Details for New Drug Application (NDA): 078962
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NDA 078962 describes BETAXOLOL HYDROCHLORIDE, which is a drug marketed by Acella, Apotex Inc, Medimetriks Pharms, Sciegen Pharms Inc, Epic Pharma, and Kvk Tech, and is included in six NDAs. It is available from three suppliers. Additional details are available on the BETAXOLOL HYDROCHLORIDE profile page.
The generic ingredient in BETAXOLOL HYDROCHLORIDE is betaxolol hydrochloride. There are eleven drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the betaxolol hydrochloride profile page.
The generic ingredient in BETAXOLOL HYDROCHLORIDE is betaxolol hydrochloride. There are eleven drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the betaxolol hydrochloride profile page.
Summary for 078962
| Tradename: | BETAXOLOL HYDROCHLORIDE |
| Applicant: | Kvk Tech |
| Ingredient: | betaxolol hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 078962
| Mechanism of Action | Adrenergic beta-Antagonists |
Medical Subject Heading (MeSH) Categories for 078962
Suppliers and Packaging for NDA: 078962
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BETAXOLOL HYDROCHLORIDE | betaxolol hydrochloride | TABLET;ORAL | 078962 | ANDA | KVK-TECH, INC. | 10702-013 | 10702-013-01 | 100 TABLET, COATED in 1 BOTTLE (10702-013-01) |
| BETAXOLOL HYDROCHLORIDE | betaxolol hydrochloride | TABLET;ORAL | 078962 | ANDA | KVK-TECH, INC. | 10702-014 | 10702-014-01 | 100 TABLET, COATED in 1 BOTTLE (10702-014-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | Jun 27, 2008 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 20MG | ||||
| Approval Date: | Jun 27, 2008 | TE: | AB | RLD: | No | ||||
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