Details for New Drug Application (NDA): 207630
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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 207630
Tradename: | DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE |
Applicant: | Eugia Pharma |
Ingredient: | dorzolamide hydrochloride; timolol maleate |
Patents: | 0 |
Pharmacology for NDA: 207630
Mechanism of Action | Adrenergic beta-Antagonists Carbonic Anhydrase Inhibitors |
Suppliers and Packaging for NDA: 207630
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 | 207630 | ANDA | Aurobindo Pharma Limited | 65862-947 | 65862-947-18 | 12 POUCH in 1 CARTON (65862-947-18) / 15 VIAL, SINGLE-USE in 1 POUCH / .2 mL in 1 VIAL, SINGLE-USE |
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE | dorzolamide hydrochloride; timolol maleate | SOLUTION/DROPS;OPHTHALMIC | 207630 | ANDA | Aurobindo Pharma Limited | 65862-947 | 65862-947-60 | 4 POUCH in 1 CARTON (65862-947-60) / 15 VIAL, SINGLE-USE in 1 POUCH (65862-947-15) / .2 mL in 1 VIAL, SINGLE-USE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | EQ 2% BASE;EQ 0.5% BASE | ||||
Approval Date: | Jul 24, 2018 | TE: | AT2 | RLD: | No |
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