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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 205019
Company: NUVO PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE 15MG CAPSULE;ORAL Prescription AA No No
PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE 30MG CAPSULE;ORAL Prescription AA No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/05/2014 ORIG-1 Approval STANDARD

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-2 Labeling-Package Insert

Label is not available on this site.

PHENTERMINE HYDROCHLORIDE

CAPSULE;ORAL; 15MG
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE 15MG CAPSULE;ORAL Prescription No AA 204318 AUROLIFE PHARMA LLC
PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE 15MG CAPSULE;ORAL Prescription No AA 202248 ELITE LABS
PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE 15MG CAPSULE;ORAL Prescription No AA 202858 INVAGEN PHARMS
PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE 15MG CAPSULE;ORAL Prescription No AA 040886 KVK TECH
PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE 15MG CAPSULE;ORAL Prescription No AA 087022 LANNETT
PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE 15MG CAPSULE;ORAL Prescription No AA 205019 NUVO PHARM
PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE 15MG CAPSULE;ORAL Prescription Yes AA 087190 SANDOZ

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 202858 INVAGEN PHARMS
PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE 30MG CAPSULE;ORAL Prescription No AA 204414 INVAGEN PHARMS
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 087022 LANNETT
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
PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE 30MG CAPSULE;ORAL Prescription No AA 040525 SUN PHARM INDUSTRIES
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