Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 018692
Company: HOSPIRA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MARCAINE BUPIVACAINE HYDROCHLORIDE 0.75% INJECTABLE;SPINAL 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
05/04/1984 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018692Orig1s000.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/02/2018 SUPPL-20 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018692s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/018692Orig1s020ltr.pdf
09/19/2014 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

01/30/2012 SUPPL-15 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018692s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/016964s070,018692s015,022046s004ltr.pdf
02/19/2010 SUPPL-14 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018692s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018692s014ltr.pdf
06/12/2003 SUPPL-7 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18692slr007ltr.pdf
08/21/2001 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

03/09/1999 SUPPL-3 Labeling

Label is not available on this site.

03/09/1999 SUPPL-2 Labeling

Label is not available on this site.

06/26/1987 SUPPL-1 Manufacturing (CMC)-Control

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-20 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018692s020lbl.pdf
01/30/2012 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018692s015lbl.pdf
02/19/2010 SUPPL-14 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018692s014lbl.pdf

MARCAINE

INJECTABLE;SPINAL; 0.75%
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BUPIVACAINE HYDROCHLORIDE BUPIVACAINE HYDROCHLORIDE 0.75% INJECTABLE;SPINAL Prescription No AP 209087 B BRAUN MEDICAL INC
BUPIVACAINE HYDROCHLORIDE BUPIVACAINE HYDROCHLORIDE 0.75% INJECTABLE;SPINAL Prescription No AP 207266 BAXTER HLTHCARE CORP
BUPIVACAINE HYDROCHLORIDE BUPIVACAINE HYDROCHLORIDE 0.75% INJECTABLE;SPINAL Prescription No AP 071810 HOSPIRA
BUPIVACAINE HYDROCHLORIDE BUPIVACAINE HYDROCHLORIDE 0.75% INJECTABLE;SPINAL Prescription No AP 212822 HUONS
MARCAINE BUPIVACAINE HYDROCHLORIDE 0.75% INJECTABLE;SPINAL Prescription Yes AP 018692 HOSPIRA

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English