Details for New Drug Application (NDA): 204982
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NDA 204982 describes PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE, which is a drug marketed by Actavis Labs Fl Inc and Dr Reddys Labs Sa and is included in two NDAs. It is available from two suppliers. Additional details are available on the PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE profile page.
The generic ingredient in PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE is phentermine hydrochloride; topiramate. There are seventeen drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the phentermine hydrochloride; topiramate profile page.
The generic ingredient in PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE is phentermine hydrochloride; topiramate. There are seventeen drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the phentermine hydrochloride; topiramate profile page.
Summary for 204982
| Tradename: | PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE |
| Applicant: | Actavis Labs Fl Inc |
| Ingredient: | phentermine hydrochloride; topiramate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 204982
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE | phentermine hydrochloride; topiramate | CAPSULE, EXTENDED RELEASE;ORAL | 204982 | ANDA | Teva Pharmaceuticals, Inc. | 0480-2299 | 0480-2299-56 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0480-2299-56) |
| PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE | phentermine hydrochloride; topiramate | CAPSULE, EXTENDED RELEASE;ORAL | 204982 | ANDA | Teva Pharmaceuticals, Inc. | 0480-3295 | 0480-3295-56 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0480-3295-56) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | EQ 3.75MG BASE;23MG | ||||
| Approval Date: | Jun 25, 2024 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | EQ 7.5MG BASE;46MG | ||||
| Approval Date: | Jun 25, 2024 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | EQ 11.25MG BASE;69MG | ||||
| Approval Date: | Jun 25, 2024 | TE: | AB | RLD: | No | ||||
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