Details for New Drug Application (NDA): 204318
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NDA 204318 describes PHENTERMINE HYDROCHLORIDE, which is a drug marketed by Abc Holding, Able, Aurolife Pharma Llc, Barr, Camall, Chartwell Rx, Duramed Pharms Barr, Elite Labs, Elite Labs Inc, Invagen Pharms, Ivax Pharms, Kvk Tech, Lannett, Lannett Co Inc, Nuvo Pharm, Sandoz, Sun Pharm Industries, Teva, Tg United Inc, Upsher Smith Labs, Usl Pharma, Vitarine, Watson Labs, Zydus Pharms, Actavis Elizabeth, Aurobindo Pharma Ltd, Kvk Tech Inc, Merro Pharm Usa, Novast Labs, Prinston Inc, Sandoz Inc, Sun Pharm Inds Inc, and Actavis Labs Fl Inc, and is included in eighty-eight NDAs. It is available from thirty-one suppliers. Additional details are available on the PHENTERMINE HYDROCHLORIDE profile page.
The generic ingredient in PHENTERMINE HYDROCHLORIDE is phentermine hydrochloride; topiramate. There are seventeen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the phentermine hydrochloride; topiramate profile page.
The generic ingredient in PHENTERMINE HYDROCHLORIDE is phentermine hydrochloride; topiramate. There are seventeen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the phentermine hydrochloride; topiramate profile page.
Summary for 204318
| Tradename: | PHENTERMINE HYDROCHLORIDE |
| Applicant: | Aurolife Pharma Llc |
| Ingredient: | phentermine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 204318
| Physiological Effect | Appetite Suppression Increased Sympathetic Activity |
Suppliers and Packaging for NDA: 204318
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PHENTERMINE HYDROCHLORIDE | phentermine hydrochloride | CAPSULE;ORAL | 204318 | ANDA | Aurolife Pharma, LLC | 13107-105 | 13107-105-01 | 100 CAPSULE in 1 BOTTLE (13107-105-01) |
| PHENTERMINE HYDROCHLORIDE | phentermine hydrochloride | CAPSULE;ORAL | 204318 | ANDA | Aurolife Pharma, LLC | 13107-105 | 13107-105-30 | 30 CAPSULE in 1 BOTTLE (13107-105-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 15MG | ||||
| Approval Date: | Nov 9, 2016 | TE: | AA | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 30MG | ||||
| Approval Date: | Nov 9, 2016 | TE: | AA | RLD: | No | ||||
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