Details for New Drug Application (NDA): 217511
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NDA 217511 describes BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE, which is a drug marketed by Endo Operations and Novast Labs and is included in two NDAs. It is available from two suppliers. Additional details are available on the BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE profile page.
The generic ingredient in BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE is bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride. There are twenty-two drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride profile page.
The generic ingredient in BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE is bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride. There are twenty-two drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride profile page.
Summary for 217511
| Tradename: | BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE |
| Applicant: | Novast Labs |
| Ingredient: | bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride |
| Patents: | 0 |
Suppliers and Packaging for NDA: 217511
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE | bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride | CAPSULE;ORAL | 217511 | ANDA | Ingenus Pharmaceuticals, LLC | 50742-283 | 50742-283-13 | 120 CAPSULE in 1 CARTON (50742-283-13) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 140MG;125MG;125MG | ||||
| Approval Date: | Jul 3, 2023 | TE: | AB | RLD: | No | ||||
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