Details for New Drug Application (NDA): 021214
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The generic ingredient in RESCULA is unoprostone isopropyl. There are four drug master file entries for this compound. Additional details are available on the unoprostone isopropyl profile page.
Summary for 021214
Tradename: | RESCULA |
Applicant: | Sucampo Pharma Llc |
Ingredient: | unoprostone isopropyl |
Patents: | 0 |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | 0.15% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Aug 3, 2000 | TE: | RLD: | Yes |
Expired US Patents for NDA 021214
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Sucampo Pharma Llc | RESCULA | unoprostone isopropyl | SOLUTION/DROPS;OPHTHALMIC | 021214-001 | Aug 3, 2000 | ⤷ Sign Up | ⤷ Sign Up |
Sucampo Pharma Llc | RESCULA | unoprostone isopropyl | SOLUTION/DROPS;OPHTHALMIC | 021214-001 | Aug 3, 2000 | ⤷ Sign Up | ⤷ Sign Up |
Sucampo Pharma Llc | RESCULA | unoprostone isopropyl | SOLUTION/DROPS;OPHTHALMIC | 021214-001 | Aug 3, 2000 | ⤷ Sign Up | ⤷ Sign Up |
Sucampo Pharma Llc | RESCULA | unoprostone isopropyl | SOLUTION/DROPS;OPHTHALMIC | 021214-001 | Aug 3, 2000 | ⤷ Sign Up | ⤷ Sign Up |
Sucampo Pharma Llc | RESCULA | unoprostone isopropyl | SOLUTION/DROPS;OPHTHALMIC | 021214-001 | Aug 3, 2000 | ⤷ Sign Up | ⤷ Sign Up |
Sucampo Pharma Llc | RESCULA | unoprostone isopropyl | SOLUTION/DROPS;OPHTHALMIC | 021214-001 | Aug 3, 2000 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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