Application 205024
- Type
- ANDA
- Sponsor
- QUAGEN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | RITONAVIR | RITONAVIR | CAPSULE;ORAL | 100MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A205024-001 | RITONAVIR | RITONAVIR | 100MG | CAPSULE / ORAL | 2024-02-16 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A205024-001 | RITONAVIR | 100MG | CAPSULE / ORAL | 2024-02-16 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A205024-001 | RITONAVIR | 100MG | CAPSULE / ORAL | 2024-02-16 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205024-001 | RITONAVIR | 100MG | CAPSULE / ORAL | 2024-02-16 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A205024-001 | RITONAVIR | 100MG | CAPSULE / ORAL | 2024-02-16 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205024-001 | RITONAVIR | 100MG | CAPSULE / ORAL | 2024-02-16 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205024-001 | RITONAVIR | 100MG | CAPSULE / ORAL | 2024-02-16 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205024-001 | RITONAVIR | 100MG | CAPSULE / ORAL | 2024-02-16 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205024-001 | RITONAVIR | 100MG | CAPSULE / ORAL | 2024-02-16 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205024-001 | RITONAVIR | 100MG | CAPSULE / ORAL | 2024-02-16 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A205024-001 | RITONAVIR | 100MG | CAPSULE / ORAL | 2024-02-16 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A205024-001 | RITONAVIR | 100MG | CAPSULE / ORAL | 2024-02-16 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A205024-001 | RITONAVIR | 100MG | CAPSULE / ORAL | 2024-02-16 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A205024-001 | RITONAVIR | 100MG | CAPSULE / ORAL | 2024-02-16 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A205024-001 | RITONAVIR | 100MG | CAPSULE / ORAL | 2024-02-16 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A205024-001 | RITONAVIR | 100MG | CAPSULE / ORAL | 2024-02-16 | 8072bd15b7f6… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A205024-001 | RITONAVIR | 100MG | CAPSULE / ORAL | 2024-02-16 | 6a51e52b5d6a… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A205024-001 | RITONAVIR | 100MG | CAPSULE / ORAL | 2024-02-16 | 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 |
|---|---|---|---|---|---|---|
| Norvir | RITONAVIR | AbbVie Inc. | 2849298e-de6e-47bb-8194-56e075b33fc3 | 2026-07-23 | Boxed warning, Warnings, Adverse reactions | RITONAVIR |
| Ritonavir | RITONAVIR | Bryant Ranch Prepack | d2f8c6ba-5e06-4b03-8ca5-b4fd7e5a8925 | 2026-03-11 | Boxed warning, Warnings, Adverse reactions | Ritonavir RITONAVIR |
| Ritonavir | RITONAVIR | NuCare Pharmaceuticals, Inc. | 3f92f1e2-59f4-f6c4-e063-6294a90a487b | 2025-09-24 | Boxed warning, Warnings, Adverse reactions | Ritonavir RITONAVIR |
| Ritonavir | RITONAVIR | Bryant Ranch Prepack | 3c811e3e-f685-4af7-a4d1-037f2613ee68 | 2025-06-05 | Boxed warning, Warnings, Adverse reactions | Ritonavir RITONAVIR |
| Ritonavir | RITONAVIR | American Health Packaging | 19503bc4-3443-4ad4-aa27-437f4f3288b1 | 2024-04-13 | Boxed warning, Warnings, Adverse reactions | Ritonavir RITONAVIR |
| Ritonavir | RITONAVIR | Aurobindo Pharma Limited | 11f757f1-cf48-47a8-925e-918359cbd2d4 | 2023-11-13 | Boxed warning, Warnings, Adverse reactions | Ritonavir RITONAVIR |
| Ritonavir | RITONAVIR | Camber Pharmaceuticals, Inc. | db633374-6d8e-4622-9fe1-f9d68baa59bb | 2023-02-22 | Boxed warning, Warnings, Adverse reactions | Ritonavir RITONAVIR |
| Ritonavir | RITONAVIR | Amneal Pharmaceuticals LLC | a32cb2e3-d4e5-4bbf-9d88-20b2b249e779 | 2020-11-30 | Boxed warning, Warnings, Adverse reactions | Ritonavir RITONAVIR |