Details for New Drug Application (NDA): 216747
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NDA 216747 describes DIHYDROERGOTAMINE MESYLATE, which is a drug marketed by Baxter Hlthcare Corp, Cipla, Gland Pharma Ltd, Hikma, Hikma Pharms, Padagis Us, Provepharm Sas, Sagent Pharms Inc, Aggrega, Amneal, and Rubicon, and is included in thirteen 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. Nine 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. Nine suppliers are listed for this compound. Additional details are available on the dihydroergotamine mesylate profile page.
Summary for 216747
| Tradename: | DIHYDROERGOTAMINE MESYLATE |
| Applicant: | Baxter Hlthcare Corp |
| Ingredient: | dihydroergotamine mesylate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 216747
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DIHYDROERGOTAMINE MESYLATE | dihydroergotamine mesylate | INJECTABLE;INJECTION | 216747 | ANDA | Baxter Healthcare Corporation | 36000-300 | 36000-300-10 | 10 AMPULE in 1 CARTON (36000-300-10) / 1 mL in 1 AMPULE (36000-300-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 1MG/ML | ||||
| Approval Date: | Jan 7, 2025 | TE: | AP | RLD: | No | ||||
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