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Generated: January 17, 2019

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Details for New Drug Application (NDA): 203495

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NDA 203495 describes LOMAIRA, which is a drug marketed by Avanthi Inc and is included in one NDA. It is available from one supplier. Additional details are available on the LOMAIRA profile page.

The generic ingredient in LOMAIRA is phentermine hydrochloride. There are seventeen drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the phentermine hydrochloride profile page.
Summary for 203495
Applicant:Avanthi Inc
Ingredient:phentermine hydrochloride
Formulation / Manufacturing:see details
Pharmacology for NDA: 203495
Suppliers and Packaging for NDA: 203495
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LOMAIRA phentermine hydrochloride TABLET;ORAL 203495 ANDA KVK-TECH, INC. 10702-001 10702-001-03 30 TABLET in 1 BOTTLE (10702-001-03)
LOMAIRA phentermine hydrochloride TABLET;ORAL 203495 ANDA KVK-TECH, INC. 10702-001 10702-001-06 60 TABLET in 1 BOTTLE (10702-001-06)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength8MG
Approval Date:Sep 12, 2016TE:AARLD:No

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