Details for New Drug Application (NDA): 211302
NDA 211302 describes CYSTADROPS, which is a drug marketed by Recordati Rare and is included in one NDA. It is available from one supplier. Additional details are available on the CYSTADROPS profile page.
The generic ingredient in CYSTADROPS is cysteamine hydrochloride. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the cysteamine hydrochloride profile page.
The generic ingredient in CYSTADROPS is cysteamine hydrochloride. There is one drug master file entry 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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