Details for New Drug Application (NDA): 207428
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NDA 207428 describes SOTALOL HYDROCHLORIDE, which is a drug marketed by Altathera Pharms Llc, Apotex, Aurobindo Pharma Usa, Beximco Pharms Usa, Epic Pharma Llc, Impax Pharms, Natco Pharma Usa, Oxford Pharms, 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 four 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-three 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-three suppliers are listed for this compound. Additional details are available on the sotalol hydrochloride profile page.
Summary for 207428
| Tradename: | SOTALOL HYDROCHLORIDE |
| Applicant: | Beximco Pharms Usa |
| Ingredient: | sotalol hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 207428
| Mechanism of Action | Adrenergic beta-Antagonists |
| Physiological Effect | Cardiac Rhythm Alteration |
Medical Subject Heading (MeSH) Categories for 207428
Suppliers and Packaging for NDA: 207428
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SOTALOL HYDROCHLORIDE | sotalol hydrochloride | TABLET;ORAL | 207428 | ANDA | Bryant Ranch Prepack | 71335-1189 | 71335-1189-1 | 60 TABLET in 1 BOTTLE (71335-1189-1) |
| SOTALOL HYDROCHLORIDE | sotalol hydrochloride | TABLET;ORAL | 207428 | ANDA | Bryant Ranch Prepack | 71335-1189 | 71335-1189-2 | 30 TABLET in 1 BOTTLE (71335-1189-2) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 80MG | ||||
| Approval Date: | Oct 21, 2016 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 120MG | ||||
| Approval Date: | Oct 21, 2016 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 160MG | ||||
| Approval Date: | Oct 21, 2016 | TE: | AB | RLD: | No | ||||
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