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 LGM PHARMA
Abbreviated New Drug Application (ANDA): 040885
Company: LGM PHARMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | ACETAMINOPHEN; BUTALBITAL; CAFFEINE | 300MG;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 |
|---|---|---|---|---|---|---|---|
| 11/16/2009 | ORIG-1 | Approval |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/040885Orig1s000.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/30/2014 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/23/2011 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
CAPSULE;ORAL; 300MG;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 | 300MG;50MG;40MG | CAPSULE;ORAL | Prescription | No | AA | 213321 | GRANULES |
| BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | ACETAMINOPHEN; BUTALBITAL; CAFFEINE | 300MG;50MG;40MG | CAPSULE;ORAL | Prescription | No | AA | 212082 | LANNETT CO INC |
| BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | ACETAMINOPHEN; BUTALBITAL; CAFFEINE | 300MG;50MG;40MG | CAPSULE;ORAL | Prescription | No | AA | 040885 | LGM PHARMA |
| BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | ACETAMINOPHEN; BUTALBITAL; CAFFEINE | 300MG;50MG;40MG | CAPSULE;ORAL | Prescription | No | AA | 210817 | MAYNE PHARMA INC |
| BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | ACETAMINOPHEN; BUTALBITAL; CAFFEINE | 300MG;50MG;40MG | CAPSULE;ORAL | Prescription | No | AA | 207118 | NUVO PHARMS INC |
| BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | ACETAMINOPHEN; BUTALBITAL; CAFFEINE | 300MG;50MG;40MG | CAPSULE;ORAL | Prescription | No | AA | 213046 | TARO PHARM INDS LTD |
| BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | ACETAMINOPHEN; BUTALBITAL; CAFFEINE | 300MG;50MG;40MG | CAPSULE;ORAL | Prescription | No | AA | 206615 | XSPIRE PHARMA |
منبع : www.accessdata.fda.gov
نظرات کاربران