Details for New Drug Application (NDA): 215520
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The generic ingredient in DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE is dorzolamide hydrochloride; timolol maleate. There are fifteen drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the dorzolamide hydrochloride; timolol maleate profile page.
Summary for 215520
Tradename: | DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE |
Applicant: | Gland Pharma Ltd |
Ingredient: | dorzolamide hydrochloride; timolol maleate |
Patents: | 0 |
Pharmacology for NDA: 215520
Mechanism of Action | Adrenergic beta-Antagonists Carbonic Anhydrase Inhibitors |
Suppliers and Packaging for NDA: 215520
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE | dorzolamide hydrochloride; timolol maleate | SOLUTION/DROPS;OPHTHALMIC | 215520 | ANDA | Gland Pharma Limited | 68083-490 | 68083-490-01 | 1 BOTTLE in 1 CARTON (68083-490-01) / 10 mL in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | EQ 2% BASE;EQ 0.5% BASE | ||||
Approval Date: | Sep 19, 2022 | TE: | AT1 | RLD: | No |
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