Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075221
Company: HOSPIRA

Products on ANDA 075221

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ALFENTANIL	ALFENTANIL HYDROCHLORIDE	EQ 0.5MG BASE/ML	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075221

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/28/1999	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75221ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/28/2024	SUPPL-22	Labeling-Package Insert		Label is not available on this site.
01/26/2024	SUPPL-20	Labeling-Package Insert		Label is not available on this site.
07/16/2021	SUPPL-16	Labeling-Package Insert		Label is not available on this site.
07/16/2021	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
12/20/2002	SUPPL-2	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
11/24/1999	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 075221

ALFENTANIL

INJECTABLE;INJECTION; EQ 0.5MG BASE/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ALFENTA	ALFENTANIL HYDROCHLORIDE	EQ 0.5MG BASE/ML	INJECTABLE;INJECTION	Prescription	Yes	AP	019353	RISING
ALFENTANIL	ALFENTANIL HYDROCHLORIDE	EQ 0.5MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	075221	HOSPIRA