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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074884
Company: NEW HEIGHTSRX

Products on ANDA 074884

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CLEMASTINE FUMARATE	CLEMASTINE FUMARATE	EQ 0.5MG BASE/5ML	SYRUP;ORAL	Prescription	AA	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 074884

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/17/1997	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
05/31/2002	SUPPL-2	Labeling		Label is not available on this site.
05/31/2002	SUPPL-1	Manufacturing (CMC)-Packaging		Label is not available on this site.

Therapeutic Equivalents for ANDA 074884

CLEMASTINE FUMARATE

SYRUP;ORAL; EQ 0.5MG BASE/5ML
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CLEMASTINE FUMARATE	CLEMASTINE FUMARATE	EQ 0.5MG BASE/5ML	SYRUP;ORAL	Prescription	No	AA	073399	GENUS
CLEMASTINE FUMARATE	CLEMASTINE FUMARATE	EQ 0.5MG BASE/5ML	SYRUP;ORAL	Prescription	No	AA	074884	NEW HEIGHTSRX

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