Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 085498
Company: COSETTE
Company: COSETTE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TRUPHYLLINE | AMINOPHYLLINE | 250MG | SUPPOSITORY;RECTAL | Discontinued | None | No | No |
| TRUPHYLLINE | AMINOPHYLLINE | 500MG | SUPPOSITORY;RECTAL | 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 |
|---|---|---|---|---|---|---|---|
| 01/03/1983 | 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 |
|---|---|---|---|---|---|
| 10/14/1997 | SUPPL-14 | Labeling |
Label is not available on this site. |
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| 05/01/1992 | SUPPL-13 | Labeling |
Label is not available on this site. |
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| 07/15/1991 | SUPPL-12 | Labeling |
Label is not available on this site. |
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| 06/18/1990 | SUPPL-11 | Labeling |
Label is not available on this site. |
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| 12/29/1988 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 11/05/1985 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/27/1983 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/22/1983 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/22/1983 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |