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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076560
Company: LGM PHARMA

REMS

Products on ANDA 076560

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
BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE	300MG;50MG;40MG;30MG	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076560

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/10/2004	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-8	REMS - PROPOSAL - D-N-A		Label is not available on this site.
03/25/2016	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
10/21/2011	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
07/19/2012	SUPPL-4	Labeling		Label is not available on this site.
07/19/2012	SUPPL-3	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 076560

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	215138	HIKMA
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

CAPSULE;ORAL; 300MG;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	300MG;50MG;40MG;30MG	CAPSULE;ORAL	Prescription	No	AB	215138	HIKMA
BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE	300MG;50MG;40MG;30MG	CAPSULE;ORAL	Prescription	No	AB	076560	LGM PHARMA

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