Details for New Drug Application (NDA): 209151
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NDA 209151 describes ANAGRELIDE HYDROCHLORIDE, which is a drug marketed by Barr, Chartwell Rx, Impax Labs, Ivax Sub Teva Pharms, Natco Pharma Usa, Rising, Roxane, Torrent, and Watson Labs, and is included in nine NDAs. It is available from three suppliers. Additional details are available on the ANAGRELIDE HYDROCHLORIDE profile page.
The generic ingredient in ANAGRELIDE HYDROCHLORIDE is anagrelide hydrochloride. There are eight drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the anagrelide hydrochloride profile page.
The generic ingredient in ANAGRELIDE HYDROCHLORIDE is anagrelide hydrochloride. There are eight drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the anagrelide hydrochloride profile page.
Summary for 209151
| Tradename: | ANAGRELIDE HYDROCHLORIDE |
| Applicant: | Torrent |
| Ingredient: | anagrelide hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 209151
| Mechanism of Action | Phosphodiesterase 3 Inhibitors |
| Physiological Effect | Decreased Platelet Production |
Suppliers and Packaging for NDA: 209151
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ANAGRELIDE HYDROCHLORIDE | anagrelide hydrochloride | CAPSULE;ORAL | 209151 | ANDA | Torrent Pharmaceuticals Limited | 13668-453 | 13668-453-01 | 100 CAPSULE in 1 BOTTLE (13668-453-01) |
| ANAGRELIDE HYDROCHLORIDE | anagrelide hydrochloride | CAPSULE;ORAL | 209151 | ANDA | Torrent Pharmaceuticals Limited | 13668-453 | 13668-453-30 | 30 CAPSULE in 1 BOTTLE (13668-453-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 0.5MG BASE | ||||
| Approval Date: | Jun 30, 2017 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 1MG BASE | ||||
| Approval Date: | Jun 30, 2017 | TE: | AB | RLD: | No | ||||
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