Details for New Drug Application (NDA): 213436
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NDA 213436 describes TRUDHESA, which is a drug marketed by Impel 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 TRUDHESA profile page.
The generic ingredient in TRUDHESA is dihydroergotamine mesylate. There are six drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the dihydroergotamine mesylate profile page.
The generic ingredient in TRUDHESA is dihydroergotamine mesylate. There are six drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the dihydroergotamine mesylate profile page.
Summary for 213436
| Tradename: | TRUDHESA |
| Applicant: | Impel Pharms |
| Ingredient: | dihydroergotamine mesylate |
| Patents: | 6 |
Suppliers and Packaging for NDA: 213436
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TRUDHESA | dihydroergotamine mesylate | SPRAY, METERED;NASAL | 213436 | NDA | Impel Pharmaceuticals Inc. | 77530-725 | 77530-725-00 | 1 VIAL, GLASS in 1 CARTON (77530-725-00) / 1 mL in 1 VIAL, GLASS |
| TRUDHESA | dihydroergotamine mesylate | SPRAY, METERED;NASAL | 213436 | NDA | Impel Pharmaceuticals Inc. | 77530-725 | 77530-725-04 | 4 VIAL, GLASS in 1 CARTON (77530-725-04) / 1 mL in 1 VIAL, GLASS |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SPRAY, METERED;NASAL | Strength | 0.725MG/SPRAY | ||||
| Approval Date: | Sep 2, 2021 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Sep 2, 2024 | ||||||||
| Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Dec 25, 2032 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Sign Up | Patent Expiration: | Jan 23, 2033 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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