Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 073632
Company: GENUS
Company: GENUS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| METAPROTERENOL SULFATE | METAPROTERENOL SULFATE | 10MG/5ML | SYRUP;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 |
|---|---|---|---|---|---|---|---|
| 07/22/1992 | 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 |
|---|---|---|---|---|---|
| 07/11/2001 | SUPPL-9 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/01/1999 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/01/1999 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/06/1994 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/06/1994 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/06/1994 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/01/1993 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/28/1993 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |