Details for New Drug Application (NDA): 020330
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The generic ingredient in TIMOPTIC-XE is timolol maleate. There are fifteen drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the timolol maleate profile page.
Summary for 020330
Tradename: | TIMOPTIC-XE |
Applicant: | Bausch And Lomb Inc |
Ingredient: | timolol maleate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 020330
Mechanism of Action | Adrenergic beta-Antagonists |
Suppliers and Packaging for NDA: 020330
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TIMOPTIC-XE | timolol maleate | SOLUTION, GEL FORMING/DROPS;OPHTHALMIC | 020330 | NDA | Bausch & Lomb Incorporated | 24208-814 | 24208-814-25 | 1 BOTTLE, DISPENSING in 1 CARTON (24208-814-25) / 5 mL in 1 BOTTLE, DISPENSING |
TIMOPTIC-XE | timolol maleate | SOLUTION, GEL FORMING/DROPS;OPHTHALMIC | 020330 | NDA | Bausch & Lomb Incorporated | 24208-816 | 24208-816-05 | 1 BOTTLE, DISPENSING in 1 CARTON (24208-816-05) / 5 mL in 1 BOTTLE, DISPENSING |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION, GEL FORMING/DROPS;OPHTHALMIC | Strength | EQ 0.25% BASE | ||||
Approval Date: | Nov 4, 1993 | TE: | AB | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION, GEL FORMING/DROPS;OPHTHALMIC | Strength | EQ 0.5% BASE | ||||
Approval Date: | Nov 4, 1993 | TE: | AB | RLD: | Yes |
Expired US Patents for NDA 020330
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Bausch And Lomb Inc | TIMOPTIC-XE | timolol maleate | SOLUTION, GEL FORMING/DROPS;OPHTHALMIC | 020330-001 | Nov 4, 1993 | ⤷ Sign Up | ⤷ Sign Up |
Bausch And Lomb Inc | TIMOPTIC-XE | timolol maleate | SOLUTION, GEL FORMING/DROPS;OPHTHALMIC | 020330-002 | Nov 4, 1993 | ⤷ Sign Up | ⤷ Sign Up |
Bausch And Lomb Inc | TIMOPTIC-XE | timolol maleate | SOLUTION, GEL FORMING/DROPS;OPHTHALMIC | 020330-001 | Nov 4, 1993 | ⤷ Sign Up | ⤷ Sign Up |
Bausch And Lomb Inc | TIMOPTIC-XE | timolol maleate | SOLUTION, GEL FORMING/DROPS;OPHTHALMIC | 020330-002 | Nov 4, 1993 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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