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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203436
Company: KVK TECH INC

Products on ANDA 203436

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PHENTERMINE HYDROCHLORIDE	PHENTERMINE HYDROCHLORIDE	8MG	TABLET;ORAL	Prescription	AA	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 203436

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/17/2017	ORIG-1	Approval				Label is not available on this site.

Therapeutic Equivalents for ANDA 203436

PHENTERMINE HYDROCHLORIDE

TABLET;ORAL; 8MG
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
LOMAIRA	PHENTERMINE HYDROCHLORIDE	8MG	TABLET;ORAL	Prescription	No	AA	203495	AVANTHI INC
PHENTERMINE HYDROCHLORIDE	PHENTERMINE HYDROCHLORIDE	8MG	TABLET;ORAL	Prescription	No	AA	203436	KVK TECH INC

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