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Details for New Drug Application (NDA): 020865
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NDA 020865 describes MAXALT-MLT, which is a drug marketed by Merck and is included in one NDA. It is available from one supplier. Additional details are available on the MAXALT-MLT profile page.
The generic ingredient in MAXALT-MLT is rizatriptan benzoate. There are twenty-two drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the rizatriptan benzoate profile page.
The generic ingredient in MAXALT-MLT is rizatriptan benzoate. There are twenty-two drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the rizatriptan benzoate profile page.
Summary for 020865
| Tradename: | MAXALT-MLT |
| Applicant: | Merck |
| Ingredient: | rizatriptan benzoate |
| Patents: | 0 |
Pharmacology for NDA: 020865
| Mechanism of Action | Serotonin 1b Receptor Agonists Serotonin 1d Receptor Agonists |
Suppliers and Packaging for NDA: 020865
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MAXALT-MLT | rizatriptan benzoate | TABLET, ORALLY DISINTEGRATING;ORAL | 020865 | NDA | Merck Sharp & Dohme Corp. | 0006-3801 | 0006-3801-18 | 6 CONTAINER in 1 CARTON (0006-3801-18) > 3 POUCH in 1 CONTAINER > 1 BLISTER PACK in 1 POUCH (0006-3801-01) > 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK |
Paragraph IV (Patent) Challenges for 020865
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| MAXALT-MLT | TABLET, ORALLY DISINTEGRATING;ORAL | rizatriptan benzoate | 020865 | 2006-02-17 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | ||||
| Approval Date: | Jun 29, 1998 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | EQ 10MG BASE | ||||
| Approval Date: | Jun 29, 1998 | TE: | AB | RLD: | Yes | ||||
Expired US Patents for NDA 020865
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Merck | MAXALT-MLT | rizatriptan benzoate | TABLET, ORALLY DISINTEGRATING;ORAL | 020865-001 | Jun 29, 1998 | Start Trial | Start Trial |
| Merck | MAXALT-MLT | rizatriptan benzoate | TABLET, ORALLY DISINTEGRATING;ORAL | 020865-002 | Jun 29, 1998 | Start Trial | Start Trial |
| Merck | MAXALT-MLT | rizatriptan benzoate | TABLET, ORALLY DISINTEGRATING;ORAL | 020865-002 | Jun 29, 1998 | Start Trial | Start Trial |
| Merck | MAXALT-MLT | rizatriptan benzoate | TABLET, ORALLY DISINTEGRATING;ORAL | 020865-002 | Jun 29, 1998 | Start Trial | Start Trial |
| Merck | MAXALT-MLT | rizatriptan benzoate | TABLET, ORALLY DISINTEGRATING;ORAL | 020865-002 | Jun 29, 1998 | Start Trial | Start Trial |
| Merck | MAXALT-MLT | rizatriptan benzoate | TABLET, ORALLY DISINTEGRATING;ORAL | 020865-001 | Jun 29, 1998 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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