Details for New Drug Application (NDA): 078771
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The generic ingredient in TIMOLOL MALEATE is timolol maleate. There are fifteen drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the timolol maleate profile page.
Summary for 078771
Tradename: | TIMOLOL MALEATE |
Applicant: | Mankind Pharma |
Ingredient: | timolol maleate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 078771
Mechanism of Action | Adrenergic beta-Antagonists |
Suppliers and Packaging for NDA: 078771
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TIMOLOL MALEATE | timolol maleate | SOLUTION/DROPS;OPHTHALMIC | 078771 | ANDA | Lifestar Pharma LLC | 70756-654 | 70756-654-15 | 1 BOTTLE, DROPPER in 1 CARTON (70756-654-15) / 5 mL in 1 BOTTLE, DROPPER |
TIMOLOL MALEATE | timolol maleate | SOLUTION/DROPS;OPHTHALMIC | 078771 | ANDA | Lifestar Pharma LLC | 70756-655 | 70756-655-30 | 1 BOTTLE, DROPPER in 1 CARTON (70756-655-30) / 10 mL in 1 BOTTLE, DROPPER |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | EQ 0.25% BASE | ||||
Approval Date: | Sep 28, 2009 | TE: | AT1 | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | EQ 0.5% BASE | ||||
Approval Date: | Sep 28, 2009 | TE: | AT1 | RLD: | No |
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