Details for New Drug Application (NDA): 020333
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NDA 020333 describes AGRYLIN, which is a drug marketed by Takeda Pharms Usa and is included in one NDA. It is available from one supplier. Additional details are available on the AGRYLIN profile page.
The generic ingredient in AGRYLIN 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 AGRYLIN 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 020333
| Tradename: | AGRYLIN |
| Applicant: | Takeda Pharms Usa |
| Ingredient: | anagrelide hydrochloride |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 020333
| Mechanism of Action | Phosphodiesterase 3 Inhibitors |
| Physiological Effect | Decreased Platelet Production |
Suppliers and Packaging for NDA: 020333
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AGRYLIN | anagrelide hydrochloride | CAPSULE;ORAL | 020333 | NDA | Takeda Pharmaceuticals America, Inc. | 54092-063 | 54092-063-01 | 100 CAPSULE in 1 BOTTLE (54092-063-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 0.5MG BASE | ||||
| Approval Date: | Mar 14, 1997 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Mar 14, 1997 | TE: | RLD: | Yes | |||||
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