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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203191
Company: CHARTWELL MOLECULAR

Products on ANDA 203191

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CYPROHEPTADINE HYDROCHLORIDE	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP;ORAL	Prescription	AA	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 203191

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/13/2017	ORIG-1	Approval				Label is not available on this site.

Therapeutic Equivalents for ANDA 203191

CYPROHEPTADINE HYDROCHLORIDE

SYRUP;ORAL; 2MG/5ML
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CYPROHEPTADINE HYDROCHLORIDE	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP;ORAL	Prescription	No	AA	203191	CHARTWELL MOLECULAR
CYPROHEPTADINE HYDROCHLORIDE	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP;ORAL	Prescription	No	AA	209108	ELYSIUM
CYPROHEPTADINE HYDROCHLORIDE	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP;ORAL	Prescription	No	AA	040668	LYNE
CYPROHEPTADINE HYDROCHLORIDE	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP;ORAL	Prescription	No	AA	212423	QUAGEN

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