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 two suppliers. 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. Thirty-five suppliers are listed for this compound. Additional details are available on the phentermine hydrochloride profile page.
The generic ingredient in LOMAIRA is phentermine hydrochloride. There are seventeen drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the phentermine hydrochloride profile page.
Summary for 203495
| Tradename: | LOMAIRA |
| Applicant: | Avanthi Inc |
| Ingredient: | phentermine hydrochloride |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 203495
| Physiological Effect | Appetite Suppression Increased Sympathetic Activity |
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: | RX | Dosage: | TABLET;ORAL | Strength | 8MG | ||||
| Approval Date: | Sep 12, 2016 | TE: | AA | RLD: | No | ||||
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