Details for New Drug Application (NDA): 211302
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The generic ingredient in CYSTADROPS is cysteamine hydrochloride. There are six drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the cysteamine hydrochloride profile page.
Summary for 211302
Tradename: | CYSTADROPS |
Applicant: | Recordati Rare |
Ingredient: | cysteamine hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 211302
Mechanism of Action | Cystine Disulfide Reduction |
Suppliers and Packaging for NDA: 211302
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CYSTADROPS | cysteamine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 211302 | NDA | RECORDATI RARE DISEASES, INC. | 55292-410 | 55292-410-05 | 1 BOTTLE, GLASS in 1 BOX (55292-410-05) / 5 mL in 1 BOTTLE, GLASS |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | EQ 0.37% BASE | ||||
Approval Date: | Aug 19, 2020 | TE: | RLD: | Yes |
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