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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 209442
Company: HIKMA

Products on ANDA 209442

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 209442

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/14/2021	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 209442

BENZTROPINE MESYLATE

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

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BENZTROPINE MESYLATE	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	090233	FRESENIUS KABI USA
BENZTROPINE MESYLATE	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	209442	HIKMA
BENZTROPINE MESYLATE	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	090287	HIKMA FARMACEUTICA
BENZTROPINE MESYLATE	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	091525	NAVINTA LLC

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