Application 217272
- Type
- ANDA
- Sponsor
- MANKIND PHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NITROFURANTOIN | NITROFURANTOIN, MACROCRYSTALLINE | CAPSULE;ORAL | 25MG | No | No |
| 002 | NITROFURANTOIN | NITROFURANTOIN, MACROCRYSTALLINE | CAPSULE;ORAL | 50MG | No | No |
| 003 | NITROFURANTOIN | NITROFURANTOIN, MACROCRYSTALLINE | CAPSULE;ORAL | 100MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A217272-001 | NITROFURANTOIN | NITROFURANTOIN, MACROCRYSTALLINE | 25MG | CAPSULE / ORAL | AB | 2023-03-21 | |
| A217272-002 | NITROFURANTOIN | NITROFURANTOIN, MACROCRYSTALLINE | 50MG | CAPSULE / ORAL | AB | 2023-03-21 | |
| A217272-003 | NITROFURANTOIN | NITROFURANTOIN, MACROCRYSTALLINE | 100MG | CAPSULE / ORAL | AB | 2023-03-21 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A217272-001 | AB |
| A217272-002 | AB |
| A217272-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A217272-001 | NITROFURANTOIN | 25MG | CAPSULE / ORAL | AB | 2023-03-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A217272-002 | NITROFURANTOIN | 50MG | CAPSULE / ORAL | AB | 2023-03-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A217272-003 | NITROFURANTOIN | 100MG | CAPSULE / ORAL | AB | 2023-03-21 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217272-001 | NITROFURANTOIN | 25MG | CAPSULE / ORAL | AB | 2023-03-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217272-002 | NITROFURANTOIN | 50MG | CAPSULE / ORAL | AB | 2023-03-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217272-003 | NITROFURANTOIN | 100MG | CAPSULE / ORAL | AB | 2023-03-21 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A217272-001 | NITROFURANTOIN | 25MG | CAPSULE / ORAL | AB | 2023-03-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A217272-002 | NITROFURANTOIN | 50MG | CAPSULE / ORAL | AB | 2023-03-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A217272-003 | NITROFURANTOIN | 100MG | CAPSULE / ORAL | AB | 2023-03-21 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A217272-001 | NITROFURANTOIN | 25MG | CAPSULE / ORAL | AB | 2023-03-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A217272-002 | NITROFURANTOIN | 50MG | CAPSULE / ORAL | AB | 2023-03-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A217272-003 | NITROFURANTOIN | 100MG | CAPSULE / ORAL | AB | 2023-03-21 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A217272-001 | NITROFURANTOIN | 25MG | CAPSULE / ORAL | AB | 2023-03-21 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A217272-002 | NITROFURANTOIN | 50MG | CAPSULE / ORAL | AB | 2023-03-21 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A217272-003 | NITROFURANTOIN | 100MG | CAPSULE / ORAL | AB | 2023-03-21 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A217272-001 | NITROFURANTOIN | 25MG | CAPSULE / ORAL | AB | 2023-03-21 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A217272-002 | NITROFURANTOIN | 50MG | CAPSULE / ORAL | AB | 2023-03-21 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A217272-003 | NITROFURANTOIN | 100MG | CAPSULE / ORAL | AB | 2023-03-21 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A217272-001 | NITROFURANTOIN | 25MG | CAPSULE / ORAL | AB | 2023-03-21 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A217272-002 | NITROFURANTOIN | 50MG | CAPSULE / ORAL | AB | 2023-03-21 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A217272-003 | NITROFURANTOIN | 100MG | CAPSULE / ORAL | AB | 2023-03-21 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A217272-001 | NITROFURANTOIN | 25MG | CAPSULE / ORAL | AB | 2023-03-21 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A217272-002 | NITROFURANTOIN | 50MG | CAPSULE / ORAL | AB | 2023-03-21 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A217272-003 | NITROFURANTOIN | 100MG | CAPSULE / ORAL | AB | 2023-03-21 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A217272-001 | NITROFURANTOIN | 25MG | CAPSULE / ORAL | AB | 2023-03-21 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A217272-002 | NITROFURANTOIN | 50MG | CAPSULE / ORAL | AB | 2023-03-21 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A217272-003 | NITROFURANTOIN | 100MG | CAPSULE / ORAL | AB | 2023-03-21 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A217272-001 | NITROFURANTOIN | 25MG | CAPSULE / ORAL | AB | 2023-03-21 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A217272-002 | NITROFURANTOIN | 50MG | CAPSULE / ORAL | AB | 2023-03-21 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A217272-003 | NITROFURANTOIN | 100MG | CAPSULE / ORAL | AB | 2023-03-21 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A217272-001 | NITROFURANTOIN | 25MG | CAPSULE / ORAL | AB | 2023-03-21 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A217272-002 | NITROFURANTOIN | 50MG | CAPSULE / ORAL | AB | 2023-03-21 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A217272-003 | NITROFURANTOIN | 100MG | CAPSULE / ORAL | AB | 2023-03-21 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A217272-001 | NITROFURANTOIN | 25MG | CAPSULE / ORAL | AB | 2023-03-21 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A217272-002 | NITROFURANTOIN | 50MG | CAPSULE / ORAL | AB | 2023-03-21 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A217272-003 | NITROFURANTOIN | 100MG | CAPSULE / ORAL | AB | 2023-03-21 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A217272-001 | NITROFURANTOIN | 25MG | CAPSULE / ORAL | AB | 2023-03-21 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A217272-002 | NITROFURANTOIN | 50MG | CAPSULE / ORAL | AB | 2023-03-21 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A217272-003 | NITROFURANTOIN | 100MG | CAPSULE / ORAL | AB | 2023-03-21 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A217272-001 | NITROFURANTOIN | 25MG | CAPSULE / ORAL | AB | 2023-03-21 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A217272-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A217272-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A217272-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217272-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217272-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217272-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A217272-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A217272-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A217272-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A217272-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A217272-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A217272-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A217272-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A217272-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A217272-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A217272-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A217272-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A217272-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A217272-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A217272-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A217272-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A217272-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A217272-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A217272-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A217272-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A217272-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A217272-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A217272-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A217272-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A217272-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A217272-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A217272-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A217272-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A217272-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A217272-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A217272-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A217272-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A217272-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A217272-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A217272-001 | AB | 1 | 8072bd15b7f6… |
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 |
|---|---|---|---|---|---|---|
| nitrofurantoin macrocrystals | NITROFURANTOIN MACROCRYSTALS | BluePoint Laboratories | cfa20cfd-478f-48c6-9b59-3c425abd766a | 2026-06-24 | Warnings, Adverse reactions | 217272 ANDA217272 |
| nitrofurantoin macrocrystals | NITROFURANTOIN MACROCRYSTALS | REMEDYREPACK INC. | 27f2ed1a-d4c2-4c12-92a6-3d0e9ce7f6a1 | 2026-06-09 | Warnings, Adverse reactions | 217272 ANDA217272 |
| nitrofurantoin macrocrystals | NITROFURANTOIN MACROCRYSTALS | Redpharm Drug | 52eea406-abb9-2713-e063-6294a90a00c6 | 2026-05-29 | Warnings, Adverse reactions | 217272 ANDA217272 |
| Nitrofurantoin Macrocrystals | NITROFURANTOIN MACROCRYSTALS | Direct_Rx | 10d05283-e247-4e60-e063-6294a90ac292 | 2026-03-05 | Warnings, Adverse reactions | 217272 ANDA217272 |
| nitrofurantoin macrocrystals | NITROFURANTOIN MACROCRYSTALS | Northwind Health Company, LLC | 075fe819-fc4f-2dce-e063-6294a90ad823 | 2025-12-26 | Warnings, Adverse reactions | 217272 ANDA217272 |
| nitrofurantoin macrocrystals | NITROFURANTOIN MACROCRYSTALS | VERITYRX, LLC | 42a1c744-93dc-31cc-e063-6294a90ab912 | 2025-11-02 | Warnings, Adverse reactions | 217272 ANDA217272 |
| nitrofurantoin macrocrystals | NITROFURANTOIN MACROCRYSTALS | PD-Rx Pharmaceuticals, Inc. | f28d72be-56d7-467f-a3f8-9ffd57d0dffa | 2025-06-10 | Warnings, Adverse reactions | 217272 ANDA217272 |
| nitrofurantoin macrocrystals | NITROFURANTOIN MACROCRYSTALS | Proficient Rx LP | ef7053f3-3081-49c4-9c78-d40a01177fd9 | 2024-08-19 | Warnings, Adverse reactions | 217272 ANDA217272 |
| nitrofurantoin | NITROFURANTOIN MACROCRYSTALS | A-S Medication Solutions | 4cd9e234-a2b9-4201-b8f8-cf37c0672de7 | 2024-08-15 | Warnings, Adverse reactions | 217272 ANDA217272 |
| Nitrofurantoin Macrocrystals | NITROFURANTOIN MACROCRYSTALS | American Health Packaging | ce4afef1-22c1-4a1c-a102-a32fb6a2e045 | 2024-04-28 | Warnings, Adverse reactions | 217272 ANDA217272 |
| nitrofurantoin macrocrystals | NITROFURANTOIN MACROCRYSTALS | NorthStar RxLLC | 1e3c284a-539d-4923-a5f6-547390baf811 | 2023-10-05 | Warnings, Adverse reactions | 217272 ANDA217272 |
| nitrofurantoin macrocrystals | NITROFURANTOIN MACROCRYSTALS | Bryant Ranch Prepack | af291b9c-d1b4-42c3-a1e9-bdf3b63fd7e6 | 2023-10-02 | Warnings, Adverse reactions | 217272 ANDA217272 |
| nitrofurantoin macrocrystals | NITROFURANTOIN MACROCRYSTALS | Bryant Ranch Prepack | 4bac93c7-dd35-4f5a-8067-5c6fcccc729d | 2023-08-15 | Warnings, Adverse reactions | 217272 ANDA217272 |
| nitrofurantoin macrocrystals | NITROFURANTOIN MACROCRYSTALS | Lifestar Pharma LLC | 6ec66cc8-938f-4839-98c7-a51c9f1d50ed | 2023-03-24 | Warnings, Adverse reactions | 217272 ANDA217272 |