Application 074336
- Type
- ANDA
- Sponsor
- INVATECH
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 |
|---|---|---|---|---|---|---|---|
| A074336-001 | NITROFURANTOIN | NITROFURANTOIN, MACROCRYSTALLINE | 25MG | CAPSULE / ORAL | 1995-01-25 | ||
| A074336-002 | NITROFURANTOIN | NITROFURANTOIN, MACROCRYSTALLINE | 50MG | CAPSULE / ORAL | 1995-01-25 | ||
| A074336-003 | NITROFURANTOIN | NITROFURANTOIN, MACROCRYSTALLINE | 100MG | CAPSULE / ORAL | 1995-01-25 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A074336-002 | NITROFURANTOIN | 50MG | CAPSULE / ORAL | 1995-01-25 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A074336-003 | NITROFURANTOIN | 100MG | CAPSULE / ORAL | 1995-01-25 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A074336-001 | NITROFURANTOIN | 25MG | CAPSULE / ORAL | 1995-01-25 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A074336-002 | NITROFURANTOIN | 50MG | CAPSULE / ORAL | 1995-01-25 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A074336-003 | NITROFURANTOIN | 100MG | CAPSULE / ORAL | 1995-01-25 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A074336-001 | NITROFURANTOIN | 25MG | CAPSULE / ORAL | 1995-01-25 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A074336-002 | NITROFURANTOIN | 50MG | CAPSULE / ORAL | 1995-01-25 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A074336-003 | NITROFURANTOIN | 100MG | CAPSULE / ORAL | 1995-01-25 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A074336-001 | NITROFURANTOIN | 25MG | CAPSULE / ORAL | 1995-01-25 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A074336-002 | NITROFURANTOIN | 50MG | CAPSULE / ORAL | 1995-01-25 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A074336-003 | NITROFURANTOIN | 100MG | CAPSULE / ORAL | 1995-01-25 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A074336-001 | NITROFURANTOIN | 25MG | CAPSULE / ORAL | 1995-01-25 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A074336-002 | NITROFURANTOIN | 50MG | CAPSULE / ORAL | 1995-01-25 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A074336-003 | NITROFURANTOIN | 100MG | CAPSULE / ORAL | 1995-01-25 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A074336-001 | NITROFURANTOIN | 25MG | CAPSULE / ORAL | 1995-01-25 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A074336-002 | NITROFURANTOIN | 50MG | CAPSULE / ORAL | 1995-01-25 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A074336-003 | NITROFURANTOIN | 100MG | CAPSULE / ORAL | 1995-01-25 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A074336-001 | NITROFURANTOIN | 25MG | CAPSULE / ORAL | 1995-01-25 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A074336-002 | NITROFURANTOIN | 50MG | CAPSULE / ORAL | 1995-01-25 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A074336-003 | NITROFURANTOIN | 100MG | CAPSULE / ORAL | 1995-01-25 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A074336-001 | NITROFURANTOIN | 25MG | CAPSULE / ORAL | 1995-01-25 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A074336-002 | NITROFURANTOIN | 50MG | CAPSULE / ORAL | 1995-01-25 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A074336-003 | NITROFURANTOIN | 100MG | CAPSULE / ORAL | 1995-01-25 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A074336-001 | NITROFURANTOIN | 25MG | CAPSULE / ORAL | 1995-01-25 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A074336-002 | NITROFURANTOIN | 50MG | CAPSULE / ORAL | 1995-01-25 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A074336-003 | NITROFURANTOIN | 100MG | CAPSULE / ORAL | 1995-01-25 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A074336-001 | NITROFURANTOIN | 25MG | CAPSULE / ORAL | 1995-01-25 | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A074336-002 | NITROFURANTOIN | 50MG | CAPSULE / ORAL | 1995-01-25 | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A074336-003 | NITROFURANTOIN | 100MG | CAPSULE / ORAL | 1995-01-25 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A074336-001 | NITROFURANTOIN | 25MG | CAPSULE / ORAL | 1995-01-25 | 87673890dc5c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A074336-002 | NITROFURANTOIN | 50MG | CAPSULE / ORAL | 1995-01-25 | 87673890dc5c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A074336-003 | NITROFURANTOIN | 100MG | CAPSULE / ORAL | 1995-01-25 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A074336-001 | NITROFURANTOIN | 25MG | CAPSULE / ORAL | 1995-01-25 | 