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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040885
Company: LGM PHARMA

Products on ANDA 040885

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	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040885

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/16/2009	ORIG-1	Approval			Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/040885Orig1s000.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/30/2014	SUPPL-2	Labeling-Package Insert		Label is not available on this site.
06/23/2011	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 040885

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	210817	DR REDDYS LABS SA
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	215047	NOVAST LABS
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	214288	QUAGEN
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
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	ACETAMINOPHEN; BUTALBITAL; CAFFEINE	300MG;50MG;40MG	CAPSULE;ORAL	Prescription	No	AA	206615	XSPIRE PHARMA

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