Application 219550
- Type
- ANDA
- Sponsor
- CHENGDU SHUODE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | METHYLENE BLUE | METHYLENE BLUE | SOLUTION;INTRAVENOUS | 50MG/10ML (5MG/ML) | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A219550-001 | METHYLENE BLUE | METHYLENE BLUE | 50MG/10ML (5MG/ML) | SOLUTION / INTRAVENOUS | AP | 2025-12-23 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A219550-001 | AP |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A219550-001 | METHYLENE BLUE | 50MG/10ML (5MG/ML) | SOLUTION / INTRAVENOUS | AP | 2025-12-23 | 011fe1cb6892… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A219550-001 | METHYLENE BLUE | 50MG/10ML (5MG/ML) | SOLUTION / INTRAVENOUS | AP | 2025-12-23 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A219550-001 | AP | 1 | 011fe1cb6892… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A219550-001 | AP | 1 | a50c72e98297… |
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 |
|---|---|---|---|---|---|---|
| METHYLENE BLUE | METHYLENE BLUE | GLENMARK PHARMACEUTICALS INC., USA | eec9bc86-b15b-4c0c-a669-65b03b73da0b | 2026-04-10 | Boxed warning, Warnings, Adverse reactions | 219550 ANDA219550 |
| METHYLENE BLUE | METHYLENE BLUE | Chengdu Shuode Pharmaceutical Co., Ltd | fe47491d-810e-466a-aab2-aa92756492ba | 2026-01-28 | Boxed warning, Warnings, Adverse reactions | 219550 ANDA219550 |