Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040085
Company: MIKART
Company: MIKART
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ESGIC-PLUS | ACETAMINOPHEN; BUTALBITAL; CAFFEINE | 500MG;50MG;40MG | CAPSULE;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 |
---|---|---|---|---|---|---|---|
03/28/1996 | 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 |
---|---|---|---|---|---|
08/13/2002 | SUPPL-14 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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03/27/2001 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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03/27/2001 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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07/31/1998 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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02/19/1998 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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02/19/1998 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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07/17/2000 | SUPPL-8 | Labeling |
Label is not available on this site. |
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04/20/1998 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |