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-five suppliers are listed for this compound. Additional details are available on the phentermine hydrochloride profile page.
The generic ingredient in ADIPEX-P 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 085128
| Tradename: | ADIPEX-P |
| Applicant: | Teva |
| Ingredient: | phentermine hydrochloride |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 085128
| Physiological Effect | Appetite Suppression Increased Sympathetic Activity |
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 | Teva Pharmaceuticals USA, Inc. | 57844-140 | 57844-140-01 | 100 TABLET in 1 BOTTLE (57844-140-01) |
| ADIPEX-P | phentermine hydrochloride | TABLET;ORAL | 085128 | ANDA | Teva Pharmaceuticals USA, Inc. | 57844-140 | 57844-140-56 | 30 TABLET in 1 BOTTLE (57844-140-56) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 37.5MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AA | RLD: | Yes | ||||
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