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Generated: December 15, 2017

DrugPatentWatch Database Preview

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-seven suppliers are listed for this compound. Additional details are available on the phentermine hydrochloride profile page.

Summary for 203495

Tradename:1
Applicant:1
Ingredient:1
Patents:0
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 10702-001-09 90 TABLET in 1 BOTTLE (10702-001-09)

Summary for product number 001

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


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Serving leading biopharmaceutical companies globally:

McKesson
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Julphar
Dow
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Fuji

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