Drugs@FDA: FDA-Approved Drugs
Company: DR REDDYS LABS SA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | ACETAMINOPHEN; BUTALBITAL; CAFFEINE | 325MG;50MG;40MG | CAPSULE;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 |
|---|---|---|---|---|---|---|---|
| 03/17/1986 | 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-44 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/22/2011 | SUPPL-43 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/08/2003 | SUPPL-38 | Labeling |
Label is not available on this site. |
||
| 08/13/2002 | SUPPL-37 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 03/28/2001 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/31/1998 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/06/1998 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/06/1998 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/06/1998 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/23/2001 | SUPPL-31 | Labeling |
Label is not available on this site. |
||
| 04/06/1998 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/22/1996 | SUPPL-29 | Labeling |
Label is not available on this site. |
||
| 09/15/1995 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/08/1995 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/15/1993 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 12/03/1991 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 12/31/1990 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 12/31/1990 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/31/1990 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/31/1990 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/14/1989 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/03/1988 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/03/1988 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/26/1988 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 10/26/1988 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 09/20/1988 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 03/29/1988 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/04/1992 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/02/1987 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/03/1988 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/29/1988 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/29/1988 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/29/1988 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/29/1988 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/29/1988 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/29/1988 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/19/1986 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/19/1986 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
CAPSULE;ORAL; 325MG;50MG;40MG
TE Code = AA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | ACETAMINOPHEN; BUTALBITAL; CAFFEINE | 325MG;50MG;40MG | CAPSULE;ORAL | Prescription | No | AA | 204733 | AUROLIFE PHARMA LLC |
| BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | ACETAMINOPHEN; BUTALBITAL; CAFFEINE | 325MG;50MG;40MG | CAPSULE;ORAL | Prescription | No | AA | 089007 | DR REDDYS LABS SA |
| BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | ACETAMINOPHEN; BUTALBITAL; CAFFEINE | 325MG;50MG;40MG | CAPSULE;ORAL | Prescription | No | AA | 212083 | LANNETT CO INC |
| BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | ACETAMINOPHEN; BUTALBITAL; CAFFEINE | 325MG;50MG;40MG | CAPSULE;ORAL | Prescription | No | AA | 216376 | QUAGEN |
| BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | ACETAMINOPHEN; BUTALBITAL; CAFFEINE | 325MG;50MG;40MG | CAPSULE;ORAL | Prescription | No | AA | 214087 | SENORES PHARMS |