Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 089987
Company: MIKART
Company: MIKART
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BUTAPAP | ACETAMINOPHEN; BUTALBITAL | 325MG;50MG | TABLET;ORAL | Prescription | AA | 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 |
|---|---|---|---|---|---|---|---|
| 10/26/1992 | 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 |
|---|---|---|---|---|---|
| 10/18/2013 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/22/2011 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/13/2002 | SUPPL-10 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 03/28/2001 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/28/2001 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/25/1998 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/31/1998 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/24/2000 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 08/13/1996 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/08/1995 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/08/1994 | SUPPL-1 | Labeling |
Label is not available on this site. |
BUTAPAP
TABLET;ORAL; 325MG;50MG
TE Code = AA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BUTALBITAL AND ACETAMINOPHEN | ACETAMINOPHEN; BUTALBITAL | 325MG;50MG | TABLET;ORAL | Prescription | No | AA | 203484 | LARKEN LABS INC |
| BUTALBITAL AND ACETAMINOPHEN | ACETAMINOPHEN; BUTALBITAL | 325MG;50MG | TABLET;ORAL | Prescription | No | AA | 214291 | QUAGEN |
| BUTALBITAL AND ACETAMINOPHEN | ACETAMINOPHEN; BUTALBITAL | 325MG;50MG | TABLET;ORAL | Prescription | No | AA | 214088 | SENORES PHARMS |
| BUTAPAP | ACETAMINOPHEN; BUTALBITAL | 325MG;50MG | TABLET;ORAL | Prescription | No | AA | 089987 | MIKART |