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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017751
Company: ASTRAZENECA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DURANEST ETIDOCAINE HYDROCHLORIDE 0.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE;INJECTION Discontinued None Yes No
DURANEST EPINEPHRINE; ETIDOCAINE HYDROCHLORIDE 0.005MG/ML;0.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE;INJECTION Discontinued None Yes No
DURANEST ETIDOCAINE HYDROCHLORIDE 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE;INJECTION Discontinued None Yes No
DURANEST EPINEPHRINE BITARTRATE; ETIDOCAINE HYDROCHLORIDE 0.005MG/ML;1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE;INJECTION Discontinued None Yes No
DURANEST EPINEPHRINE BITARTRATE; ETIDOCAINE HYDROCHLORIDE 0.005MG/ML;1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE;INJECTION Discontinued None Yes No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
08/30/1976 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/02/1999 SUPPL-13 Labeling

Label is not available on this site.
05/31/1996 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.
03/02/1999 SUPPL-11 Labeling

Label is not available on this site.
10/04/1990 SUPPL-10 Manufacturing (CMC)-Formulation

Label is not available on this site.
04/08/1987 SUPPL-9 Labeling

Label is not available on this site.
03/06/1986 SUPPL-8 Labeling

Label is not available on this site.
08/07/1985 SUPPL-7 Labeling

Label is not available on this site.
08/07/1985 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.
06/28/1982 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.
01/29/1987 SUPPL-4 Labeling

Label is not available on this site.
07/13/1982 SUPPL-3 Labeling

Label is not available on this site.
07/13/1982 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.
08/29/1979 SUPPL-1 Labeling

Label is not available on this site.
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