Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075499
Company: APOTEX

• REMS

Products on ANDA 075499

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075499

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
10/31/2024	SUPPL-36	REMS - MODIFIED - D-N-A		Label is not available on this site.
12/15/2023	SUPPL-34	Labeling-Package Insert		Label is not available on this site.
12/15/2023	SUPPL-33	Labeling-Package Insert		Label is not available on this site.
03/05/2021	SUPPL-28	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
10/09/2019	SUPPL-26	Labeling-Package Insert, Labeling-Patient Package Insert, Labeling-Medication Guide		Label is not available on this site.
09/20/2018	SUPPL-25	Labeling-Package Insert, Labeling-Medication Guide		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.

Therapeutic Equivalents for ANDA 075499

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