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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040465
Company: HIKMA

Products on ANDA 040465

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040465

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/30/2003	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
05/29/2018	SUPPL-8	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
05/29/2018	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
05/10/2012	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
10/05/2007	SUPPL-2	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 040465

DICYCLOMINE HYDROCHLORIDE (PRESERVATIVE FREE)

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

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
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	207076	SLATE RUN PHARMA
DICYCLOMINE HYDROCHLORIDE	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	214332	SOMERSET THERAPS LLC
DICYCLOMINE HYDROCHLORIDE	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	214333	SOMERSET THERAPS LLC
DICYCLOMINE HYDROCHLORIDE (PRESERVATIVE FREE)	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	040465	HIKMA

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