Details for New Drug Application (NDA): 205152
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NDA 205152 describes ELETRIPTAN HYDROBROMIDE, which is a drug marketed by Annora Pharma, Aurobindo Pharma, Chartwell Rx, Mylan, Regcon Holdings, Stevens J, Teva Pharms Usa, Yung Shin Pharm, and Zydus Pharms, and is included in nine NDAs. It is available from eleven suppliers. Additional details are available on the ELETRIPTAN HYDROBROMIDE profile page.
The generic ingredient in ELETRIPTAN HYDROBROMIDE is eletriptan hydrobromide. There are twelve drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the eletriptan hydrobromide profile page.
The generic ingredient in ELETRIPTAN HYDROBROMIDE is eletriptan hydrobromide. There are twelve drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the eletriptan hydrobromide profile page.
Summary for 205152
| Tradename: | ELETRIPTAN HYDROBROMIDE |
| Applicant: | Mylan |
| Ingredient: | eletriptan hydrobromide |
| Patents: | 0 |
Pharmacology for NDA: 205152
| Mechanism of Action | Serotonin 1b Receptor Agonists Serotonin 1d Receptor Agonists |
Suppliers and Packaging for NDA: 205152
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ELETRIPTAN HYDROBROMIDE | eletriptan hydrobromide | TABLET;ORAL | 205152 | ANDA | Mylan Pharmaceuticals Inc. | 0378-4287 | 0378-4287-85 | 1 BLISTER PACK in 1 CARTON (0378-4287-85) / 6 TABLET, FILM COATED in 1 BLISTER PACK (0378-4287-32) |
| ELETRIPTAN HYDROBROMIDE | eletriptan hydrobromide | TABLET;ORAL | 205152 | ANDA | Mylan Pharmaceuticals Inc. | 0378-4288 | 0378-4288-08 | 2 BLISTER PACK in 1 CARTON (0378-4288-08) / 6 TABLET, FILM COATED in 1 BLISTER PACK (0378-4288-32) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 20MG BASE | ||||
| Approval Date: | Aug 11, 2017 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 40MG BASE | ||||
| Approval Date: | Aug 11, 2017 | TE: | AB | RLD: | No | ||||
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