Details for New Drug Application (NDA): 203808
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NDA 203808 describes TINIDAZOLE, which is a drug marketed by Chartwell Rx, Edenbridge Pharms, Hikma, and Thinq Pharm-cro Pvt, and is included in four NDAs. It is available from six suppliers. Additional details are available on the TINIDAZOLE profile page.
The generic ingredient in TINIDAZOLE is tinidazole. There are six drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the tinidazole profile page.
The generic ingredient in TINIDAZOLE is tinidazole. There are six drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the tinidazole profile page.
Summary for 203808
| Tradename: | TINIDAZOLE |
| Applicant: | Edenbridge Pharms |
| Ingredient: | tinidazole |
| Patents: | 0 |
Suppliers and Packaging for NDA: 203808
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TINIDAZOLE | tinidazole | TABLET;ORAL | 203808 | ANDA | Edenbridge Pharmaceuticals LLC. | 42799-207 | 42799-207-01 | 40 TABLET in 1 BOTTLE (42799-207-01) |
| TINIDAZOLE | tinidazole | TABLET;ORAL | 203808 | ANDA | Edenbridge Pharmaceuticals LLC. | 42799-208 | 42799-208-01 | 20 TABLET in 1 BOTTLE (42799-208-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 250MG | ||||
| Approval Date: | Aug 4, 2015 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 500MG | ||||
| Approval Date: | Aug 4, 2015 | TE: | AB | RLD: | No | ||||
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