Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 074951
Company: STEVENS J

• REMS

Products on ANDA 074951

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	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 074951

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/31/1998	ORIG-1	Approval			Letter (PDF) Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74951ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/074951_butalbital_toc.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/15/2023	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
12/11/2023	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
09/18/2018	SUPPL-4	REMS - PROPOSAL - D-N-A		Label is not available on this site.
11/09/2007	SUPPL-2	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 074951

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