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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075231
Company: LGM PHARMA

REMS

Products on ANDA 075231

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE	ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE	325MG;50MG;40MG;30MG	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075231

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/30/2001	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75231ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/12/2024	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
02/12/2024	SUPPL-10	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
02/12/2024	SUPPL-9	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
09/18/2018	SUPPL-8	REMS - PROPOSAL - D-N-A		Label is not available on this site.
02/12/2024	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
11/20/2015	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
08/20/2002	SUPPL-3	Manufacturing (CMC)-Packaging		Label is not available on this site.
12/17/2002	SUPPL-2	Labeling		Label is not available on this site.
12/17/2002	SUPPL-1	Manufacturing (CMC)-Packaging		Label is not available on this site.

Therapeutic Equivalents for ANDA 075231

BUTALBITAL, ASPIRIN, 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, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE	ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE	325MG;50MG;40MG;30MG	CAPSULE;ORAL	Prescription	No	AB	075231	LGM PHARMA
BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE	ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE	325MG;50MG;40MG;30MG	CAPSULE;ORAL	Prescription	No	AB	074951	STEVENS J

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