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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019264
Company: FRESENIUS KABI USA

Products on NDA 019264

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PENTAM	PENTAMIDINE ISETHIONATE	300MG/VIAL	INJECTABLE;INJECTION	Prescription	AP	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019264

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/16/1984	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY; Orphan		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/08/2014	SUPPL-32	Manufacturing (CMC)		Label is not available on this site.
02/16/2013	SUPPL-31	Manufacturing (CMC)		Label is not available on this site.
05/24/2002	SUPPL-23	Manufacturing (CMC)		Label is not available on this site.
10/24/1997	SUPPL-21	Labeling		Label is not available on this site.
02/26/1997	SUPPL-19	Labeling		Label is not available on this site.
03/18/1996	SUPPL-18	Labeling		Label is not available on this site.
06/08/1994	SUPPL-17	Manufacturing (CMC)-Control		Label is not available on this site.
05/31/1994	SUPPL-16	Manufacturing (CMC)-Control		Label is not available on this site.
08/27/1996	SUPPL-15	Labeling		Label is not available on this site.
08/16/1989	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
02/09/1993	SUPPL-13	Labeling		Label is not available on this site.
11/14/1988	SUPPL-12	Manufacturing (CMC)-Packaging		Label is not available on this site.
06/12/1987	SUPPL-8	Manufacturing (CMC)-Control		Label is not available on this site.
10/24/1986	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
10/24/1986	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
10/24/1986	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
04/09/1987	SUPPL-4	Labeling		Label is not available on this site.
06/10/1987	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
08/06/1985	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.

Therapeutic Equivalents for NDA 019264

PENTAM

INJECTABLE;INJECTION; 300MG/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
PENTAM	PENTAMIDINE ISETHIONATE	300MG/VIAL	INJECTABLE;INJECTION	Prescription	Yes	AP	019264	FRESENIUS KABI USA
PENTAMIDINE ISETHIONATE	PENTAMIDINE ISETHIONATE	300MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	213806	AVET LIFESCIENCES
PENTAMIDINE ISETHIONATE	PENTAMIDINE ISETHIONATE	300MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	206666	PAI HOLDINGS

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