Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 072237
Company: COSETTE
Company: COSETTE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ACEPHEN | ACETAMINOPHEN | 650MG | 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 |
---|---|---|---|---|---|---|---|
03/27/1992 | 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 |
---|---|---|---|---|---|
11/10/2015 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
11/10/2015 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
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09/24/2013 | SUPPL-9 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
08/19/2010 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
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08/19/2010 | SUPPL-7 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
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04/29/1999 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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10/04/1996 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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07/10/1992 | SUPPL-1 | Labeling |
Label is not available on this site. |