Application 201722
- Type
- ANDA
- Sponsor
- SUN PHARM INDUSTRIES
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 |
|---|---|---|---|---|---|---|---|
| A201722-001 | NITROFURANTOIN | NITROFURANTOIN, MACROCRYSTALLINE | 25MG | CAPSULE / ORAL | 2016-02-16 | ||
| A201722-002 | NITROFURANTOIN | NITROFURANTOIN, MACROCRYSTALLINE | 50MG | CAPSULE / ORAL | 2016-02-16 | ||
| A201722-003 | NITROFURANTOIN | NITROFURANTOIN, MACROCRYSTALLINE | 100MG | CAPSULE / ORAL | 2016-02-16 |
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 | A201722-001 | NITROFURANTOIN | 25MG | CAPSULE / ORAL | 2016-02-16 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A201722-002 | NITROFURANTOIN | 50MG | CAPSULE / ORAL | 2016-02-16 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A201722-003 | NITROFURANTOIN | 100MG | CAPSULE / ORAL | 2016-02-16 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A201722-001 | NITROFURANTOIN | 25MG | CAPSULE / ORAL | 2016-02-16 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A201722-002 | NITROFURANTOIN | 50MG | CAPSULE / ORAL | 2016-02-16 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A201722-003 | NITROFURANTOIN | 100MG | CAPSULE / ORAL | 2016-02-16 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201722-001 | NITROFURANTOIN | 25MG | CAPSULE / ORAL | AB | 2016-02-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201722-002 | NITROFURANTOIN | 50MG | CAPSULE / ORAL | AB | 2016-02-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201722-003 | NITROFURANTOIN | 100MG | CAPSULE / ORAL | AB | 2016-02-16 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A201722-001 | NITROFURANTOIN | 25MG | CAPSULE / ORAL | AB | 2016-02-16 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A201722-002 | NITROFURANTOIN | 50MG | CAPSULE / ORAL | AB | 2016-02-16 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A201722-003 | NITROFURANTOIN | 100MG | CAPSULE / ORAL | AB | 2016-02-16 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201722-001 | NITROFURANTOIN | 25MG | CAPSULE / ORAL | AB | 2016-02-16 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201722-002 | NITROFURANTOIN | 50MG | CAPSULE / ORAL | AB | 2016-02-16 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201722-003 | NITROFURANTOIN | 100MG | CAPSULE / ORAL | AB | 2016-02-16 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201722-001 | NITROFURANTOIN | 25MG | CAPSULE / ORAL | AB | 2016-02-16 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201722-002 | NITROFURANTOIN | 50MG | CAPSULE / ORAL | AB | 2016-02-16 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201722-003 | NITROFURANTOIN | 100MG | CAPSULE / ORAL | AB | 2016-02-16 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201722-001 | NITROFURANTOIN | 25MG | CAPSULE / ORAL | AB | 2016-02-16 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201722-002 | NITROFURANTOIN | 50MG | CAPSULE / ORAL | AB | 2016-02-16 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201722-003 | NITROFURANTOIN | 100MG | CAPSULE / ORAL | AB | 2016-02-16 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A201722-001 | NITROFURANTOIN | 25MG | CAPSULE / ORAL | AB | 2016-02-16 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A201722-002 | NITROFURANTOIN | 50MG | CAPSULE / ORAL | AB | 2016-02-16 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A201722-003 | NITROFURANTOIN | 100MG | CAPSULE / ORAL | AB | 2016-02-16 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A201722-001 | NITROFURANTOIN | 25MG | CAPSULE / ORAL | AB | 2016-02-16 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A201722-002 | NITROFURANTOIN | 50MG | CAPSULE / ORAL | AB | 2016-02-16 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A201722-003 | NITROFURANTOIN | 100MG | CAPSULE / ORAL | AB | 2016-02-16 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A201722-001 | NITROFURANTOIN | 25MG | CAPSULE / ORAL | AB | 2016-02-16 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A201722-002 | NITROFURANTOIN | 50MG | CAPSULE / ORAL | AB | 2016-02-16 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A201722-003 | NITROFURANTOIN | 100MG | CAPSULE / ORAL | AB | 2016-02-16 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A201722-001 | NITROFURANTOIN | 25MG | CAPSULE / ORAL | AB | 2016-02-16 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A201722-002 | NITROFURANTOIN | 50MG | CAPSULE / ORAL | AB | 2016-02-16 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A201722-003 | NITROFURANTOIN | 100MG | CAPSULE / ORAL | AB | 2016-02-16 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A201722-001 | NITROFURANTOIN | 25MG | CAPSULE / ORAL | AB | 2016-02-16 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A201722-002 | NITROFURANTOIN | 50MG | CAPSULE / ORAL | AB | 2016-02-16 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A201722-003 | NITROFURANTOIN | 100MG | CAPSULE / ORAL | AB | 2016-02-16 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A201722-001 | NITROFURANTOIN | 25MG | CAPSULE / ORAL | AB | 2016-02-16 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A201722-002 | NITROFURANTOIN | 50MG | CAPSULE / ORAL | AB | 2016-02-16 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A201722-003 | NITROFURANTOIN | 100MG | CAPSULE / ORAL | AB | 2016-02-16 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A201722-001 | NITROFURANTOIN | 25MG | CAPSULE / ORAL | AB | 2016-02-16 | 