Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210257
Company: FRESENIUS KABI USA

Products on ANDA 210257

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 210257

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/25/2019	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 210257

DICYCLOMINE HYDROCHLORIDE

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

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BENTYL	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE;INJECTION	Prescription	Yes	AP	008370	ABBVIE
BENTYL PRESERVATIVE FREE	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE;INJECTION	Prescription	Yes	AP	008370	ABBVIE
DICYCLOMINE HYDROCHLORIDE	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	208353	AM REGENT
DICYCLOMINE HYDROCHLORIDE	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	210979	FOSUN PHARMA
DICYCLOMINE HYDROCHLORIDE	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	210257	FRESENIUS KABI USA
DICYCLOMINE HYDROCHLORIDE	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	206468	NEXUS
DICYCLOMINE HYDROCHLORIDE	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	207076	SLATE RUN PHARMA
DICYCLOMINE HYDROCHLORIDE (PRESERVATIVE FREE)	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	040465	HIKMA