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020569
Company: BAUSCH AND LOMB
Company: BAUSCH AND LOMB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
VITRASERT | GANCICLOVIR | 4.5MG | IMPLANT;IMPLANTATION | 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 |
---|---|---|---|---|---|---|---|
03/04/1996 | ORIG-1 | Approval | Type 3 - New Dosage Form | PRIORITY; Orphan |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/18/2000 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
08/04/1999 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
05/14/1999 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/26/1997 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
10/17/1997 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
12/20/1996 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |