Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 014763
Company: ASTRAZENECA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CITANEST PRILOCAINE HYDROCHLORIDE 3% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No
CITANEST PRILOCAINE HYDROCHLORIDE 1% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No
CITANEST PRILOCAINE HYDROCHLORIDE 2% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No
CITANEST FORTE EPINEPHRINE BITARTRATE; PRILOCAINE HYDROCHLORIDE 0.005MG/ML;4% INJECTABLE;INJECTION Discontinued None No No
CITANEST PLAIN PRILOCAINE HYDROCHLORIDE 4% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No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
11/18/1965 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/01/2000 SUPPL-36 Manufacturing (CMC)-Control

Label is not available on this site.

05/31/1996 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

05/09/1997 SUPPL-34 Labeling

Label is not available on this site.

03/11/1987 SUPPL-26 Labeling

Label is not available on this site.

03/21/1986 SUPPL-25 Labeling

Label is not available on this site.

08/29/1986 SUPPL-24 Labeling

Label is not available on this site.

06/28/1982 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

03/22/1985 SUPPL-22 Labeling

Label is not available on this site.

03/24/1985 SUPPL-21 Labeling

Label is not available on this site.

08/31/1981 SUPPL-20 Labeling

Label is not available on this site.

07/27/1982 SUPPL-19 Labeling

Label is not available on this site.

07/27/1982 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

08/31/1981 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

05/08/1981 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

08/29/1979 SUPPL-15 Labeling

Label is not available on this site.

04/04/1979 SUPPL-14 Labeling

Label is not available on this site.

04/09/1979 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

03/03/1976 SUPPL-11 Labeling

Label is not available on this site.

03/03/1976 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

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