Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040387
Company: MIKART
Company: MIKART
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | ACETAMINOPHEN; BUTALBITAL; CAFFEINE | 325MG/15ML;50MG/15ML;40MG/15ML | SOLUTION;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 |
---|---|---|---|---|---|---|---|
01/31/2003 | 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 |
---|---|---|---|---|---|
10/18/2013 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
06/22/2011 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
07/06/2009 | SUPPL-10 | Labeling |
Label is not available on this site. |