Pentostatin Injectable Solution

Brand(s): Nipent
Category(s): prescription
SPL Type(s): Human Prescription
Master SPL: Hospira, Inc. (2015-07-31)
Oldest Current Product: 2014-08-08
License(s): NDA

RxNORM: INJECTABLE SOLUTION\PENTOSTATIN
FDAOB: INJECTION\INJECTION\PENTOSTATIN\rdfq
SPL Active: INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\PENTOSTATIN
SPL Moiety: INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\PENTOSTATIN

product(s) by strength(s)

pentostatin 2 mg/ml injectable solution

original product(s)(s)

#	id	brand	category	labeler	first marketed	active ingredient(s)	route	dose form	application	spl
1	004090801	Nipent	NDA	Hospira, Inc.	1991-10-11, 2014-08-08	PENTOSTATIN	INTRAVENOUS	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	NDA020122	151c6d2e-1af1-4c13-96ec-de3228c6efb3, 674e0e6d-46ed-4868-9196-04019d667716

application(s)

#	id	title	applicant	approved	approved drug
1	ANDA077841	PENTOSTATIN	EUROHEALTH INTERNATIONAL SARL	2007-08-07	ANDA077841_001
2	ANDA203554	PENTOSTATIN	MYLAN INSTITUTIONAL LLC	2014-09-19	ANDA203554_001
3	NDA020122	NIPENT	HOSPIRA INC	1991-10-11	NDA020122_001

application drug(s)

#	id	category/deprecated	ingredient strength(s)	dose form	rld	TE	approved	application
1	ANDA077841_001	RX	PENTOSTATIN (10MG/VIAL)	INJECTION	False	AP	2007-08-07	PENTOSTATIN
2	ANDA203554_001	RX	PENTOSTATIN (10MG/VIAL)	INJECTION	False	AP	2014-09-19	PENTOSTATIN
3	NDA020122_001	RX	PENTOSTATIN (10MG/VIAL)	INJECTION	True	AP	1991-10-11	NIPENT

spl(s)

#	id	title	category	type	labeler	last update	version	product(s)
1	151c6d2e-1af1-4c13-96ec-de3228c6efb3 (view SPL)	NIPENTTM (pentostatin for injection)	prescription	Human Prescription	Hospira, Inc.	2015-07-31	1	004090801
2	674e0e6d-46ed-4868-9196-04019d667716 (view SPL)		prescription	Human Prescription	Hospira, Inc.	2015-07-30	13	004090801

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