Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075499
Company: APOTEX INC
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
12/04/2002 ORIG-1 Approval Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/075499_ORIGINAL APPROVAL_PACKAGE.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/09/2019 SUPPL-26 Labeling-Medication Guide, Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

09/20/2018 SUPPL-25 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

09/18/2018 SUPPL-24 REMS - PROPOSAL - D-N-A

Label is not available on this site.

03/23/2017 SUPPL-22 Labeling-Package Insert

Label is not available on this site.

12/16/2016 SUPPL-20 Labeling-Package Insert

Label is not available on this site.

12/16/2016 SUPPL-18 Labeling-Package Insert

Label is not available on this site.

05/06/2009 SUPPL-11 Labeling

Label is not available on this site.

03/19/2007 SUPPL-7 Labeling

Label is not available on this site.

04/28/2004 SUPPL-2 Labeling

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 MYLAN

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