Drugs@FDA: FDA Approved Drug Products

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

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 AKORN
ALFENTANIL ALFENTANIL HYDROCHLORIDE EQ 0.5MG BASE/ML INJECTABLE;INJECTION Prescription No AP 075221 HOSPIRA

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