Details for New Drug Application (NDA): 200740
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The generic ingredient in CYSTARAN 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 200740
Tradename: | CYSTARAN |
Applicant: | Leadiant Biosci Inc |
Ingredient: | cysteamine hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 200740
Mechanism of Action | Cystine Disulfide Reduction |
Suppliers and Packaging for NDA: 200740
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CYSTARAN | cysteamine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 200740 | NDA | Leadiant Biosciences, Inc. | 54482-020 | 54482-020-02 | 15 mL in 1 BOTTLE (54482-020-02) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | EQ 0.44% BASE | ||||
Approval Date: | Oct 2, 2012 | TE: | RLD: | Yes |
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