Details for New Drug Application (NDA): 207302
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NDA 207302 describes DARIFENACIN, which is a drug marketed by Macleods Pharms Ltd, Alembic, Aurobindo Pharma, Cipla, Endo Operations, Jubilant Generics, Polygen Pharms, Torrent, and Xiromed, and is included in nine NDAs. It is available from one supplier. Additional details are available on the DARIFENACIN profile page.
The generic ingredient in DARIFENACIN is darifenacin hydrobromide. There are nineteen drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the darifenacin hydrobromide profile page.
The generic ingredient in DARIFENACIN is darifenacin hydrobromide. There are nineteen drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the darifenacin hydrobromide profile page.
Summary for 207302
| Tradename: | DARIFENACIN |
| Applicant: | Macleods Pharms Ltd |
| Ingredient: | darifenacin hydrobromide |
| Patents: | 0 |
Pharmacology for NDA: 207302
| Mechanism of Action | Cholinergic Muscarinic Antagonists |
Suppliers and Packaging for NDA: 207302
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DARIFENACIN | darifenacin hydrobromide | TABLET, EXTENDED RELEASE;ORAL | 207302 | ANDA | Macleods Pharmaceuticals Limited | 33342-276 | 33342-276-07 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-276-07) |
| DARIFENACIN | darifenacin hydrobromide | TABLET, EXTENDED RELEASE;ORAL | 207302 | ANDA | Macleods Pharmaceuticals Limited | 33342-276 | 33342-276-10 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-276-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 7.5MG BASE | ||||
| Approval Date: | Jul 28, 2017 | 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: | Jul 28, 2017 | TE: | AB | RLD: | No | ||||
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