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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075759
Company: RISING
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 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
08/08/2001 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
03/04/2021 SUPPL-32 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

10/08/2019 SUPPL-31 Labeling-Package Insert, Labeling-Medication Guide, Labeling-Patient Package Insert

Label is not available on this site.

09/21/2018 SUPPL-29 Labeling-Package Insert

Label is not available on this site.

09/18/2018 SUPPL-28 REMS - PROPOSAL - D-N-A

Label is not available on this site.

03/07/2017 SUPPL-25 Labeling-Medication Guide, Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

12/16/2016 SUPPL-24 Labeling-Medication Guide, Labeling-Patient Package Insert, Labeling-Package Insert

Label is not available on this site.

12/16/2016 SUPPL-22 Labeling-Medication Guide, Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

10/17/2002 SUPPL-5 Labeling

Label is not available on this site.

08/26/2002 SUPPL-3 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

08/26/2002 SUPPL-2 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

08/26/2002 SUPPL-1 Manufacturing (CMC)-Control

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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