Application 216955
- Type
- ANDA
- Sponsor
- STERISCIENCE
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 |
|---|---|---|---|---|---|---|---|
| A216955-001 | METHYLENE BLUE | METHYLENE BLUE | 50MG/10ML (5MG/ML) | SOLUTION / INTRAVENOUS | AP | 2024-11-22 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A216955-001 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A216955-001 | METHYLENE BLUE | 50MG/10ML (5MG/ML) | SOLUTION / INTRAVENOUS | AP | 2024-11-22 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A216955-001 | AP | 1 | a50c72e98297… |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Methylene blue | METHYLENE BLUE | Steriscience Specialties Private Limited | eb87d31c-3a8e-4089-9693-20bc17279650 | 2026-01-14 | Boxed warning, Warnings, Adverse reactions | 216955 ANDA216955 |
| Methylene blue | METHYLENE BLUE | Amneal Pharmaceuticals LLC | 67da2a69-8166-46c7-921c-d6ec47bfeac8 | 2025-11-19 | Boxed warning, Warnings, Adverse reactions | 216955 ANDA216955 |