Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022046
Company: HOSPIRA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BUPIVACAINE HYDROCHLORIDE BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE; INJECTION Prescription None Yes No
BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 0.5%;0.0091MG/ML 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
07/13/1983 ORIG-1 Approval 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
11/02/2018 SUPPL-9 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022046s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022046Orig1s009ltr.pdf
07/30/2013 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

01/30/2012 SUPPL-4 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022046s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/016964s070,018692s015,022046s004ltr.pdf
08/31/2006 SUPPL-1 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/022046s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/022046s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/02/2018 SUPPL-9 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022046s009lbl.pdf
01/30/2012 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022046s004lbl.pdf
08/31/2006 SUPPL-1 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/022046s001lbl.pdf

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