Details for New Drug Application (NDA): 217901
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NDA 217901 describes ATZUMI, which is a drug marketed by Satsuma Pharms and is included in one NDA. It is available from one supplier. There are six patents protecting this drug. Additional details are available on the ATZUMI profile page.
The generic ingredient in ATZUMI is dihydroergotamine mesylate. There are six drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the dihydroergotamine mesylate profile page.
The generic ingredient in ATZUMI is dihydroergotamine mesylate. There are six drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the dihydroergotamine mesylate profile page.
Summary for 217901
| Tradename: | ATZUMI |
| Applicant: | Satsuma Pharms |
| Ingredient: | dihydroergotamine mesylate |
| Patents: | 6 |
Suppliers and Packaging for NDA: 217901
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ATZUMI | dihydroergotamine mesylate | POWDER;NASAL | 217901 | NDA | Satsuma Pharmaceuticals, Inc. | 76978-101 | 76978-101-08 | 8 BOTTLE, UNIT-DOSE in 1 CARTON (76978-101-08) / 1 POWDER in 1 BOTTLE, UNIT-DOSE |
| ATZUMI | dihydroergotamine mesylate | POWDER;NASAL | 217901 | NDA | Satsuma Pharmaceuticals, Inc. | 76978-101 | 76978-101-11 | 1 BOTTLE, UNIT-DOSE in 1 CARTON (76978-101-11) / 1 POWDER in 1 BOTTLE, UNIT-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;NASAL | Strength | EQ 5.2MG BASE | ||||
| Approval Date: | Apr 30, 2025 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Apr 30, 2028 | ||||||||
| Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
| Patent: | ⤷ Get Started Free | Patent Expiration: | Dec 11, 2039 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Get Started Free | Patent Expiration: | Aug 4, 2037 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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