Details for New Drug Application (NDA): 019845
✉ Email this page to a colleague
The generic ingredient in BETOPTIC S 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 019845
Tradename: | BETOPTIC S |
Applicant: | Novartis |
Ingredient: | betaxolol hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 019845
Mechanism of Action | Adrenergic beta-Antagonists |
Medical Subject Heading (MeSH) Categories for 019845
Suppliers and Packaging for NDA: 019845
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
BETOPTIC S | betaxolol hydrochloride | SUSPENSION/DROPS;OPHTHALMIC | 019845 | NDA | Novartis Pharmaceuticals Corporation | 0078-0729 | 0078-0729-10 | 1 BOTTLE in 1 CARTON (0078-0729-10) / 10 mL in 1 BOTTLE |
BETOPTIC S | betaxolol hydrochloride | SUSPENSION/DROPS;OPHTHALMIC | 019845 | NDA | Novartis Pharmaceuticals Corporation | 0078-0729 | 0078-0729-15 | 1 BOTTLE in 1 CARTON (0078-0729-15) / 15 mL in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION/DROPS;OPHTHALMIC | Strength | EQ 0.25% BASE | ||||
Approval Date: | Dec 29, 1989 | TE: | RLD: | Yes |
Expired US Patents for NDA 019845
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Novartis | BETOPTIC S | betaxolol hydrochloride | SUSPENSION/DROPS;OPHTHALMIC | 019845-001 | Dec 29, 1989 | ⤷ Sign Up | ⤷ Sign Up |
Novartis | BETOPTIC S | betaxolol hydrochloride | SUSPENSION/DROPS;OPHTHALMIC | 019845-001 | Dec 29, 1989 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Complete Access Available with Subscription