Details for New Drug Application (NDA): 019463
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The generic ingredient in TIMOPTIC IN OCUDOSE is timolol maleate. There are fifteen drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the timolol maleate profile page.
Summary for 019463
Tradename: | TIMOPTIC IN OCUDOSE |
Applicant: | Bausch And Lomb Inc |
Ingredient: | timolol maleate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 019463
Mechanism of Action | Adrenergic beta-Antagonists |
Suppliers and Packaging for NDA: 019463
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TIMOPTIC IN OCUDOSE | timolol maleate | SOLUTION/DROPS;OPHTHALMIC | 019463 | NDA | Bausch Health US LLC | 0187-1496 | 0187-1496-05 | 4 POUCH in 1 CARTON (0187-1496-05) > 15 CONTAINER in 1 POUCH > .3 mL in 1 CONTAINER |
TIMOPTIC IN OCUDOSE | timolol maleate | SOLUTION/DROPS;OPHTHALMIC | 019463 | NDA | Bausch Health US LLC | 0187-1496 | 0187-1496-99 | 10 POUCH in 1 CARTON (0187-1496-99) > .3 mL in 1 POUCH |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | EQ 0.25% BASE | ||||
Approval Date: | Nov 5, 1986 | TE: | AT3 | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | EQ 0.5% BASE | ||||
Approval Date: | Nov 5, 1986 | TE: | AT3 | RLD: | Yes |
Expired US Patents for NDA 019463
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Bausch And Lomb Inc | TIMOPTIC IN OCUDOSE | timolol maleate | SOLUTION/DROPS;OPHTHALMIC | 019463-002 | Nov 5, 1986 | See Plans and Pricing | See Plans and Pricing |
Bausch And Lomb Inc | TIMOPTIC IN OCUDOSE | timolol maleate | SOLUTION/DROPS;OPHTHALMIC | 019463-001 | Nov 5, 1986 | See Plans and Pricing | See Plans and Pricing |
Bausch And Lomb Inc | TIMOPTIC IN OCUDOSE | timolol maleate | SOLUTION/DROPS;OPHTHALMIC | 019463-002 | Nov 5, 1986 | See Plans and Pricing | See Plans and Pricing |
Bausch And Lomb Inc | TIMOPTIC IN OCUDOSE | timolol maleate | SOLUTION/DROPS;OPHTHALMIC | 019463-001 | Nov 5, 1986 | See Plans and Pricing | See Plans and Pricing |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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