Alprazolam Oral Solution

Category(s): prescription
SPL Type(s): Human Prescription
Master SPL: Roxane Laboratories, Inc (2014-11-24)
Oldest Current Product: 1993-10-31
License(s): ANDA

RxNORM: ORAL SOLUTION\ALPRAZOLAM
FDAOB: ORAL\CONCENTRATE\ALPRAZOLAM
SPL Active: ORAL\SOLUTION, CONCENTRATE\ALPRAZOLAM
SPL Moiety: ORAL\SOLUTION, CONCENTRATE\ALPRAZOLAM

product(s) by strength(s)

alprazolam 1 mg/ml oral solution

generic product(s)(s)

#	id	category	labeler	first marketed	active ingredient(s)	route	dose form	application	spl
1	000543068	ANDA	Roxane Laboratories, Inc	1993-10-31	ALPRAZOLAM	ORAL	SOLUTION, CONCENTRATE	ANDA074312	b945ac6f-796e-41ef-85e9-61007e4a4e9a

application(s)

#	id	title	applicant	approved	approved drug
1	ANDA074312	ALPRAZOLAM	ROXANE LABORATORIES INC	1993-10-31	ANDA074312_001

application drug(s)

#	id	category/deprecated	ingredient strength(s)	route	dose form	rld	approved	application
1	ANDA074312_001	RX	ALPRAZOLAM (1MG/ML)	ORAL	CONCENTRATE	True	1993-10-31	ALPRAZOLAM

spl(s)

#	id	title	category	type	labeler	labeler act	last update	version	product(s)
1	b945ac6f-796e-41ef-85e9-61007e4a4e9a (view SPL)		prescription	Human Prescription	Roxane Laboratories, Inc	MANUFACTURE	2014-11-24	8	000543068

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII