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Details for New Drug Application (NDA): 020865
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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DISINTEGRATING;ORAL | Strength | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | ||||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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