Details for New Drug Application (NDA): 020869
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The generic ingredient in COSOPT 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 020869
Tradename: | COSOPT |
Applicant: | Thea Pharma |
Ingredient: | dorzolamide hydrochloride; timolol maleate |
Patents: | 0 |
Pharmacology for NDA: 020869
Mechanism of Action | Adrenergic beta-Antagonists Carbonic Anhydrase Inhibitors |
Suppliers and Packaging for NDA: 020869
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
COSOPT | dorzolamide hydrochloride; timolol maleate | SOLUTION/DROPS;OPHTHALMIC | 020869 | NDA | Thea Pharma Inc. | 82584-605 | 82584-605-10 | 1 BOTTLE, DROPPER in 1 CARTON (82584-605-10) / 10 mL in 1 BOTTLE, DROPPER |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | EQ 2% BASE;EQ 0.5% BASE | ||||
Approval Date: | Apr 7, 1998 | TE: | AT1 | RLD: | Yes |
Expired US Patents for NDA 020869
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Thea Pharma | COSOPT | dorzolamide hydrochloride; timolol maleate | SOLUTION/DROPS;OPHTHALMIC | 020869-001 | Apr 7, 1998 | ⤷ Sign Up | ⤷ Sign Up |
Thea Pharma | COSOPT | dorzolamide hydrochloride; timolol maleate | SOLUTION/DROPS;OPHTHALMIC | 020869-001 | Apr 7, 1998 | ⤷ Sign Up | ⤷ Sign Up |
Thea Pharma | COSOPT | dorzolamide hydrochloride; timolol maleate | SOLUTION/DROPS;OPHTHALMIC | 020869-001 | Apr 7, 1998 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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