Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075824
Company: HIKMA

• REMS

Products on ANDA 075824

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 075824

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.

Therapeutic Equivalents for ANDA 075824

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