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Abbreviated New Drug Application (ANDA): 075046
Company: HIKMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
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
08/12/1998 ORIG-1 Approval Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75046ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75046_Stadol.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/11/2019 SUPPL-13 Labeling-Package Insert

Label is not available on this site.

10/30/2001 SUPPL-3 Labeling

Label is not available on this site.

04/03/2001 SUPPL-2 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

10/15/1999 SUPPL-1 Labeling

Label is not available on this site.

BUTORPHANOL TARTRATE

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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