Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 214087
Company: SENORES PHARMS
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 No
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE ACETAMINOPHEN; BUTALBITAL; CAFFEINE 325MG;50MG;40MG CAPSULE;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
08/13/2021 ORIG-1 Approval STANDARD

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 215047 RICONPHARMA LLC
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE ACETAMINOPHEN; BUTALBITAL; CAFFEINE 300MG;50MG;40MG CAPSULE;ORAL Prescription No AA 214087 SENORES PHARMS
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

CAPSULE;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 CAPSULE;ORAL Prescription No AA 204733 AUROLIFE PHARMA LLC
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE ACETAMINOPHEN; BUTALBITAL; CAFFEINE 325MG;50MG;40MG CAPSULE;ORAL Prescription No AA 212083 LANNETT CO INC
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE ACETAMINOPHEN; BUTALBITAL; CAFFEINE 325MG;50MG;40MG CAPSULE;ORAL Prescription No AA 089007 MAYNE PHARMA INC
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE ACETAMINOPHEN; BUTALBITAL; CAFFEINE 325MG;50MG;40MG CAPSULE;ORAL Prescription No AA 214087 SENORES PHARMS

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English