Details for New Drug Application (NDA): 213730
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NDA 213730 describes CLORAZEPATE DIPOTASSIUM, which is a drug marketed by Able, Am Therap, Dash Pharms, Dava Pharms Inc, Gd Searle Llc, Purepac Pharm, Quantum Pharmics, Rising, Usl Pharma, Warner Chilcott, Watson Labs, Aurobindo Pharma, Aurolife Pharma Llc, Corepharma, Lederle, Novitium Pharma, Sun Pharm Inds Ltd, and Taro, and is included in fifty-eight NDAs. It is available from nine suppliers. Additional details are available on the CLORAZEPATE DIPOTASSIUM profile page.
The generic ingredient in CLORAZEPATE DIPOTASSIUM is clorazepate dipotassium. There are eight drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the clorazepate dipotassium profile page.
The generic ingredient in CLORAZEPATE DIPOTASSIUM is clorazepate dipotassium. There are eight drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the clorazepate dipotassium profile page.
Summary for 213730
| Tradename: | CLORAZEPATE DIPOTASSIUM |
| Applicant: | Novitium Pharma |
| Ingredient: | clorazepate dipotassium |
| Patents: | 0 |
Suppliers and Packaging for NDA: 213730
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CLORAZEPATE DIPOTASSIUM | clorazepate dipotassium | TABLET;ORAL | 213730 | ANDA | Coupler LLC | 67046-1462 | 67046-1462-3 | 30 TABLET in 1 BLISTER PACK (67046-1462-3) |
| CLORAZEPATE DIPOTASSIUM | clorazepate dipotassium | TABLET;ORAL | 213730 | ANDA | ANI Pharmaceuticals, Inc. | 70954-157 | 70954-157-10 | 100 TABLET in 1 BOTTLE (70954-157-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 3.75MG | ||||
| Approval Date: | Jun 16, 2022 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 7.5MG | ||||
| Approval Date: | Jun 16, 2022 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 15MG | ||||
| Approval Date: | Dec 16, 2022 | TE: | AB | RLD: | No | ||||
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