Details for New Drug Application (NDA): 216881
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NDA 216881 describes DIHYDROERGOTAMINE MESYLATE, which is a drug marketed by Cipla, Gland Pharma Ltd, Hikma, Hikma Pharms, Padagis Us, Provepharm Sas, Sagent Pharms Inc, Amneal, and Rubicon, and is included in eleven NDAs. It is available from seven suppliers. Additional details are available on the DIHYDROERGOTAMINE MESYLATE profile page.
The generic ingredient in DIHYDROERGOTAMINE MESYLATE 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 DIHYDROERGOTAMINE MESYLATE 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 216881
| Tradename: | DIHYDROERGOTAMINE MESYLATE |
| Applicant: | Rubicon |
| Ingredient: | dihydroergotamine mesylate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 216881
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DIHYDROERGOTAMINE MESYLATE | dihydroergotamine mesylate | SPRAY, METERED;NASAL | 216881 | ANDA | Advagen Pharma Ltd | 72888-096 | 72888-096-19 | 8 KIT in 1 KIT (72888-096-19) / 1 VIAL, GLASS in 1 KIT (72888-096-18) / 1 mL in 1 VIAL, GLASS |
| DIHYDROERGOTAMINE MESYLATE | dihydroergotamine mesylate | SPRAY, METERED;NASAL | 216881 | ANDA | Advagen Pharma Ltd | 72888-096 | 72888-096-34 | 1 VIAL, GLASS in 1 KIT (72888-096-34) / 1 mL in 1 VIAL, GLASS |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SPRAY, METERED;NASAL | Strength | 0.5MG/SPRAY | ||||
| Approval Date: | Jun 22, 2023 | TE: | AB | RLD: | No | ||||
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