Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 009435
Company: FRESENIUS KABI USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NESACAINE CHLOROPROCAINE HYDROCHLORIDE 1% INJECTABLE;INJECTION Prescription None Yes Yes
NESACAINE CHLOROPROCAINE HYDROCHLORIDE 2% INJECTABLE;INJECTION Prescription AP Yes No
NESACAINE-MPF CHLOROPROCAINE HYDROCHLORIDE 2% INJECTABLE;INJECTION Discontinued None No No
NESACAINE-MPF CHLOROPROCAINE HYDROCHLORIDE 3% INJECTABLE;INJECTION Discontinued None No No
NESACAINE-MPF CHLOROPROCAINE HYDROCHLORIDE 2% INJECTABLE;INJECTION Prescription AP Yes Yes
NESACAINE-MPF CHLOROPROCAINE HYDROCHLORIDE 3% INJECTABLE;INJECTION Prescription AP Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
03/11/1955 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
11/02/2018 SUPPL-44 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/009435s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/009435Orig1s044Ltr.pdf
02/16/2013 SUPPL-40 Manufacturing (CMC)

Label is not available on this site.

02/19/2010 SUPPL-36 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/009435s035s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/009435s035s036ltr.pdf
02/19/2010 SUPPL-35 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/009435s035s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/009435s035s036ltr.pdf
06/21/2004 SUPPL-34 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/09435slr034_nesacaine_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/09435slr034ltr.pdf
02/15/2002 SUPPL-33 Manufacturing (CMC)-Control

Label is not available on this site.

11/10/2000 SUPPL-32 Labeling

Label is not available on this site.

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

Label is not available on this site.

05/02/1996 SUPPL-30 Manufacturing (CMC)-Formulation

Label is not available on this site.

04/05/1995 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

04/13/1993 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

08/27/1990 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

03/05/1990 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

08/26/1988 SUPPL-25 Labeling

Label is not available on this site.

07/30/1987 SUPPL-24 Labeling

Label is not available on this site.

07/30/1987 SUPPL-23 Labeling

Label is not available on this site.

07/30/1987 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

08/06/1986 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

11/14/1986 SUPPL-20 Labeling

Label is not available on this site.

02/12/1982 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

02/12/1982 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

07/16/1985 SUPPL-16 Labeling

Label is not available on this site.

07/16/1985 SUPPL-15 Manufacturing (CMC)-Formulation

Label is not available on this site.

07/16/1985 SUPPL-14 Manufacturing (CMC)-Formulation

Label is not available on this site.

02/23/1981 SUPPL-13 Labeling

Label is not available on this site.

02/23/1981 SUPPL-12 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/13/1979 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

02/27/1979 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

11/06/1980 SUPPL-8 Labeling

Label is not available on this site.

11/15/1974 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

03/16/1976 SUPPL-5 Labeling

Label is not available on this site.

03/16/1976 SUPPL-4 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/02/2018 SUPPL-44 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/009435s044lbl.pdf
02/19/2010 SUPPL-36 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/009435s035s036lbl.pdf
02/19/2010 SUPPL-35 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/009435s035s036lbl.pdf
06/21/2004 SUPPL-34 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/09435slr034_nesacaine_lbl.pdf

NESACAINE

INJECTABLE;INJECTION; 2%
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CHLOROPROCAINE HYDROCHLORIDE CHLOROPROCAINE HYDROCHLORIDE 2% INJECTABLE;INJECTION Prescription No AP 087447 HOSPIRA
CHLOROPROCAINE HYDROCHLORIDE CHLOROPROCAINE HYDROCHLORIDE 2% INJECTABLE;INJECTION Prescription No AP 040273 WEST-WARD PHARMS INT
NESACAINE CHLOROPROCAINE HYDROCHLORIDE 2% INJECTABLE;INJECTION Prescription Yes AP 009435 FRESENIUS KABI USA
NESACAINE-MPF CHLOROPROCAINE HYDROCHLORIDE 2% INJECTABLE;INJECTION Prescription Yes AP 009435 FRESENIUS KABI USA

NESACAINE-MPF

INJECTABLE;INJECTION; 2%
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CHLOROPROCAINE HYDROCHLORIDE CHLOROPROCAINE HYDROCHLORIDE 2% INJECTABLE;INJECTION Prescription No AP 087447 HOSPIRA
CHLOROPROCAINE HYDROCHLORIDE CHLOROPROCAINE HYDROCHLORIDE 2% INJECTABLE;INJECTION Prescription No AP 040273 WEST-WARD PHARMS INT
NESACAINE CHLOROPROCAINE HYDROCHLORIDE 2% INJECTABLE;INJECTION Prescription Yes AP 009435 FRESENIUS KABI USA
NESACAINE-MPF CHLOROPROCAINE HYDROCHLORIDE 2% INJECTABLE;INJECTION Prescription Yes AP 009435 FRESENIUS KABI USA

INJECTABLE;INJECTION; 3%
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CHLOROPROCAINE HYDROCHLORIDE CHLOROPROCAINE HYDROCHLORIDE 3% INJECTABLE;INJECTION Prescription No AP 087446 HOSPIRA
CHLOROPROCAINE HYDROCHLORIDE CHLOROPROCAINE HYDROCHLORIDE 3% INJECTABLE;INJECTION Prescription No AP 040273 WEST-WARD PHARMS INT
NESACAINE-MPF CHLOROPROCAINE HYDROCHLORIDE 3% INJECTABLE;INJECTION Prescription Yes AP 009435 FRESENIUS KABI USA

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