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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075046
Company: HIKMA

Safety Labeling Change Order Letter

Products on ANDA 075046

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BUTORPHANOL TARTRATE	BUTORPHANOL TARTRATE	2MG/ML	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075046

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/12/1998	ORIG-1	Approval			Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75046ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75046_Stadol.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/10/2024	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
01/10/2024	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
10/11/2019	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
10/30/2001	SUPPL-3	Labeling		Label is not available on this site.
04/03/2001	SUPPL-2	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
10/15/1999	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 075046

BUTORPHANOL TARTRATE

INJECTABLE;INJECTION; 2MG/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BUTORPHANOL TARTRATE	BUTORPHANOL TARTRATE	2MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	075046	HIKMA
BUTORPHANOL TARTRATE	BUTORPHANOL TARTRATE	2MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	078400	HIKMA FARMACEUTICA
BUTORPHANOL TARTRATE PRESERVATIVE FREE	BUTORPHANOL TARTRATE	2MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	075045	HIKMA
BUTORPHANOL TARTRATE PRESERVATIVE FREE	BUTORPHANOL TARTRATE	2MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	074626	HOSPIRA

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