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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078400
Company: HIKMA FARMACEUTICA

Products on ANDA 078400

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BUTORPHANOL TARTRATE	BUTORPHANOL TARTRATE	1MG/ML	INJECTABLE;INJECTION	Prescription	AP	No	No
BUTORPHANOL TARTRATE	BUTORPHANOL TARTRATE	2MG/ML	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 078400

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/01/2009	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
01/16/2024	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
01/16/2024	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
09/15/2020	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
12/16/2016	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
12/16/2016	SUPPL-3	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 078400

BUTORPHANOL TARTRATE

INJECTABLE;INJECTION; 1MG/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BUTORPHANOL TARTRATE	BUTORPHANOL TARTRATE	1MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	078400	HIKMA FARMACEUTICA
BUTORPHANOL TARTRATE PRESERVATIVE FREE	BUTORPHANOL TARTRATE	1MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	075045	HIKMA
BUTORPHANOL TARTRATE PRESERVATIVE FREE	BUTORPHANOL TARTRATE	1MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	074626	HOSPIRA

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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