Details for New Drug Application (NDA): 205209
NDA 205209 describes DARIFENACIN HYDROBROMIDE, which is a drug marketed by Alembic, Alicora, Aurobindo Pharma, Cipla, Jubilant Generics, Ph Health, Torrent, and Xiromed, and is included in eight NDAs. It is available from seven suppliers. Additional details are available on the DARIFENACIN HYDROBROMIDE profile page.
The generic ingredient in DARIFENACIN HYDROBROMIDE is darifenacin hydrobromide. There is one drug master file entry for this compound. Eight suppliers are listed for this compound. Additional details are available on the darifenacin hydrobromide profile page.
The generic ingredient in DARIFENACIN HYDROBROMIDE is darifenacin hydrobromide. There is one drug master file entry for this compound. Eight suppliers are listed for this compound. Additional details are available on the darifenacin hydrobromide profile page.
Summary for 205209
| Tradename: | DARIFENACIN HYDROBROMIDE |
| Applicant: | Torrent |
| Ingredient: | darifenacin hydrobromide |
| Patents: | 0 |
Pharmacology for NDA: 205209
| Mechanism of Action | Cholinergic Muscarinic Antagonists |
Suppliers and Packaging for NDA: 205209
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DARIFENACIN HYDROBROMIDE | darifenacin hydrobromide | TABLET, EXTENDED RELEASE;ORAL | 205209 | ANDA | Torrent Pharmaceuticals Limited | 13668-202 | 13668-202-05 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-202-05) |
| DARIFENACIN HYDROBROMIDE | darifenacin hydrobromide | TABLET, EXTENDED RELEASE;ORAL | 205209 | ANDA | Torrent Pharmaceuticals Limited | 13668-202 | 13668-202-30 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-202-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 7.5MG BASE | ||||
| Approval Date: | Nov 17, 2016 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 15MG BASE | ||||
| Approval Date: | Nov 17, 2016 | TE: | AB | RLD: | No | ||||
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