Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090956
Company: LGM PHARMA

Products on ANDA 090956

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BUTALBITAL AND ACETAMINOPHEN	ACETAMINOPHEN; BUTALBITAL	300MG;50MG	TABLET;ORAL	Prescription	AA	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 090956

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/23/2011	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
04/09/2014	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 090956

BUTALBITAL AND ACETAMINOPHEN

TABLET;ORAL; 300MG;50MG
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BUTALBITAL AND ACETAMINOPHEN	ACETAMINOPHEN; BUTALBITAL	300MG;50MG	TABLET;ORAL	Prescription	No	AA	090956	LGM PHARMA
BUTALBITAL AND ACETAMINOPHEN	ACETAMINOPHEN; BUTALBITAL	300MG;50MG	TABLET;ORAL	Prescription	No	AA	207386	MIKART
BUTALBITAL AND ACETAMINOPHEN	ACETAMINOPHEN; BUTALBITAL	300MG;50MG	TABLET;ORAL	Prescription	No	AA	214955	NE RX PHARMA
BUTALBITAL AND ACETAMINOPHEN	ACETAMINOPHEN; BUTALBITAL	300MG;50MG	TABLET;ORAL	Prescription	No	AA	214305	QUAGEN
BUTALBITAL AND ACETAMINOPHEN	ACETAMINOPHEN; BUTALBITAL	300MG;50MG	TABLET;ORAL	Prescription	No	AA	214088	SENORES PHARMS