5aa47cf7b7d7… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A074336-002 | NITROFURANTOIN | 50MG | CAPSULE / ORAL | 1995-01-25 | 5aa47cf7b7d7… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A074336-003 | NITROFURANTOIN | 100MG | CAPSULE / ORAL | 1995-01-25 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A074336-001 | NITROFURANTOIN | 25MG | CAPSULE / ORAL | 1995-01-25 | 8869cabd3fbd… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A074336-002 | NITROFURANTOIN | 50MG | CAPSULE / ORAL | 1995-01-25 | 8869cabd3fbd… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A074336-003 | NITROFURANTOIN | 100MG | CAPSULE / ORAL | 1995-01-25 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A074336-001 | NITROFURANTOIN | 25MG | CAPSULE / ORAL | 1995-01-25 | c0c555d07b60… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A074336-002 | NITROFURANTOIN | 50MG | CAPSULE / ORAL | 1995-01-25 | c0c555d07b60… |
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 | NITROFURANTOIN | REMEDYREPACK INC. | 87505f8f-2056-4e55-adf5-5b7309081d7c | 2026-09-01 | Warnings, Adverse reactions | NITROFURANTOIN |
| Nitrofurantoin | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | NuCare Pharmaceuticals,Inc. | 10e2503d-a250-996f-e063-6294a90abd61 | 2026-08-19 | Warnings, Adverse reactions | Nitrofurantoin |
| Nitrofurantoin | NITROFURANTOIN | REMEDYREPACK INC. | 6c82b95d-2c32-4e54-a8a9-a4bb4df70cb5 | 2026-08-19 | Warnings, Adverse reactions | Nitrofurantoin |
| Nitrofurantoin | NITROFURANTOIN | Preferred Pharmaceuticals Inc. | 729f6bbb-ab64-4b65-979a-4ad7605c5947 | 2026-08-04 | Warnings, Adverse reactions | Nitrofurantoin |
| Nitrofurantoin | NITROFURANTOIN | St. Mary's Medical Park Pharmacy | 09944470-807d-ad37-e063-6394a90a7bfe | 2026-06-23 | Warnings, Adverse reactions | Nitrofurantoin |
| NITROFURANTOIN | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | A-S Medication Solutions | b6c5bbb0-86db-4a76-a1eb-98573a0b0adc | 2026-06-10 | Warnings, Adverse reactions | NITROFURANTOIN |
| NITROFURANTOIN | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | Bryant Ranch Prepack | 8450fee6-7b9d-4c74-848e-c4f42c1963f9 | 2026-04-20 | Warnings, Adverse reactions | NITROFURANTOIN |
| Nitrofurantoin | NITROFURANTOIN | Somerset Therapeutics, LLC | dd99ba40-edff-47c3-9ee4-7e5b7774e5b5 | 2026-01-22 | Warnings, Adverse reactions | Nitrofurantoin |
| NITROFURANTOIN | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | A-S Medication Solutions | 2a772eb3-4fb3-4d92-b9f4-469dd2216361 | 2026-01-06 | Warnings, Adverse reactions | NITROFURANTOIN |
| Nitrofurantoin | NITROFURANTOIN | Rising Pharma Holdings, Inc. | 89095f4d-e142-465e-b378-da24f6eeaf2b | 2025-11-11 | Warnings, Adverse reactions | Nitrofurantoin |
| Nitrofurantoin | NITROFURANTOIN | Bryant Ranch Prepack | 1c5db054-58af-4932-8fad-c3883b13f987 | 2025-10-22 | Warnings, Adverse reactions | Nitrofurantoin |
| Nitrofurantoin | NITROFURANTOIN | PD-Rx Pharmaceuticals, Inc. | d88348a0-6ab4-4490-9325-1f14a541b0a5 | 2025-10-14 | Warnings, Adverse reactions | Nitrofurantoin |
| Nitrofurantoin | NITROFURANTOIN | PD-Rx Pharmaceuticals, Inc. | 37606c6f-0d85-4314-94ae-f7732c7bc8d5 | 2025-10-09 | Warnings, Adverse reactions | Nitrofurantoin |
| NITROFURANTOIN | NITROFURANTOIN | Proficient Rx LP | 0819be0b-03e9-426e-a4b9-624c32958f94 | 2025-09-01 | Warnings, Adverse reactions | NITROFURANTOIN |
| NITROFURANTOIN | NITROFURANTOIN | Camber Pharmaceuticals, Inc. | 4e06b31e-cc49-4526-beb6-e77021823aa9 | 2025-08-13 | Warnings, Adverse reactions | NITROFURANTOIN |
| Nitrofurantoin | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | A-S Medication Solutions | b644426c-c8ba-4fe0-80c7-d9b2dde37395 | 2025-08-13 | Warnings, Adverse reactions | Nitrofurantoin |
| Nitrofurantoin | NITROFURANTOIN | Micro Labs Limited | d96098d0-3c2b-4e53-a3f0-3ebba81c4133 | 2025-05-14 | Warnings, Adverse reactions | Nitrofurantoin |
| Nitrofurantoin | NITROFURANTOIN | Redpharm Drug, Inc. | f4c2c01d-bef7-3e5d-e053-2995a90ae0d8 | 2025-01-23 | Warnings, Adverse reactions | Nitrofurantoin |
| NITROFURANTOIN | NITROFURANTOIN | Directrx | d4385368-46d6-8397-e053-2a95a90a8d68 | 2025-01-17 | Warnings, Adverse reactions | NITROFURANTOIN |
| NITROFURANTOIN | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | Aurobindo Pharma Limited | 788f1fe3-d8a1-42cc-9280-07f842da34ea | 2024-12-18 | Warnings, Adverse reactions | NITROFURANTOIN |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.