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Details for New Drug Application (NDA): 019219
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NDA 019219 describes BETAGAN, which is a drug marketed by Allergan and is included in two NDAs. It is available from one supplier. Additional details are available on the BETAGAN profile page.
The generic ingredient in BETAGAN is levobunolol hydrochloride. There are seven drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the levobunolol hydrochloride profile page.
The generic ingredient in BETAGAN is levobunolol hydrochloride. There are seven drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the levobunolol hydrochloride profile page.
Summary for 019219
| Tradename: | BETAGAN |
| Applicant: | Allergan |
| Ingredient: | levobunolol hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 019219
| Mechanism of Action | Adrenergic beta-Antagonists |
Medical Subject Heading (MeSH) Categories for 019219
Suppliers and Packaging for NDA: 019219
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BETAGAN | levobunolol hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 019219 | NDA AUTHORIZED GENERIC | Pacific Pharma, Inc. | 60758-060 | 60758-060-05 | 1 BOTTLE, DROPPER in 1 CARTON (60758-060-05) > 5 mL in 1 BOTTLE, DROPPER |
| BETAGAN | levobunolol hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 019219 | NDA AUTHORIZED GENERIC | Pacific Pharma, Inc. | 60758-060 | 60758-060-10 | 1 BOTTLE, DROPPER in 1 CARTON (60758-060-10) > 10 mL in 1 BOTTLE, DROPPER |
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | 0.5% | ||||
| Approval Date: | Dec 19, 1985 | TE: | AT | RLD: | Yes | ||||
Expired US Patents for NDA 019219
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Allergan | BETAGAN | levobunolol hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 019219-002 | Dec 19, 1985 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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