Details for New Drug Application (NDA): 075429
✉ Email this page to a colleague
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 075429
Tradename: | SOTALOL HYDROCHLORIDE |
Applicant: | Teva |
Ingredient: | sotalol hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 075429
Mechanism of Action | Adrenergic beta-Antagonists |
Physiological Effect | Cardiac Rhythm Alteration |
Medical Subject Heading (MeSH) Categories for 075429
Suppliers and Packaging for NDA: 075429
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
SOTALOL HYDROCHLORIDE | sotalol hydrochloride | TABLET;ORAL | 075429 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-1060 | 0093-1060-01 | 100 TABLET in 1 BOTTLE (0093-1060-01) |
SOTALOL HYDROCHLORIDE | sotalol hydrochloride | TABLET;ORAL | 075429 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-1061 | 0093-1061-01 | 100 TABLET in 1 BOTTLE (0093-1061-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 80MG | ||||
Approval Date: | May 1, 2000 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 120MG | ||||
Approval Date: | May 1, 2000 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 160MG | ||||
Approval Date: | May 1, 2000 | TE: | AB | RLD: | No |
Complete Access Available with Subscription