Details for New Drug Application (NDA): 020258
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The generic ingredient in IOPIDINE is apraclonidine hydrochloride. There are three drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the apraclonidine hydrochloride profile page.
Summary for 020258
Tradename: | IOPIDINE |
Applicant: | Harrow Eye |
Ingredient: | apraclonidine hydrochloride |
Patents: | 0 |
Suppliers and Packaging for NDA: 020258
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
IOPIDINE | apraclonidine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 020258 | NDA AUTHORIZED GENERIC | Sandoz Inc | 61314-665 | 61314-665-05 | 5 mL in 1 BOTTLE (61314-665-05) |
IOPIDINE | apraclonidine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 020258 | NDA AUTHORIZED GENERIC | Sandoz Inc | 61314-665 | 61314-665-10 | 10 mL in 1 BOTTLE (61314-665-10) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | EQ 0.5% BASE | ||||
Approval Date: | Jul 30, 1993 | TE: | AT | RLD: | Yes |
Expired US Patents for NDA 020258
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Harrow Eye | IOPIDINE | apraclonidine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 020258-001 | Jul 30, 1993 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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