Details for New Drug Application (NDA): 215623
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NDA 215623 describes DIHYDROERGOTAMINE MESYLATE, which is a drug marketed by Gland Pharma Ltd, Hikma, Hikma Pharms, Padagis Us, Provepharm Sas, Sagent Pharms Inc, Amneal, Cipla, and Rubicon, and is included in ten 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 215623
| Tradename: | DIHYDROERGOTAMINE MESYLATE |
| Applicant: | Gland Pharma Ltd |
| Ingredient: | dihydroergotamine mesylate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 215623
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DIHYDROERGOTAMINE MESYLATE | dihydroergotamine mesylate | INJECTABLE;INJECTION | 215623 | ANDA | Gland Pharma Limited | 68083-466 | 68083-466-10 | 10 AMPULE in 1 CARTON (68083-466-10) / 1 mL in 1 AMPULE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 1MG/ML | ||||
| Approval Date: | Aug 18, 2023 | TE: | AP | RLD: | No | ||||
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