BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE از شرکت NOSTRUM LABS INC

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, CAFFEINE AND CODEINE PHOSPHATE از شرکت NOSTRUM LABS INC

Abbreviated New Drug Application (ANDA): 075929

Company: NOSTRUM LABS INC

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE 325MG;50MG;40MG;30MG CAPSULE;ORAL Prescription

AB

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
04/22/2002 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
09/18/2018 SUPPL-24 REMS – PROPOSAL – D-N-A

Label is not available on this site.

08/04/2014 SUPPL-13 Labeling-Package Insert

Label is not available on this site.

08/15/2013 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

11/29/2011 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

09/19/2008 SUPPL-5 Labeling

Label is not available on this site.

02/15/2008 SUPPL-4 Labeling

Label is not available on this site.

10/25/2007 SUPPL-3 Labeling

Label is not available on this site.

BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE

CAPSULE;ORAL; 325MG;50MG;40MG;30MG

TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE 325MG;50MG;40MG;30MG CAPSULE;ORAL Prescription No AB 076560 LGM PHARMA
BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE 325MG;50MG;40MG;30MG CAPSULE;ORAL Prescription No AB 075929 NOSTRUM LABS INC
BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE 325MG;50MG;40MG;30MG CAPSULE;ORAL Prescription No AB 204649 STRIDES PHARMA
FIORICET W/ CODEINE ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE 325MG;50MG;40MG;30MG CAPSULE;ORAL Prescription Yes AB 020232 ACTAVIS LABS UT INC
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