Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075759
Company: RISING

• REMS

Products on ANDA 075759

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075759

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
12/15/2023	SUPPL-35	Labeling-Package Insert		Label is not available on this site.
12/15/2023	SUPPL-34	Labeling-Package Insert		Label is not available on this site.
03/04/2021	SUPPL-32	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
10/08/2019	SUPPL-31	Labeling-Medication Guide, Labeling-Package Insert, 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-Package Insert, Labeling-Patient 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.

Therapeutic Equivalents for ANDA 075759

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
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