Application 214082
- Type
- ANDA
- Sponsor
- ETON
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CYSTEINE HYDROCHLORIDE | CYSTEINE HYDROCHLORIDE | SOLUTION;INTRAVENOUS | 500MG/10ML (50MG/ML) | No | No |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A214082-001 | CYSTEINE HYDROCHLORIDE | 500MG/10ML (50MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-04-08 | 5c6f7cd8ea54… | |
| 2023-01-26 05:58 UTC | 2023-01 | A214082-001 | CYSTEINE HYDROCHLORIDE | 500MG/10ML (50MG/ML) | SOLUTION / INTRAVENOUS | 2022-04-08 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A214082-001 | CYSTEINE HYDROCHLORIDE | 500MG/10ML (50MG/ML) | SOLUTION / INTRAVENOUS | 2022-04-08 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A214082-001 | CYSTEINE HYDROCHLORIDE | 500MG/10ML (50MG/ML) | SOLUTION / INTRAVENOUS | 2022-04-08 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A214082-001 | CYSTEINE HYDROCHLORIDE | 500MG/10ML (50MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-04-08 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A214082-001 | CYSTEINE HYDROCHLORIDE | 500MG/10ML (50MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-04-08 | cb3db0bc1861… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A214082-001 | AP | 1 | 5c6f7cd8ea54… |
| 2022-09-29 23:25 UTC | 2022-09 | A214082-001 | AP | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A214082-001 | AP | 1 | cb3db0bc1861… |
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 |
|---|---|---|---|---|---|---|
| ELCYS | CYSTEINE HYDROCHLORIDE | Exela Pharma Sciences, LLC | 52317b38-b2e6-4a1c-b5b0-43cada0d205e | 2026-04-09 | Warnings, Adverse reactions | CYSTEINE HYDROCHLORIDE |
| ELCYS | CYSTEINE HYDROCHLORIDE | Exela Pharma Sciences, LLC | e7652275-1c53-490c-82ad-e63867df5788 | 2024-02-01 | Warnings, Adverse reactions | CYSTEINE HYDROCHLORIDE |
| ELCYS | CYSTEINE HYDROCHLORIDE | Exela Pharma Sciences, LLC | 9a52ae2f-1cea-4ad5-a074-66bbf06578d3 | 2024-02-01 | Warnings, Adverse reactions | CYSTEINE HYDROCHLORIDE |
| CYSTEINE HYDROCHLORIDE | CYSTEINE HYDROCHLORIDE | Baxter Healthcare Corporation | cbf70fc3-14b3-4c17-8de8-acba1e12ac95 | 2022-04-29 | Warnings, Adverse reactions | CYSTEINE HYDROCHLORIDE CYSTEINE HYDROCHLORIDE |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 71918 | ORIG | 2022-08-26 |