Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 071168
Company: HOSPIRA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE 0.5%;0.005MG/ML INJECTABLE;INJECTION Prescription AP No 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
06/16/1988 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/16/2020 SUPPL-38 Labeling-Package Insert

Label is not available on this site.

07/16/2020 SUPPL-31 Labeling-Package Insert

Label is not available on this site.

07/16/2020 SUPPL-29 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

02/19/2010 SUPPL-20 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/071168s020lbl.pdf
12/20/2002 SUPPL-10 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

11/22/1999 SUPPL-9 Labeling

Label is not available on this site.

07/29/1997 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

09/26/1997 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

10/03/1990 SUPPL-5 Labeling

Label is not available on this site.

05/04/1990 SUPPL-4 Labeling

Label is not available on this site.

02/21/1991 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

02/21/1991 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

02/21/1991 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/19/2010 SUPPL-20 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/071168s020lbl.pdf

BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE

INJECTABLE;INJECTION; 0.5%;0.005MG/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE 0.5%;0.005MG/ML INJECTABLE;INJECTION Prescription No AP 071168 HOSPIRA
BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE 0.5%;0.005MG/ML INJECTABLE;INJECTION Prescription No AP 071170 HOSPIRA

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