Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090233
Company: FRESENIUS KABI USA

Products on ANDA 090233

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 090233

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/28/2009	ORIG-1	Approval			Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/anda/2009/090233Orig1s000.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/03/2023	SUPPL-4	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 090233

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