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. Twenty-nine 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 |
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 | 019463-001 | Nov 5, 1986 | ⤷ Sign Up | ⤷ Sign Up |
Bausch And Lomb Inc | TIMOPTIC IN OCUDOSE | timolol maleate | SOLUTION/DROPS;OPHTHALMIC | 019463-002 | Nov 5, 1986 | ⤷ Sign Up | ⤷ Sign Up |
Bausch And Lomb Inc | TIMOPTIC IN OCUDOSE | timolol maleate | SOLUTION/DROPS;OPHTHALMIC | 019463-002 | Nov 5, 1986 | ⤷ Sign Up | ⤷ Sign Up |
Bausch And Lomb Inc | TIMOPTIC IN OCUDOSE | timolol maleate | SOLUTION/DROPS;OPHTHALMIC | 019463-001 | Nov 5, 1986 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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