An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 209587
Company: LGM PHARMA

Products on ANDA 209587

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 209587

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.

Therapeutic Equivalents for ANDA 209587

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	Yes	AA	088616	ACTAVIS LABS UT INC
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	ACETAMINOPHEN; BUTALBITAL; CAFFEINE	325MG;50MG;40MG	TABLET;ORAL	Prescription	No	AA	040864	GRANULES
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	214287	QUAGEN
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	ACETAMINOPHEN; BUTALBITAL; CAFFEINE	325MG;50MG;40MG	TABLET;ORAL	Prescription	No	AA	040511	STRIDES PHARMA INTL

Top