Details for New Drug Application (NDA): 207429
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NDA 207429 describes SOTALOL HYDROCHLORIDE, which is a drug marketed by Altathera Pharms Llc, Apotex, Aurobindo Pharma Usa, Epic Pharma Llc, Impax Pharms, Novitium Pharma, Oxford Pharms, Regcon Holdings, Rising, Sun Pharm Industries, Teva, Upsher Smith Labs, and Watson Labs, and is included in seventeen NDAs. It is available from eighteen suppliers. There are six patents protecting this drug. Additional details are available on the SOTALOL HYDROCHLORIDE profile page.
The generic ingredient in SOTALOL HYDROCHLORIDE is sotalol hydrochloride. There are ten drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the sotalol hydrochloride profile page.
The generic ingredient in SOTALOL HYDROCHLORIDE is sotalol hydrochloride. There are ten drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the sotalol hydrochloride profile page.
Summary for 207429
| Tradename: | SOTALOL HYDROCHLORIDE |
| Applicant: | Regcon Holdings |
| Ingredient: | sotalol hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 207429
| Mechanism of Action | Adrenergic beta-Antagonists |
| Physiological Effect | Cardiac Rhythm Alteration |
Medical Subject Heading (MeSH) Categories for 207429
Suppliers and Packaging for NDA: 207429
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SOTALOL HYDROCHLORIDE | sotalol hydrochloride | TABLET;ORAL | 207429 | ANDA | Bayshore Pharmaceuticals LLC | 76385-125 | 76385-125-01 | 100 TABLET in 1 BOTTLE, PLASTIC (76385-125-01) |
| SOTALOL HYDROCHLORIDE | sotalol hydrochloride | TABLET;ORAL | 207429 | ANDA | Bayshore Pharmaceuticals LLC | 76385-125 | 76385-125-50 | 500 TABLET in 1 BOTTLE, PLASTIC (76385-125-50) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 80MG | ||||
| Approval Date: | Nov 2, 2018 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 120MG | ||||
| Approval Date: | Nov 2, 2018 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 160MG | ||||
| Approval Date: | Nov 2, 2018 | TE: | AB | RLD: | No | ||||
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