Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 079138
Company: HOSPIRA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG 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
06/18/2010 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/079138s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/28/2013 SUPPL-1 Labeling-Container/Carton Labels

Label is not available on this site.

ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE

INJECTABLE;INJECTION; 4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 079138 HOSPIRA
SEPTOCAINE ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML) INJECTABLE;INJECTION Prescription Yes AP 020971 DEPROCO

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