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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A074336-001 | NITROFURANTOIN | 25MG | CAPSULE / ORAL | 1995-01-25 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A074336-002 | NITROFURANTOIN | 50MG | CAPSULE / ORAL | 1995-01-25 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A074336-003 | NITROFURANTOIN | 100MG | CAPSULE / ORAL | 1995-01-25 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A074336-001 | NITROFURANTOIN | 25MG | CAPSULE / ORAL | 1995-01-25 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A074336-002 | NITROFURANTOIN | 50MG | CAPSULE / ORAL | 1995-01-25 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A074336-003 | NITROFURANTOIN | 100MG | CAPSULE / ORAL | 1995-01-25 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A074336-001 | NITROFURANTOIN | 25MG | CAPSULE / ORAL | 1995-01-25 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A074336-002 | NITROFURANTOIN | 50MG | CAPSULE / ORAL | 1995-01-25 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A074336-003 | NITROFURANTOIN | 100MG | CAPSULE / ORAL | 1995-01-25 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074336-001 | NITROFURANTOIN | 25MG | CAPSULE / ORAL | 1995-01-25 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074336-002 | NITROFURANTOIN | 50MG | CAPSULE / ORAL | 1995-01-25 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074336-003 | NITROFURANTOIN | 100MG | CAPSULE / ORAL | 1995-01-25 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A074336-001 | NITROFURANTOIN | 25MG | CAPSULE / ORAL | 1995-01-25 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A074336-002 | NITROFURANTOIN | 50MG | CAPSULE / ORAL | 1995-01-25 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A074336-003 | NITROFURANTOIN | 100MG | CAPSULE / ORAL | 1995-01-25 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074336-001 | NITROFURANTOIN | 25MG | CAPSULE / ORAL | 1995-01-25 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074336-002 | NITROFURANTOIN | 50MG | CAPSULE / ORAL | 1995-01-25 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074336-003 | NITROFURANTOIN | 100MG | CAPSULE / ORAL | 1995-01-25 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074336-001 | NITROFURANTOIN | 25MG | CAPSULE / ORAL | 1995-01-25 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074336-002 | NITROFURANTOIN | 50MG | CAPSULE / ORAL | 1995-01-25 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074336-003 | NITROFURANTOIN | 100MG | CAPSULE / ORAL | 1995-01-25 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074336-001 | NITROFURANTOIN | 25MG | CAPSULE / ORAL | 1995-01-25 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074336-002 | NITROFURANTOIN | 50MG | CAPSULE / ORAL | 1995-01-25 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074336-003 | NITROFURANTOIN | 100MG | CAPSULE / ORAL | 1995-01-25 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074336-001 | NITROFURANTOIN | 25MG | CAPSULE / ORAL | 1995-01-25 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074336-002 | NITROFURANTOIN | 50MG | CAPSULE / ORAL | 1995-01-25 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074336-003 | NITROFURANTOIN | 100MG | CAPSULE / ORAL | 1995-01-25 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074336-001 | NITROFURANTOIN | 25MG | CAPSULE / ORAL | 1995-01-25 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074336-002 | NITROFURANTOIN | 50MG | CAPSULE / ORAL | 1995-01-25 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074336-003 | NITROFURANTOIN | 100MG | CAPSULE / ORAL | 1995-01-25 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A074336-001 | NITROFURANTOIN | 25MG | CAPSULE / ORAL | 1995-01-25 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A074336-002 | NITROFURANTOIN | 50MG | CAPSULE / ORAL | 1995-01-25 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A074336-003 | NITROFURANTOIN | 100MG | CAPSULE / ORAL | 1995-01-25 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A074336-001 | NITROFURANTOIN | 25MG | CAPSULE / ORAL | 1995-01-25 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A074336-002 | NITROFURANTOIN | 50MG | CAPSULE / ORAL | 1995-01-25 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A074336-003 | NITROFURANTOIN | 100MG | CAPSULE / ORAL | 1995-01-25 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A074336-001 | NITROFURANTOIN | 25MG | CAPSULE / ORAL | 1995-01-25 | 79d66fd596c7… | ||
