Application 200740
- Type
- NDA
- Sponsor
- LEADIANT BIOSCI INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | CYSTARAN | CYSTEAMINE HYDROCHLORIDE | SOLUTION/DROPS;OPHTHALMIC | EQ 0.44% BASE | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 54482-020 | CYSTARAN | cysteamine hydrochloride | Leadiant Biosciences, Inc. | NDA | Current |
| 54482-020 | CYSTARAN | cysteamine hydrochloride | Leadiant Biosciences, Inc. | NDA | Current |
| 54482-020 | CYSTARAN | cysteamine hydrochloride | Leadiant Biosciences, Inc. | NDA | Current |
| 54482-020 | CYSTARAN | cysteamine hydrochloride | Leadiant Biosciences, Inc. | NDA | Current |
| 54482-020 | CYSTARAN | cysteamine hydrochloride | Leadiant Biosciences, Inc. | NDA | Current |
| 54482-020 | CYSTARAN | cysteamine hydrochloride | Leadiant Biosciences, Inc. | NDA | Current |
| 54482-020 | CYSTARAN | cysteamine hydrochloride | Leadiant Biosciences, Inc. | NDA | Current |
| 54482-020 | CYSTARAN | cysteamine hydrochloride | Leadiant Biosciences, Inc. | NDA | Current |
| 54482-020 | CYSTARAN | cysteamine hydrochloride | Leadiant Biosciences, Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 70347 | SUPPL | 2022-03-02 |
| 70290 | SUPPL | 2022-02-28 |
| 62698 | SUPPL | 2020-04-28 |
| 62690 | SUPPL | 2020-04-27 |
| 44827 | ORIG | 2013-08-26 |
| 43355 | ORIG | 2013-08-26 |
| 18979 | ORIG | 2012-10-04 |
| 9848 | ORIG | 2012-10-04 |