Details for New Drug Application (NDA): 200740
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NDA 200740 describes CYSTARAN, which is a drug marketed by Leadiant Biosci Inc and is included in one NDA. It is available from one supplier. Additional details are available on the CYSTARAN profile page.
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.
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 |
| Formulation / Manufacturing: | see details |
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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