Details for New Drug Application (NDA): 205523
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NDA 205523 describes ALMOTRIPTAN MALATE, which is a drug marketed by Ajanta Pharma Ltd, Mylan, and Teva Pharms Usa, and is included in three NDAs. It is available from three suppliers. Additional details are available on the ALMOTRIPTAN MALATE profile page.
The generic ingredient in ALMOTRIPTAN MALATE is almotriptan malate. There are six drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the almotriptan malate profile page.
The generic ingredient in ALMOTRIPTAN MALATE is almotriptan malate. There are six drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the almotriptan malate profile page.
Summary for 205523
| Tradename: | ALMOTRIPTAN MALATE |
| Applicant: | Ajanta Pharma Ltd |
| Ingredient: | almotriptan malate |
| Patents: | 0 |
Pharmacology for NDA: 205523
| Mechanism of Action | Serotonin 1b Receptor Agonists Serotonin 1d Receptor Agonists |
Suppliers and Packaging for NDA: 205523
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ALMOTRIPTAN MALATE | almotriptan malate | TABLET;ORAL | 205523 | ANDA | Ajanta Pharma USA Inc. | 27241-041 | 27241-041-11 | 1 BLISTER PACK in 1 CARTON (27241-041-11) / 6 TABLET, FILM COATED in 1 BLISTER PACK (27241-041-68) |
| ALMOTRIPTAN MALATE | almotriptan malate | TABLET;ORAL | 205523 | ANDA | Ajanta Pharma USA Inc. | 27241-042 | 27241-042-21 | 2 BLISTER PACK in 1 CARTON (27241-042-21) / 6 TABLET, FILM COATED in 1 BLISTER PACK (27241-042-68) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 6.25MG BASE | ||||
| Approval Date: | Mar 3, 2016 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 12.5MG BASE | ||||
| Approval Date: | Mar 3, 2016 | TE: | AB | RLD: | No | ||||
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