Details for New Drug Application (NDA): 205770
✉ Email this page to a colleague
NDA 205770 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 205770
| Tradename: | BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE |
| Applicant: | Endo Operations |
| Ingredient: | bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride |
| Patents: | 0 |
Suppliers and Packaging for NDA: 205770
| 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 | 205770 | ANDA | Par Pharmaceutical, Inc. | 49884-151 | 49884-151-54 | 120 CAPSULE in 1 CARTON (49884-151-54) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 140MG;125MG;125MG | ||||
| Approval Date: | Mar 6, 2023 | TE: | AB | RLD: | No | ||||
Complete Access Available with Subscription