1e350fbaab3a… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201722-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201722-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201722-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A201722-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A201722-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A201722-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201722-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201722-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201722-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201722-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201722-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201722-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201722-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201722-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201722-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A201722-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A201722-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A201722-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A201722-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A201722-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A201722-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A201722-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A201722-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A201722-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A201722-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A201722-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A201722-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A201722-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A201722-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A201722-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A201722-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A201722-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A201722-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A201722-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A201722-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A201722-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A201722-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A201722-002 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A201722-003 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A201722-001 | AB | 1 | 5c6f7cd8ea54… |
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 |
|---|---|---|---|---|---|---|
| Nitrofurantion | NITROFURANTION | Bryant Ranch Prepack | eeb12928-61ab-42a0-a1fa-2819b9ffa3cb | 2026-06-24 | Warnings, Adverse reactions | 201722 ANDA201722 71335-0024 |
| Nitrofurantion | NITROFURANTION | Sun Pharmaceutical Industries, Inc. | 05f25774-f56a-48ef-bac3-8af663f8581a | 2026-04-06 | Warnings, Adverse reactions | 201722 ANDA201722 57664-233 57664-231 57664-232 |
| Nitrofurantion | NITROFURANTION | NuCare Pharmaceuticals,Inc. | bd46cc46-0efa-d5d9-e053-2995a90a18f1 | 2026-02-19 | Warnings, Adverse reactions | 201722 ANDA201722 68071-2363 |
| Nitrofurantion | NITROFURANTION | A-S Medication Solutions | 43848e61-4d94-46f7-a610-93be927c8d16 | 2023-12-09 | Warnings, Adverse reactions | 201722 ANDA201722 50090-5693 |
| Nitrofurantion | NITROFURANTION | Proficient Rx LP | 870f64ca-0256-4e3f-8c34-dc603ccc41c0 | 2022-05-02 | Warnings, Adverse reactions | 201722 ANDA201722 71205-171 |
| Nitrofurantion | NITROFURANTION | BluePoint Labortories | ad020393-1c97-49da-b0f3-d6a9359fb73d | 2019-05-14 | Warnings, Adverse reactions | 201722 ANDA201722 68001-384 68001-386 68001-385 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 50090-5693 | Nitrofurantion | Nitrofurantion | A-S Medication Solutions | ANDA | Current |
| 50090-5693 | Nitrofurantion | Nitrofurantion | A-S Medication Solutions | ANDA | Current |
| 55700-893 | Nitrofurantion | Nitrofurantion | Quality Care Products, LLC | ANDA | Current |
| 55700-893 | Nitrofurantion | Nitrofurantion | Quality Care Products, LLC | ANDA | Current |
| 57664-231 | Nitrofurantion | Nitrofurantion | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 57664-232 | Nitrofurantion | Nitrofurantion | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 57664-233 | Nitrofurantion | Nitrofurantion | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 60687-472 | Nitrofurantoin | Nitrofurantoin | American Health Packaging | ANDA | Current |
| 60687-472 | Nitrofurantoin | Nitrofurantoin | American Health Packaging | ANDA | Current |
| 60687-483 | Nitrofurantoin | Nitrofurantoin | American Health Packaging | ANDA | Current |
| 60687-483 | Nitrofurantoin | Nitrofurantoin | American Health Packaging | ANDA | Current |
| 61919-024 | NITROFURANTION | NITROFURANTION | DIRECT RX | ANDA | Current |
| 61919-024 | NITROFURANTION | NITROFURANTION | DIRECT RX | ANDA | Current |
| 68001-384 | Nitrofurantion | Nitrofurantion | BluePoint Labortories | ANDA | Current |
| 68001-385 | Nitrofurantion | Nitrofurantion | BluePoint Labortories | ANDA | Current |
| 68001-386 | Nitrofurantion | Nitrofurantion | BluePoint Labortories | ANDA | Current |
| 68071-2363 | Nitrofurantion | Nitrofurantion | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-2647 | Nitrofurantion | Nitrofurantion | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-3134 | Nitrofurantion | Nitrofurantion | NuCare Pharmaceuticals Industries, Inc. | ANDA | Current |
| 70518-3041 | Nitrofurantion | Nitrofurantion | REMEDYREPACK INC. | ANDA | Current |
| 70934-413 | Nitrofurantion | Nitrofurantion | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-413 | Nitrofurantion | Nitrofurantion | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 71205-171 | Nitrofurantion | Nitrofurantion | Proficient Rx LP | ANDA | Current |
| 71205-171 | Nitrofurantion | Nitrofurantion | Proficient Rx LP | ANDA | Current |
| 71205-171 | Nitrofurantion | Nitrofurantion | Proficient Rx LP | ANDA | Current |
| 71205-171 | Nitrofurantion | Nitrofurantion | Proficient Rx LP | ANDA | Current |
| 71205-171 | Nitrofurantion | Nitrofurantion | Proficient Rx LP | ANDA | Current |
| 71335-0024 | Nitrofurantion | Nitrofurantion | Bryant Ranch Prepack | ANDA | Current |
| 71335-0793 | Nitrofurantion | Nitrofurantion | Bryant Ranch Prepack | ANDA | Current |
| 71335-0793 | Nitrofurantion | Nitrofurantion | Bryant Ranch Prepack | ANDA | Current |
| 71335-0793 | Nitrofurantion | Nitrofurantion | Bryant Ranch Prepack | ANDA | Current |