| 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… |
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 | Biocon Pharma Inc | 68c718a7-2e8f-288c-37d2-053372ee61b9 | 2024-11-14 | Warnings, Adverse reactions | NITROFURANTOIN |
| Nitrofurantoin | NITROFURANTOIN | Amneal Pharmaceuticals LLC | 11dcea9c-0c62-4153-976b-bd1f8ef1f6d9 | 2024-10-30 | Warnings, Adverse reactions | Nitrofurantoin |
| Nitrofurantoin | NITROFURANTOIN | ANI Pharmaceuticals, Inc. | 3b377aff-2d4b-43ea-84c9-8e72c1421b7b | 2024-10-08 | Warnings, Adverse reactions | Nitrofurantoin |
| Nitrofurantoin | NITROFURANTOIN | Bryant Ranch Prepack | 56e07ad3-7224-4aaf-9a68-0d48d4abfec8 | 2024-08-28 | Warnings, Adverse reactions | Nitrofurantoin |
| nitrofurantoin | NITROFURANTOIN MACROCRYSTALS | A-S Medication Solutions | 4cd9e234-a2b9-4201-b8f8-cf37c0672de7 | 2024-08-15 | Warnings, Adverse reactions | nitrofurantoin |
| nitrofurantoin | NITROFURANTOIN MACROCRYSTALS | Bryant Ranch Prepack | aca04d52-8a64-4fca-94b2-64b46f5a3218 | 2024-05-17 | Warnings, Adverse reactions | nitrofurantoin |
| Nitrofurantoin | NITROFURANTOIN | Rising Pharma Holdings, Inc. | 11e700aa-66f9-4939-8a6b-a23240ae1a0b | 2024-05-16 | Warnings, Adverse reactions | Nitrofurantoin |
| Nitrofurantoin | NITROFURANTOIN MACROCRYSTALS | Bryant Ranch Prepack | c335f76b-6b85-4c9f-bbfa-95514cdd80fa | 2024-04-08 | Warnings, Adverse reactions | Nitrofurantoin |
| Nitrofurantoin | NITROFURANTOIN | NorthStar Rx LLC | 04af8b73-7e15-7da8-e063-6294a90af284 | 2024-03-29 | Warnings, Adverse reactions | Nitrofurantoin |
| Nitrofurantoin | NITROFURANTOIN | Aurobindo Pharma Limited | e9d10eaa-cf9c-469e-82ef-5af7285f2c86 | 2024-03-15 | Warnings, Adverse reactions | Nitrofurantoin |
| Nitrofurantoin | NITROFURANTOIN | Bryant Ranch Prepack | bebbe5d6-f6ec-4191-bad3-b6e933da0688 | 2024-03-15 | Warnings, Adverse reactions | Nitrofurantoin |
| Nitrofurantoin | NITROFURANTOIN | Amneal Pharmaceuticals NY LLC | 80129dba-5939-4292-bfd0-8d53ba165941 | 2024-02-26 | Warnings, Adverse reactions | Nitrofurantoin |
| Nitrofurantoin | NITROFURANTOIN | Bryant Ranch Prepack | 75dab97e-59b4-447c-a8c9-b4d5a970098f | 2024-01-04 | Warnings, Adverse reactions | Nitrofurantoin |
| Nitrofurantoin | NITROFURANTOIN | Bryant Ranch Prepack | b807bd48-71ab-4578-b1d7-4d3260bf6c75 | 2023-10-02 | Warnings, Adverse reactions | Nitrofurantoin |
| Nitrofurantoin | NITROFURANTOIN | Trigen Laboratories, LLC | 39ffb8c6-4dd8-4436-b857-7306c15f662a | 2023-05-11 | Warnings, Adverse reactions | Nitrofurantoin |
| NITROFURANTOIN | NITROFURANTOIN | Alembic Pharmaceuticals Inc. | a8a0d7d7-1e18-46a7-a1f8-e97499820035 | 2023-05-05 | Warnings, Adverse reactions | NITROFURANTOIN |
| NITROFURANTOIN | NITROFURANTOIN | Alembic Pharmaceuticals Limited | 152e4fe2-7665-4725-af76-b241bd816937 | 2023-01-30 | Warnings, Adverse reactions | NITROFURANTOIN |
| Nitrofurantoin | NITROFURANTOIN | Proficient Rx LP | 34d3c103-27b8-454b-9f38-c33157c3b6fc | 2022-11-01 | Warnings, Adverse reactions | Nitrofurantoin |
| Nitrofurantoin | NITROFURANTOIN | Lupin Pharmaceuticals,Inc. | 93c37857-38f1-4e2e-acb8-4846840e3e85 | 2022-06-02 | Warnings, Adverse reactions | Nitrofurantoin |
| Nitrofurantoin | NITROFURANTOIN | Novel Laboratories, Inc. | 499f9dfd-b533-4021-a3ed-308f0f956c79 | 2016-11-14 | Warnings, Adverse reactions | Nitrofurantoin |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.