Application 200740
- Type
- NDA
- Sponsor
- LEADIANT BIOSCI INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CYSTARAN | CYSTEAMINE HYDROCHLORIDE | SOLUTION/DROPS;OPHTHALMIC | EQ 0.44% BASE | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N200740-001 | CYSTARAN | CYSTEAMINE HYDROCHLORIDE | EQ 0.44% BASE | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 2012-10-02 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2022-09-29 23:25 UTC | 2022-09 | N200740-001 | CYSTARAN | EQ 0.44% BASE | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 2012-10-02 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N200740-001 | CYSTARAN | EQ 0.44% BASE | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 2012-10-02 | cb3db0bc1861… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N200740-001 | CYSTARAN | EQ 0.44% BASE | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 2012-10-02 | a50c72e98297… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | N200740-001 | ODE-31 | 2019-10-02 | 74a2ff9319b5… |
| 2019-12-14 00:12 UTC | 2019-12 | N200740-001 | ODE-31 | 2019-10-02 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N200740-001 | ODE-31 | 2019-10-02 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N200740-001 | ODE-31 | 2019-10-02 | ea99ee380514… |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| CYSTARAN | CYSTEAMINE HYDROCHLORIDE | Leadiant Biosciences, Inc. | b98ee838-ed23-42a9-93b5-72579e490fba | 2025-04-30 | Warnings, Adverse reactions | 200740 NDA200740 54482-020 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| 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 |