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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 073399
Company: GENUS

Products on ANDA 073399

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	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 073399

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/30/1994	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
08/30/2001	SUPPL-17	Manufacturing (CMC)-Facility		Label is not available on this site.
07/07/2000	SUPPL-16	Manufacturing (CMC)-Facility		Label is not available on this site.
12/09/1999	SUPPL-15	Manufacturing (CMC)-Packaging		Label is not available on this site.
10/30/1997	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
05/05/1997	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
04/15/1998	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
10/30/1997	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
10/02/1995	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
10/02/1995	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
10/02/1995	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
10/02/1995	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
10/02/1995	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
10/02/1995	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
06/29/1995	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
06/29/1995	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
05/04/1995	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
05/04/1995	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 073399

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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