Application 205180
- Type
- ANDA
- Sponsor
- ACTAVIS MID ATLANTIC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NITROFURANTOIN | NITROFURANTOIN | SUSPENSION;ORAL | 25MG/5ML | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A205180-001 | NITROFURANTOIN | NITROFURANTOIN | 25MG/5ML | SUSPENSION / ORAL | AB | 2016-05-03 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A205180-001 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A205180-001 | NITROFURANTOIN | 25MG/5ML | SUSPENSION / ORAL | AB | 2016-05-03 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A205180-001 | NITROFURANTOIN | 25MG/5ML | SUSPENSION / ORAL | AB | 2016-05-03 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205180-001 | NITROFURANTOIN | 25MG/5ML | SUSPENSION / ORAL | AB | 2016-05-03 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A205180-001 | NITROFURANTOIN | 25MG/5ML | SUSPENSION / ORAL | AB | 2016-05-03 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205180-001 | NITROFURANTOIN | 25MG/5ML | SUSPENSION / ORAL | AB | 2016-05-03 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205180-001 | NITROFURANTOIN | 25MG/5ML | SUSPENSION / ORAL | AB | 2016-05-03 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205180-001 | NITROFURANTOIN | 25MG/5ML | SUSPENSION / ORAL | AB | 2016-05-03 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205180-001 | NITROFURANTOIN | 25MG/5ML | SUSPENSION / ORAL | AB | 2016-05-03 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205180-001 | NITROFURANTOIN | 25MG/5ML | SUSPENSION / ORAL | AB | 2016-05-03 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A205180-001 | NITROFURANTOIN | 25MG/5ML | SUSPENSION / ORAL | AB | 2016-05-03 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A205180-001 | NITROFURANTOIN | 25MG/5ML | SUSPENSION / ORAL | AB | 2016-05-03 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A205180-001 | NITROFURANTOIN | 25MG/5ML | SUSPENSION / ORAL | AB | 2016-05-03 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A205180-001 | NITROFURANTOIN | 25MG/5ML | SUSPENSION / ORAL | AB | 2016-05-03 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A205180-001 | NITROFURANTOIN | 25MG/5ML | SUSPENSION / ORAL | AB | 2016-05-03 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A205180-001 | NITROFURANTOIN | 25MG/5ML | SUSPENSION / ORAL | AB | 2016-05-03 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A205180-001 | NITROFURANTOIN | 25MG/5ML | SUSPENSION / ORAL | AB | 2016-05-03 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A205180-001 | NITROFURANTOIN | 25MG/5ML | SUSPENSION / ORAL | AB | 2016-05-03 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A205180-001 | NITROFURANTOIN | 25MG/5ML | SUSPENSION / ORAL | AB | 2016-05-03 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A205180-001 | NITROFURANTOIN | 25MG/5ML | SUSPENSION / ORAL | AB | 2016-05-03 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A205180-001 | NITROFURANTOIN | 25MG/5ML | SUSPENSION / ORAL | AB | 2016-05-03 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A205180-001 | NITROFURANTOIN | 25MG/5ML | SUSPENSION / ORAL | AB | 2016-05-03 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A205180-001 | NITROFURANTOIN | 25MG/5ML | SUSPENSION / ORAL | AB | 2016-05-03 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A205180-001 | NITROFURANTOIN | 25MG/5ML | SUSPENSION / ORAL | AB | 2016-05-03 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A205180-001 | NITROFURANTOIN | 25MG/5ML | SUSPENSION / ORAL | AB | 2016-05-03 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A205180-001 | NITROFURANTOIN | 25MG/5ML | SUSPENSION / ORAL | AB | 2016-05-03 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A205180-001 | NITROFURANTOIN | 25MG/5ML | SUSPENSION / ORAL | AB | 2016-05-03 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A205180-001 | NITROFURANTOIN | 25MG/5ML | SUSPENSION / ORAL | AB | 2016-05-03 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A205180-001 | NITROFURANTOIN | 25MG/5ML | SUSPENSION / ORAL | AB | 2016-05-03 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A205180-001 | NITROFURANTOIN | 25MG/5ML | SUSPENSION / ORAL | AB | 2016-05-03 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A205180-001 | NITROFURANTOIN | 25MG/5ML | SUSPENSION / ORAL | AB | 2016-05-03 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A205180-001 | NITROFURANTOIN | 25MG/5ML | SUSPENSION / ORAL | AB | 2016-05-03 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A205180-001 | NITROFURANTOIN | 25MG/5ML | SUSPENSION / ORAL | AB | 2016-05-03 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A205180-001 | NITROFURANTOIN | 25MG/5ML | SUSPENSION / ORAL | AB | 2016-05-03 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A205180-001 | NITROFURANTOIN | 25MG/5ML | SUSPENSION / ORAL | AB | 2016-05-03 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A205180-001 | NITROFURANTOIN | 25MG/5ML | SUSPENSION / ORAL | AB | 2016-05-03 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A205180-001 | NITROFURANTOIN | 25MG/5ML | SUSPENSION / ORAL | AB | 2016-05-03 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A205180-001 | NITROFURANTOIN | 25MG/5ML | SUSPENSION / ORAL | AB | 2016-05-03 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A205180-001 | NITROFURANTOIN | 25MG/5ML | SUSPENSION / ORAL | AB | 2016-05-03 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A205180-001 | NITROFURANTOIN | 25MG/5ML | SUSPENSION / ORAL | AB | 2016-05-03 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | A205180-001 | NITROFURANTOIN | 25MG/5ML | SUSPENSION / ORAL | AB | 2016-05-03 | e64feba35796… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A205180-001 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A205180-001 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205180-001 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A205180-001 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205180-001 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205180-001 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205180-001 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205180-001 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205180-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A205180-001 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A205180-001 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A205180-001 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A205180-001 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A205180-001 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A205180-001 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A205180-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A205180-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A205180-001 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A205180-001 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A205180-001 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A205180-001 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A205180-001 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A205180-001 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A205180-001 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A205180-001 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A205180-001 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A205180-001 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A205180-001 | AB | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A205180-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A205180-001 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A205180-001 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A205180-001 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A205180-001 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A205180-001 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A205180-001 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A205180-001 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A205180-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A205180-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A205180-001 | AB | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A205180-001 | AB | 1 | e64feba35796… |
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 | NuCare Pharmaceuticals,Inc. | f40af3e1-e54c-3a35-e053-2a95a90a6cb2 | 2026-08-13 | Warnings, Adverse reactions | Nitrofurantoin NITROFURANTOIN |
| Nitrofurantoin | NITROFURANTOIN | Preferred Pharmaceuticals Inc. | 729f6bbb-ab64-4b65-979a-4ad7605c5947 | 2026-08-04 | Warnings, Adverse reactions | Nitrofurantoin NITROFURANTOIN |
| Nitrofurantoin | NITROFURANTOIN | St. Mary's Medical Park Pharmacy | 09944470-807d-ad37-e063-6394a90a7bfe | 2026-06-23 | Warnings, Adverse reactions | Nitrofurantoin 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 | REMEDYREPACK INC. | 6c82b95d-2c32-4e54-a8a9-a4bb4df70cb5 | 2026-04-15 | Warnings, Adverse reactions | Nitrofurantoin NITROFURANTOIN |
| Nitrofurantoin | NITROFURANTOIN | Somerset Therapeutics, LLC | dd99ba40-edff-47c3-9ee4-7e5b7774e5b5 | 2026-01-22 | Warnings, Adverse reactions | Nitrofurantoin 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 | NITROFURANTOIN | Bryant Ranch Prepack | 1c5db054-58af-4932-8fad-c3883b13f987 | 2025-10-22 | Warnings, Adverse reactions | Nitrofurantoin NITROFURANTOIN |
| Nitrofurantoin | NITROFURANTOIN | PD-Rx Pharmaceuticals, Inc. | d88348a0-6ab4-4490-9325-1f14a541b0a5 | 2025-10-14 | Warnings, Adverse reactions | Nitrofurantoin NITROFURANTOIN |
| Nitrofurantoin | NITROFURANTOIN | PD-Rx Pharmaceuticals, Inc. | 37606c6f-0d85-4314-94ae-f7732c7bc8d5 | 2025-10-09 | Warnings, Adverse reactions | Nitrofurantoin NITROFURANTOIN |
| NITROFURANTOIN | NITROFURANTOIN | REMEDYREPACK INC. | 87505f8f-2056-4e55-adf5-5b7309081d7c | 2025-09-30 | Warnings, Adverse reactions | NITROFURANTOIN NITROFURANTOIN |
| NITROFURANTOIN | NITROFURANTOIN | Proficient Rx LP | 0819be0b-03e9-426e-a4b9-624c32958f94 | 2025-09-01 | Warnings, Adverse reactions | NITROFURANTOIN NITROFURANTOIN |
| NITROFURANTOIN | NITROFURANTOIN | Camber Pharmaceuticals, Inc. | 4e06b31e-cc49-4526-beb6-e77021823aa9 | 2025-08-13 | Warnings, Adverse reactions | NITROFURANTOIN 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 | NITROFURANTOIN | Redpharm Drug, Inc. | f4c2c01d-bef7-3e5d-e053-2995a90ae0d8 | 2025-01-23 | Warnings, Adverse reactions | Nitrofurantoin NITROFURANTOIN |
| NITROFURANTOIN | NITROFURANTOIN | Directrx | d4385368-46d6-8397-e053-2a95a90a8d68 | 2025-01-17 | Warnings, Adverse reactions | NITROFURANTOIN NITROFURANTOIN |
| NITROFURANTOIN | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | Aurobindo Pharma Limited | 788f1fe3-d8a1-42cc-9280-07f842da34ea | 2024-12-18 | Warnings, Adverse reactions | NITROFURANTOIN |