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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074626
Company: HOSPIRA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BUTORPHANOL TARTRATE PRESERVATIVE FREE BUTORPHANOL TARTRATE 1MG/ML INJECTABLE;INJECTION Prescription AP No Yes
BUTORPHANOL TARTRATE PRESERVATIVE FREE BUTORPHANOL TARTRATE 2MG/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
01/23/1997 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
04/04/2024 SUPPL-38 Labeling-Package Insert

Label is not available on this site.
12/19/2023 SUPPL-35 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.
10/11/2019 SUPPL-30 Labeling-Package Insert

Label is not available on this site.
12/16/2016 SUPPL-28 Labeling-Package Insert

Label is not available on this site.
12/16/2016 SUPPL-27 Labeling-Package Insert

Label is not available on this site.
09/18/2002 SUPPL-15 Labeling

Label is not available on this site.
10/25/2002 SUPPL-14 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.
05/08/2003 SUPPL-13 Labeling

Label is not available on this site.
09/07/2001 SUPPL-12 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.
02/14/2001 SUPPL-11 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.
03/22/2001 SUPPL-10 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.
03/22/2001 SUPPL-9 Manufacturing (CMC)-Packaging

Label is not available on this site.
03/01/2000 SUPPL-8 Manufacturing (CMC)-Facility

Label is not available on this site.
10/22/1999 SUPPL-7 Labeling

Label is not available on this site.
03/01/2000 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.
03/01/2000 SUPPL-5 Labeling

Label is not available on this site.
03/01/2000 SUPPL-4 Manufacturing (CMC)-Facility

Label is not available on this site.
01/07/2000 SUPPL-3 Labeling

Label is not available on this site.
01/07/2000 SUPPL-2 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.
11/23/1998 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

BUTORPHANOL TARTRATE PRESERVATIVE FREE

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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