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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040169
Company: GENERICS

Products on ANDA 040169

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DICYCLOMINE HYDROCHLORIDE	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP;ORAL	Prescription	AA	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040169

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/24/2005	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
12/27/2017	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
08/28/2008	SUPPL-2	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 040169

DICYCLOMINE HYDROCHLORIDE

SYRUP;ORAL; 10MG/5ML
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DICYCLOMINE HYDROCHLORIDE	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP;ORAL	Prescription	No	AA	040169	GENERICS
DICYCLOMINE HYDROCHLORIDE	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP;ORAL	Prescription	No	AA	212286	HIKMA
DICYCLOMINE HYDROCHLORIDE	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP;ORAL	Prescription	No	AA	214721	NOVITIUM PHARMA

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