اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE از شرکت ACTAVIS LABS UT INC
Abbreviated New Drug Application (ANDA): 088616
Company: ACTAVIS LABS UT INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | ACETAMINOPHEN; BUTALBITAL; CAFFEINE | 325MG;50MG;40MG | TABLET;ORAL | Prescription |
AA |
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 |
|---|---|---|---|---|---|---|---|
| 11/09/1984 | 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 |
|---|---|---|---|---|---|
| 12/10/2014 | SUPPL-64 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/23/2011 | SUPPL-62 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/06/2002 | SUPPL-45 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/15/2001 | SUPPL-44 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/30/2001 | SUPPL-43 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/18/2002 | SUPPL-41 | Labeling |
Label is not available on this site. |
||
| 07/26/1999 | SUPPL-40 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/01/1999 | SUPPL-39 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/01/1999 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/01/1999 | SUPPL-37 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/16/1998 | SUPPL-36 | Labeling |
Label is not available on this site. |
||
| 11/20/1996 | SUPPL-35 | Labeling |
Label is not available on this site. |
||
| 04/23/1996 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/20/1998 | SUPPL-33 | Labeling |
Label is not available on this site. |
||
| 08/04/1995 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/16/1995 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/27/1993 | SUPPL-29 | Labeling |
Label is not available on this site. |
||
| 08/20/1993 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/16/1992 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
| 01/30/1992 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 12/17/1991 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 05/26/1992 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/03/1991 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/05/1991 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 09/11/1990 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 08/24/1990 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 05/10/1990 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 03/21/1990 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/21/1990 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/05/1991 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 05/15/1989 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 03/21/1990 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/21/1990 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/18/1988 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/19/1986 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/19/1986 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/19/1986 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/19/1986 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/19/1985 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/19/1985 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/30/1985 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/19/1985 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
TABLET;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 | TABLET;ORAL | Prescription | No | AA | 211106 | ABHAI LLC |
| BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | ACETAMINOPHEN; BUTALBITAL; CAFFEINE | 325MG;50MG;40MG | TABLET;ORAL | Prescription | No | AA | 088616 | ACTAVIS LABS UT INC |
| BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | ACETAMINOPHEN; BUTALBITAL; CAFFEINE | 325MG;50MG;40MG | TABLET;ORAL | Prescription | No | AA | 204984 | ALVOGEN |
| BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | ACETAMINOPHEN; BUTALBITAL; CAFFEINE | 325MG;50MG;40MG | TABLET;ORAL | Prescription | No | AA | 200243 | LANNETT CO INC |
| BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | ACETAMINOPHEN; BUTALBITAL; CAFFEINE | 325MG;50MG;40MG | TABLET;ORAL | Prescription | No | AA | 209587 | LGM PHARMA |
| BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | ACETAMINOPHEN; BUTALBITAL; CAFFEINE | 325MG;50MG;40MG | TABLET;ORAL | Prescription | No | AA | 089175 | MIKART |
| BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | ACETAMINOPHEN; BUTALBITAL; CAFFEINE | 325MG;50MG;40MG | TABLET;ORAL | Prescription | No | AA | 211543 | NESHER PHARMS |
| BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | ACETAMINOPHEN; BUTALBITAL; CAFFEINE | 325MG;50MG;40MG | TABLET;ORAL | Prescription | No | AA | 203647 | STRIDES PHARMA |
| BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | ACETAMINOPHEN; BUTALBITAL; CAFFEINE | 325MG;50MG;40MG | TABLET;ORAL | Prescription | No | AA | 040511 | VINTAGE PHARMS |
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