Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074346
Company: ADAPTIS
Company: ADAPTIS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PASER | AMINOSALICYLIC ACID | 4GM/PACKET | GRANULE, DELAYED RELEASE;ORAL | Prescription | None | No | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 06/30/1994 | 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 |
|---|---|---|---|---|---|
| 08/27/1996 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 02/21/1996 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/23/1996 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/27/1996 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/27/1996 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/01/1995 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/01/1995 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/01/1995 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |