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Details for New Drug Application (NDA): 040377

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NDA 040377 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, Mikah Pharma, Mikah Pharma Llc, Ivax Pharms, Watson Labs, Polygen Pharms, Duramed Pharms Barr, Elite Labs, Ingenus Pharms Nj, Lannett Holdings Inc, Barr, Kvk Tech, Actavis Elizabeth, Prinston Inc, Tg United Inc, and Sun Pharm Inds Inc, and is included in eighty-five 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: 040377

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

Pharmacology for NDA: 040377

Suppliers and Packaging for NDA: 040377

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PHENTERMINE HYDROCHLORIDE
phentermine hydrochloride
TABLET;ORAL 040377 ANDA Qualitest Pharmaceuticals 0603-5192 0603-5192-16 30 TABLET in 1 BOTTLE, PLASTIC (0603-5192-16)
PHENTERMINE HYDROCHLORIDE
phentermine hydrochloride
TABLET;ORAL 040377 ANDA Qualitest Pharmaceuticals 0603-5192 0603-5192-21 100 TABLET in 1 BOTTLE, PLASTIC (0603-5192-21)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength37.5MG
Approval Date:Jan 4, 2002TE:AARLD:No


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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