Details for New Drug Application (NDA): 075500
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NDA 075500 describes SORINE, which is a drug marketed by Aiping Pharm Inc and is included in one NDA. It is available from one supplier. Additional details are available on the SORINE profile page.
The generic ingredient in SORINE 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 SORINE 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 075500
| Tradename: | SORINE |
| Applicant: | Aiping Pharm Inc |
| Ingredient: | sotalol hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 075500
| Mechanism of Action | Adrenergic beta-Antagonists |
| Physiological Effect | Cardiac Rhythm Alteration |
Medical Subject Heading (MeSH) Categories for 075500
Suppliers and Packaging for NDA: 075500
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SORINE | sotalol hydrochloride | TABLET;ORAL | 075500 | ANDA | Upsher-Smith Laboratories, Inc. | 0245-0013 | 0245-0013-01 | 100 BLISTER PACK in 1 CARTON (0245-0013-01) / 1 TABLET in 1 BLISTER PACK (0245-0013-89) |
| SORINE | sotalol hydrochloride | TABLET;ORAL | 075500 | ANDA | Upsher-Smith Laboratories, Inc. | 0245-0014 | 0245-0014-01 | 100 BLISTER PACK in 1 CARTON (0245-0014-01) / 1 TABLET in 1 BLISTER PACK (0245-0014-89) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 80MG | ||||
| Approval Date: | Apr 27, 2001 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 160MG | ||||
| Approval Date: | Apr 27, 2001 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 240MG | ||||
| Approval Date: | Apr 27, 2001 | TE: | AB | RLD: | No | ||||
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