Application 215041
- Type
- ANDA
- Sponsor
- NOVITIUM PHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | RIFABUTIN | RIFABUTIN | CAPSULE;ORAL | 150MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A215041-001 | RIFABUTIN | RIFABUTIN | 150MG | CAPSULE / ORAL | AB | 2021-12-17 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A215041-001 | AB |
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 | A215041-001 | RIFABUTIN | 150MG | CAPSULE / ORAL | AB | 2021-12-17 | 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 | A215041-001 | AB | 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 |
|---|---|---|---|---|---|---|
| Rifabutin | RIFABUTIN | REMEDYREPACK INC. | 754d2d7f-f0db-4f89-8fcd-5e2ff52d5030 | 2026-06-05 | Warnings, Adverse reactions | 215041 ANDA215041 |
| Rifabutin | RIFABUTIN | Marlex Pharmaceuticals, Inc. | df7d4103-42e4-4e4f-e053-2a95a90a8ce8 | 2025-11-18 | Warnings, Adverse reactions | 215041 ANDA215041 10135-738 |
| Rifabutin | RIFABUTIN | ANI Pharmaceuticals, Inc. | baf8ec98-bd0c-4b87-a7ee-813335431b89 | 2025-02-13 | Warnings, Adverse reactions | 215041 ANDA215041 70954-041 |