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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074901
Company: HIKMA

Products on ANDA 074901

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ATRACURIUM BESYLATE	ATRACURIUM BESYLATE	10MG/ML	INJECTABLE;INJECTION	Prescription	AP	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 074901

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/18/1997	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
07/26/2018	SUPPL-20	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
11/23/2010	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
03/26/2001	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.
06/27/2002	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Therapeutic Equivalents for ANDA 074901

ATRACURIUM BESYLATE

INJECTABLE;INJECTION; 10MG/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ATRACURIUM BESYLATE	ATRACURIUM BESYLATE	10MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	074901	HIKMA
ATRACURIUM BESYLATE	ATRACURIUM BESYLATE	10MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	090761	HOSPIRA INC
ATRACURIUM BESYLATE	ATRACURIUM BESYLATE	10MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	091489	MEITHEAL
ATRACURIUM BESYLATE PRESERVATIVE FREE	ATRACURIUM BESYLATE	10MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	074900	HIKMA
ATRACURIUM BESYLATE PRESERVATIVE FREE	ATRACURIUM BESYLATE	10MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	090782	HOSPIRA INC
ATRACURIUM BESYLATE PRESERVATIVE FREE	ATRACURIUM BESYLATE	10MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	091488	MEITHEAL

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