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
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BUTALBITAL, ACETAMINOPHEN AND CAFFEINE از شرکت LGM PHARMA

Abbreviated New Drug Application (ANDA): 209587

Company: LGM PHARMA

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
10/31/2018 ORIG-1 Approval

STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/28/2018 SUPPL-1 Labeling-Container/Carton Labels

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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