Application 050429
- Type
- NDA
- Sponsor
- OXFORD PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | RIMACTANE | RIFAMPIN | CAPSULE;ORAL | 300MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N050429-001 | RIMACTANE | RIFAMPIN | 300MG | CAPSULE / ORAL | AB | Approved before 1982 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N050429-001 | 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 | N050429-001 | RIMACTANE | 300MG | CAPSULE / ORAL | AB | Approved before 1982 | 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 | N050429-001 | 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 |
|---|---|---|---|---|---|---|
| Rifadin IV | RIFAMPIN | Sanofi-Aventis U.S. LLC | 036ab68e-5085-4edc-bd83-784b43d64eab | 2026-05-27 | Warnings, Adverse reactions | RIFAMPIN |
| Rifampin | RIFAMPIN | Mylan Institutional LLC | 8be91604-d7cd-4f2b-997d-e3364e4092e5 | 2026-05-05 | Warnings, Adverse reactions | RIFAMPIN |
| rifampin | RIFAMPIN | Bryant Ranch Prepack | 0cb75e95-d165-4580-9340-42d7a9fd546e | 2026-03-12 | Warnings, Adverse reactions | RIFAMPIN |
| rifampin | RIFAMPIN | Major Pharmaceuticals | 3f3534c1-95e4-4bdd-b044-9026e4addf0c | 2026-02-27 | Warnings, Adverse reactions | RIFAMPIN |
| rifampin | RIFAMPIN | Lupin Pharmaceuticals, Inc. | b56004f0-f23d-47f6-80c7-39884fccbccc | 2026-02-11 | Warnings, Adverse reactions | RIFAMPIN |
| rifampin | RIFAMPIN | A-S Medication Solutions | d53b6998-6e3b-4c6f-8465-2af6897d1efe | 2026-01-05 | Warnings, Adverse reactions | RIFAMPIN |
| RIFAMPIN | RIFAMPIN | Coupler LLC | 410a314f-83bf-d9b3-e063-6294a90a872c | 2025-10-13 | Warnings, Adverse reactions | RIFAMPIN |
| Rifampin | RIFAMPIN | American Health Packaging | 50f706f9-5003-4e15-bece-85b6213b1f5c | 2025-08-20 | Warnings, Adverse reactions | RIFAMPIN |
| RIFAMPIN | RIFAMPIN | PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS | 28109dee-3e5e-492b-b7d9-9ba46c0b5324 | 2025-03-25 | Warnings, Adverse reactions | RIFAMPIN |
| Rifampin | RIFAMPIN | ANI Pharmaceuticals, Inc. | b389b1a3-672f-47e3-916c-4a9c044b211b | 2024-10-10 | Warnings, Adverse reactions | RIFAMPIN |
| RIFAMPIN | RIFAMPIN | EPIC PHARMA, LLC | 0391f1e1-70d4-4b15-8b58-055bb6a385b8 | 2023-12-20 | Warnings, Adverse reactions | RIFAMPIN |
| Rifampin | RIFAMPIN | Chartwell RX, LLC | 4c39ee75-ae96-456d-bf47-16d49865345e | 2023-04-12 | Warnings, Adverse reactions | RIFAMPIN |
| Rifampin | RIFAMPIN | Fresenius Kabi USA, LLC | a1f9f1e2-dfc0-4d31-a13b-b656d897b791 | 2022-08-29 | Warnings, Adverse reactions | RIFAMPIN |
| Rifampin | RIFAMPIN | Hikma Pharmaceuticals USA Inc. | cb59a48c-f66b-4ea0-809c-de0e4be2f8c2 | 2022-01-28 | Warnings, Adverse reactions | RIFAMPIN |