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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078400
Company: HIKMA FARMACEUTICA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BUTORPHANOL TARTRATE BUTORPHANOL TARTRATE 1MG/ML INJECTABLE;INJECTION Prescription AP No No
BUTORPHANOL TARTRATE BUTORPHANOL TARTRATE 2MG/ML INJECTABLE;INJECTION Prescription AP No 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
05/01/2009 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
09/15/2020 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

12/16/2016 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

12/16/2016 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

BUTORPHANOL TARTRATE

INJECTABLE;INJECTION; 1MG/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BUTORPHANOL TARTRATE BUTORPHANOL TARTRATE 1MG/ML INJECTABLE;INJECTION Prescription No AP 078400 HIKMA FARMACEUTICA
BUTORPHANOL TARTRATE PRESERVATIVE FREE BUTORPHANOL TARTRATE 1MG/ML INJECTABLE;INJECTION Prescription No AP 075045 HIKMA
BUTORPHANOL TARTRATE PRESERVATIVE FREE BUTORPHANOL TARTRATE 1MG/ML INJECTABLE;INJECTION Prescription No AP 074626 HOSPIRA

INJECTABLE;INJECTION; 2MG/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BUTORPHANOL TARTRATE BUTORPHANOL TARTRATE 2MG/ML INJECTABLE;INJECTION Prescription No AP 075046 HIKMA
BUTORPHANOL TARTRATE BUTORPHANOL TARTRATE 2MG/ML INJECTABLE;INJECTION Prescription No AP 078400 HIKMA FARMACEUTICA
BUTORPHANOL TARTRATE PRESERVATIVE FREE BUTORPHANOL TARTRATE 2MG/ML INJECTABLE;INJECTION Prescription No AP 075045 HIKMA
BUTORPHANOL TARTRATE PRESERVATIVE FREE BUTORPHANOL TARTRATE 2MG/ML INJECTABLE;INJECTION Prescription No AP 074626 HOSPIRA
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