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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075824
Company: HIKMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BUTORPHANOL TARTRATE BUTORPHANOL TARTRATE 1MG/SPRAY SPRAY, METERED;NASAL Prescription AB 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
03/12/2002 ORIG-1 Approval Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75824AP.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/075824.PDF
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/04/2021 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

10/07/2019 SUPPL-13 Labeling-Package Insert

Label is not available on this site.

09/21/2018 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

09/18/2018 SUPPL-11 REMS - PROPOSAL - D-N-A

Label is not available on this site.

03/23/2017 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

12/16/2016 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

BUTORPHANOL TARTRATE

SPRAY, METERED;NASAL; 1MG/SPRAY
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BUTORPHANOL TARTRATE BUTORPHANOL TARTRATE 1MG/SPRAY SPRAY, METERED;NASAL Prescription No AB 075499 APOTEX INC
BUTORPHANOL TARTRATE BUTORPHANOL TARTRATE 1MG/SPRAY SPRAY, METERED;NASAL Prescription No AB 075824 HIKMA
BUTORPHANOL TARTRATE BUTORPHANOL TARTRATE 1MG/SPRAY SPRAY, METERED;NASAL Prescription No AB 075759 RISING
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