Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040875
Company: KVK TECH

Products on ANDA 040875

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PHENTERMINE HYDROCHLORIDE	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE;ORAL	Prescription	AA	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040875

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/21/2008	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
05/31/2017	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
12/06/2012	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 040875

PHENTERMINE HYDROCHLORIDE

CAPSULE;ORAL; 30MG
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
PHENTERMINE HYDROCHLORIDE	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE;ORAL	Prescription	No	AA	204318	AUROLIFE PHARMA LLC
PHENTERMINE HYDROCHLORIDE	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE;ORAL	Prescription	No	AA	202248	ELITE LABS
PHENTERMINE HYDROCHLORIDE	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE;ORAL	Prescription	No	AA	040875	KVK TECH
PHENTERMINE HYDROCHLORIDE	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE;ORAL	Prescription	No	AA	040886	KVK TECH
PHENTERMINE HYDROCHLORIDE	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE;ORAL	Prescription	No	AA	205019	NUVO PHARM
PHENTERMINE HYDROCHLORIDE	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE;ORAL	Prescription	Yes	AA	086945	SANDOZ
PHENTERMINE HYDROCHLORIDE	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE;ORAL	Prescription	Yes	AA	087190	SANDOZ