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Last Updated: July 10, 2020

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Details for New Drug Application (NDA): 085128

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NDA 085128 describes ADIPEX-P, which is a drug marketed by Teva and is included in two NDAs. It is available from two suppliers. Additional details are available on the ADIPEX-P profile page.

The generic ingredient in ADIPEX-P is phentermine hydrochloride. There are seventeen drug master file entries for this compound. Thirty-three suppliers are listed for this compound. Additional details are available on the phentermine hydrochloride profile page.
Summary for 085128
Ingredient:phentermine hydrochloride
Formulation / Manufacturing:see details
Pharmacology for NDA: 085128
Suppliers and Packaging for NDA: 085128
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ADIPEX-P phentermine hydrochloride TABLET;ORAL 085128 ANDA PD-Rx Pharmaceuticals, Inc. 55289-379 55289-379-30 30 TABLET in 1 BOTTLE, PLASTIC (55289-379-30)
ADIPEX-P phentermine hydrochloride TABLET;ORAL 085128 ANDA Teva Pharmaceuticals USA, Inc. 57844-009 57844-009-01 100 TABLET in 1 BOTTLE (57844-009-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength37.5MG
Approval Date:Approved Prior to Jan 1, 1982TE:AARLD:No

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Serving leading biopharmaceutical companies globally:

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