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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 215138
Company: HIKMA

REMS

Products on ANDA 215138

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 215138

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/26/2022	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/31/2024	SUPPL-2	REMS - MODIFIED - D-N-A		Label is not available on this site.

Therapeutic Equivalents for ANDA 215138

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	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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