BUTALBITAL, ACETAMINOPHEN AND CAFFEINE از شرکت LGM PHARMA

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

Review (PDF)

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
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