Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 072761
Company: COSETTE
Company: COSETTE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| METAPROTERENOL SULFATE | METAPROTERENOL SULFATE | 10MG/5ML | SYRUP;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 |
|---|---|---|---|---|---|---|---|
| 02/27/1992 | 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 |
|---|---|---|---|---|---|
| 07/07/2000 | SUPPL-11 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 10/30/1997 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/13/1997 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/31/1996 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/16/1995 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/06/1994 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/02/1993 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/28/1993 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/02/1993 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/25/1992 | SUPPL-2 | Labeling |
Label is not available on this site. |
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| 04/20/1992 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |