Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090968
Company: KVK TECH

Products on ANDA 090968

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BENZPHETAMINE HYDROCHLORIDE	BENZPHETAMINE HYDROCHLORIDE	50MG	TABLET;ORAL	Prescription	AA	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 090968

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/20/2010	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
01/05/2021	SUPPL-4	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 090968

BENZPHETAMINE HYDROCHLORIDE

TABLET;ORAL; 50MG
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BENZPHETAMINE HYDROCHLORIDE	BENZPHETAMINE HYDROCHLORIDE	50MG	TABLET;ORAL	Prescription	No	AA	090473	CHARTWELL
BENZPHETAMINE HYDROCHLORIDE	BENZPHETAMINE HYDROCHLORIDE	50MG	TABLET;ORAL	Prescription	No	AA	090346	EPIC PHARMA LLC
BENZPHETAMINE HYDROCHLORIDE	BENZPHETAMINE HYDROCHLORIDE	50MG	TABLET;ORAL	Prescription	No	AA	090968	KVK TECH