Details for New Drug Application (NDA): 205186
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NDA 205186 describes ELETRIPTAN HYDROBROMIDE, which is a drug marketed by Ajanta Pharma Ltd, Aurobindo Pharma, Beximco Pharms Usa, Mylan, Stevens J, Teva Pharms Usa, Yung Shin Pharm, and Zydus Pharms, and is included in eight NDAs. It is available from ten 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. Twelve 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. Twelve suppliers are listed for this compound. Additional details are available on the eletriptan hydrobromide profile page.
Summary for 205186
| Tradename: | ELETRIPTAN HYDROBROMIDE |
| Applicant: | Ajanta Pharma Ltd |
| Ingredient: | eletriptan hydrobromide |
| Patents: | 0 |
Pharmacology for NDA: 205186
| Mechanism of Action | Serotonin 1b Receptor Agonists Serotonin 1d Receptor Agonists |
Suppliers and Packaging for NDA: 205186
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ELETRIPTAN HYDROBROMIDE | eletriptan hydrobromide | TABLET;ORAL | 205186 | ANDA | Ajanta Pharma USA Inc. | 27241-039 | 27241-039-11 | 1 BLISTER PACK in 1 CARTON (27241-039-11) / 6 TABLET, FILM COATED in 1 BLISTER PACK (27241-039-68) |
| ELETRIPTAN HYDROBROMIDE | eletriptan hydrobromide | TABLET;ORAL | 205186 | ANDA | Ajanta Pharma USA Inc. | 27241-040 | 27241-040-11 | 1 BLISTER PACK in 1 CARTON (27241-040-11) / 6 TABLET, FILM COATED in 1 BLISTER PACK (27241-040-68) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 20MG BASE | ||||
| Approval Date: | Aug 29, 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 29, 2017 | TE: | AB | RLD: | No | ||||
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