Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074346
Company: EUROCEPT PHARMS
Company: EUROCEPT PHARMS
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. |
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02/21/1996 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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04/23/1996 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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08/27/1996 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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08/27/1996 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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02/01/1995 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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02/01/1995 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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02/01/1995 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |