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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020122
Company: HOSPIRA INC

Products on NDA 020122

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NIPENT	PENTOSTATIN	10MG/VIAL	INJECTABLE;INJECTION	Prescription	AP	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020122

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/11/1991	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
10/28/2019	SUPPL-15	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020122s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020122Orig1s015ltr.pdf
12/29/2015	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
06/20/2013	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
09/22/2009	SUPPL-10	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
05/23/2002	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
08/02/2001	SUPPL-6	Manufacturing (CMC)-Control		Label is not available on this site.
10/08/1998	SUPPL-4	Manufacturing (CMC)-Control		Label is not available on this site.
12/24/1997	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
07/19/1994	SUPPL-2	Labeling		Label is not available on this site.
09/29/1993	SUPPL-1	Efficacy-New Indication		Label is not available on this site.

Labels for NDA 020122

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/28/2019	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020122s015lbl.pdf

Therapeutic Equivalents for NDA 020122

NIPENT

INJECTABLE;INJECTION; 10MG/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
NIPENT	PENTOSTATIN	10MG/VIAL	INJECTABLE;INJECTION	Prescription	Yes	AP	020122	HOSPIRA INC
PENTOSTATIN	PENTOSTATIN	10MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	077841	WEST-WARD PHARMS INT

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