Application 217357
- Type
- ANDA
- Sponsor
- MANKIND PHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE | CAPSULE;ORAL | 75MG;25MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A217357-001 | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE | 75MG;25MG | CAPSULE / ORAL | AB | 2023-07-11 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A217357-001 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A217357-001 | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | 75MG;25MG | CAPSULE / ORAL | AB | 2023-07-11 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217357-001 | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | 75MG;25MG | CAPSULE / ORAL | AB | 2023-07-11 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A217357-001 | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | 75MG;25MG | CAPSULE / ORAL | AB | 2023-07-11 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A217357-001 | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | 75MG;25MG | CAPSULE / ORAL | AB | 2023-07-11 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A217357-001 | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | 75MG;25MG | CAPSULE / ORAL | AB | 2023-07-11 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A217357-001 | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | 75MG;25MG | CAPSULE / ORAL | AB | 2023-07-11 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A217357-001 | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | 75MG;25MG | CAPSULE / ORAL | AB | 2023-07-11 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A217357-001 | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | 75MG;25MG | CAPSULE / ORAL | AB | 2023-07-11 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A217357-001 | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | 75MG;25MG | CAPSULE / ORAL | AB | 2023-07-11 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A217357-001 | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | 75MG;25MG | CAPSULE / ORAL | AB | 2023-07-11 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A217357-001 | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | 75MG;25MG | CAPSULE / ORAL | AB | 2023-07-11 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A217357-001 | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | 75MG;25MG | CAPSULE / ORAL | AB | 2023-07-11 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A217357-001 | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | 75MG;25MG | CAPSULE / ORAL | AB | 2023-07-11 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A217357-001 | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | 75MG;25MG | CAPSULE / ORAL | AB | 2023-07-11 | 8072bd15b7f6… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A217357-001 | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | 75MG;25MG | CAPSULE / ORAL | AB | 2023-07-11 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A217357-001 | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | 75MG;25MG | CAPSULE / ORAL | AB | 2023-07-11 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A217357-001 | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | 75MG;25MG | CAPSULE / ORAL | AB | 2023-07-11 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A217357-001 | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | 75MG;25MG | CAPSULE / ORAL | AB | 2023-07-11 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A217357-001 | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | 75MG;25MG | CAPSULE / ORAL | AB | 2023-07-11 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A217357-001 | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | 75MG;25MG | CAPSULE / ORAL | AB | 2023-07-11 | a67488948f0b… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A217357-001 | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | 75MG;25MG | CAPSULE / ORAL | AB | 2023-07-11 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A217357-001 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217357-001 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A217357-001 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A217357-001 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A217357-001 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A217357-001 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A217357-001 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A217357-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A217357-001 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A217357-001 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A217357-001 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A217357-001 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A217357-001 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A217357-001 | AB | 1 | 8072bd15b7f6… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A217357-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A217357-001 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A217357-001 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A217357-001 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A217357-001 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A217357-001 | AB | 1 | a67488948f0b… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A217357-001 | AB | 1 | 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 |
|---|---|---|---|---|---|---|
| Nitrofurantoin (monohydrate/macrocrystals) | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | BluePoint Laboratories | ea28d766-d6e6-43d2-8282-dc78a0381057 | 2026-06-24 | Warnings, Adverse reactions | 217357 ANDA217357 |
| Nitrofurantoin (monohydrate/macrocrystals) | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | Coupler LLC | 513b514f-6e79-f187-e063-6394a90a07dc | 2026-05-07 | Warnings, Adverse reactions | 217357 ANDA217357 |
| Nitrofurantoin (monohydrate/macrocrystals) | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | Coupler LLC | 5087f071-5ef4-753e-e063-6294a90afb8d | 2026-04-28 | Warnings, Adverse reactions | 217357 ANDA217357 |
| Nitrofurantoin (monohydrate/macrocrystals) | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | REMEDYREPACK INC. | e55f3dc2-c754-4550-a2c0-c304471a8791 | 2026-04-27 | Warnings, Adverse reactions | 217357 ANDA217357 |
| Nitrofurantoin (monohydrate/macrocrystals) | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | Major Pharmaceuticals | 85c7d4ee-99f5-4324-a5fa-601c2fe664ab | 2026-04-06 | Warnings, Adverse reactions | 217357 ANDA217357 |
| Nitrofurantoin (monohydrate/macrocrystals) | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | Redpharm Drug | 18987b15-6554-6b55-e063-6294a90a58d4 | 2026-03-11 | Warnings, Adverse reactions | 217357 ANDA217357 |
| Nitrofurantoin (monohydrate/macrocrystals) | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | Preferred Pharmaceuticals Inc. | 11e8f91c-5712-4267-9956-e619d081d1f4 | 2026-01-16 | Warnings, Adverse reactions | 217357 ANDA217357 |
| Nitrofurantoin (monohydrate/macrocrystals) | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | NuCare Pharmaceuticals,Inc. | 155c8d68-576e-f85c-e063-6294a90ada4b | 2025-12-10 | Warnings, Adverse reactions | 217357 ANDA217357 |
| Nitrofurantoin (monohydrate/macrocrystals) | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | REMEDYREPACK INC. | 4553ccc1-0bad-4c75-aae2-1a1c87bc8db0 | 2025-06-17 | Warnings, Adverse reactions | 217357 ANDA217357 |
| Nitrofurantoin (monohydrate/macrocrystals) | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | Bryant Ranch Prepack | 63a4b367-bf4b-4b5f-b3e9-394ba307886d | 2025-04-10 | Warnings, Adverse reactions | 217357 ANDA217357 |
| Nitrofurantoin (monohydrate/macrocrystals) | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | Proficient Rx LP | f49f586a-79f0-4731-97f9-9aeb0839ece5 | 2024-08-19 | Warnings, Adverse reactions | 217357 ANDA217357 |
| Nitrofurantoin | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | NuCare Pharmaceuticals,Inc. | 10e2503d-a250-996f-e063-6294a90abd61 | 2024-02-28 | Warnings, Adverse reactions | 217357 ANDA217357 |
| Nitrofurantoin (monohydrate/macrocrystals) | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | NorthStar RxLLC | d1c778b5-70df-4312-976b-d0bca0cb602a | 2023-10-05 | Warnings, Adverse reactions | 217357 ANDA217357 |
| Nitrofurantoin (monohydrate/macrocrystals) | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | Lifestar Pharma LLC | 35c0a6d8-ff85-4d9b-9ad3-ae20808119dd | 2023-07-14 | Warnings, Adverse reactions | 217357 ANDA217357 |