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Serving 500+ biopharmaceutical companies globally:

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Generated: July 29, 2017

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Details for New Drug Application (NDA): 090591

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NDA 090591 describes PHENTERMINE HYDROCHLORIDE, which is a drug marketed by Vitarine, Able, Usl Pharma, Sandoz Inc, Tg United Labs, Sandoz, Ken Lifescience, Abc Holding, Teva, Invagen Pharms, Aurolife Pharma Llc, Lannett, Sun Pharm Inds, Camall, Elite Labs Inc, Ivax Pharms, Upsher-smith Labs, Kvk Tech Inc, Watson Labs, Polygen Pharms, Duramed Pharms Barr, Elite Labs, Ingenus Pharms Nj, Mikah Pharma, Lannett Holdings Inc, Zydus Pharms Usa Inc, Barr, Kvk Tech, Actavis Elizabeth, Prinston Inc, Tg United Inc, and Sun Pharm Inds Inc, and is included in eighty-seven NDAs. It is available from forty-five suppliers. Additional details are available on the PHENTERMINE HYDROCHLORIDE profile page.

The generic ingredient in PHENTERMINE HYDROCHLORIDE 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 NDA: 090591

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 090591

Suppliers and Packaging for NDA: 090591

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PHENTERMINE HYDROCHLORIDE
phentermine hydrochloride
CAPSULE;ORAL 090591 ANDA Teva Pharmaceuticals USA Inc 0093-2109 0093-2109-01 100 CAPSULE in 1 BOTTLE (0093-2109-01)
PHENTERMINE HYDROCHLORIDE
phentermine hydrochloride
CAPSULE;ORAL 090591 ANDA Teva Pharmaceuticals USA Inc 0093-2110 0093-2110-01 100 CAPSULE in 1 BOTTLE (0093-2110-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength15MG
Approval Date:Mar 18, 2010TE:AARLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength30MG
Approval Date:Mar 18, 2010TE:AARLD:No


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Serving 500+ biopharmaceutical companies globally:

Healthtrust
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Deloitte
Dow
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Mallinckrodt
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Express Scripts

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