Details for New Drug Application (NDA): 076214
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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 076214
Tradename: | SOTALOL HYDROCHLORIDE |
Applicant: | Apotex |
Ingredient: | sotalol hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 076214
Mechanism of Action | Adrenergic beta-Antagonists |
Physiological Effect | Cardiac Rhythm Alteration |
Medical Subject Heading (MeSH) Categories for 076214
Suppliers and Packaging for NDA: 076214
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
SOTALOL HYDROCHLORIDE | sotalol hydrochloride | TABLET;ORAL | 076214 | ANDA | Apotex Corp. | 60505-0222 | 60505-0222-1 | 100 TABLET in 1 BOTTLE, PLASTIC (60505-0222-1) |
SOTALOL HYDROCHLORIDE | sotalol hydrochloride | TABLET;ORAL | 076214 | ANDA | Apotex Corp. | 60505-0222 | 60505-0222-2 | 1000 TABLET in 1 BOTTLE, PLASTIC (60505-0222-2) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 80MG | ||||
Approval Date: | Aug 27, 2003 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 120MG | ||||
Approval Date: | Aug 27, 2003 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 160MG | ||||
Approval Date: | Aug 27, 2003 | TE: | AB | RLD: | No |
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