Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 012250
Company: HOSPIRA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CARBOCAINE MEPIVACAINE HYDROCHLORIDE 1% INJECTABLE;INJECTION Prescription AP Yes Yes
CARBOCAINE MEPIVACAINE HYDROCHLORIDE 2% INJECTABLE;INJECTION Prescription AP Yes Yes
CARBOCAINE MEPIVACAINE HYDROCHLORIDE 1.5% 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
05/17/1960 ORIG-1 Approval Type 3 - New Dosage Form 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-37 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/012250s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/012250Orig1s037Ltr.pdf
02/19/2010 SUPPL-33 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/012250s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/012250s033ltr.pdf
09/28/2005 SUPPL-28 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/012250s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/012250s028ltr.pdf
01/31/2001 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

03/11/1999 SUPPL-22 Labeling

Label is not available on this site.

05/21/1991 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

04/27/1999 SUPPL-19 Labeling

Label is not available on this site.

03/15/1985 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

03/30/1984 SUPPL-17 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/29/1987 SUPPL-16 Labeling

Label is not available on this site.

08/21/1981 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

10/03/1980 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

06/15/1978 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

06/26/1979 SUPPL-12 Labeling

Label is not available on this site.

10/06/1976 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

10/28/1975 SUPPL-8 Labeling

Label is not available on this site.

04/15/1974 SUPPL-7 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-37 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/012250s037lbl.pdf
02/19/2010 SUPPL-33 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/012250s033lbl.pdf
09/28/2005 SUPPL-28 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/012250s028lbl.pdf

CARBOCAINE

INJECTABLE;INJECTION; 1%
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CARBOCAINE MEPIVACAINE HYDROCHLORIDE 1% INJECTABLE;INJECTION Prescription Yes AP 012250 HOSPIRA
POLOCAINE MEPIVACAINE HYDROCHLORIDE 1% INJECTABLE;INJECTION Prescription No AP 089407 FRESENIUS KABI USA
POLOCAINE-MPF MEPIVACAINE HYDROCHLORIDE 1% INJECTABLE;INJECTION Prescription No AP 089406 FRESENIUS KABI USA

INJECTABLE;INJECTION; 2%
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CARBOCAINE MEPIVACAINE HYDROCHLORIDE 2% INJECTABLE;INJECTION Prescription Yes AP 012250 HOSPIRA
POLOCAINE MEPIVACAINE HYDROCHLORIDE 2% INJECTABLE;INJECTION Prescription No AP 089410 FRESENIUS KABI USA
POLOCAINE-MPF MEPIVACAINE HYDROCHLORIDE 2% INJECTABLE;INJECTION Prescription No AP 089409 FRESENIUS KABI USA

INJECTABLE;INJECTION; 1.5%
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CARBOCAINE MEPIVACAINE HYDROCHLORIDE 1.5% INJECTABLE;INJECTION Prescription Yes AP 012250 HOSPIRA
POLOCAINE-MPF MEPIVACAINE HYDROCHLORIDE 1.5% INJECTABLE;INJECTION Prescription No AP 089408 FRESENIUS KABI USA

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