Application 207372

Type: ANDA
Sponsor: AMNEAL PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE	CAPSULE;ORAL	75MG;25MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A207372-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE	75MG;25MG	CAPSULE / ORAL			2017-05-15

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.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A207372-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL		2017-05-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207372-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL		2017-05-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207372-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL		2017-05-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207372-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL		2017-05-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207372-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2017-05-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207372-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2017-05-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207372-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2017-05-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207372-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2017-05-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207372-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2017-05-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207372-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2017-05-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207372-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2017-05-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207372-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2017-05-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207372-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2017-05-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207372-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2017-05-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207372-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2017-05-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207372-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2017-05-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207372-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2017-05-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207372-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2017-05-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207372-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2017-05-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207372-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2017-05-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207372-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2017-05-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207372-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2017-05-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207372-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2017-05-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207372-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2017-05-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207372-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2017-05-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207372-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2017-05-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207372-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2017-05-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207372-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2017-05-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207372-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2017-05-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207372-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2017-05-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207372-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2017-05-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207372-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2017-05-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207372-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2017-05-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207372-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2017-05-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207372-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2017-05-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207372-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2017-05-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207372-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2017-05-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207372-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2017-05-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207372-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2017-05-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207372-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2017-05-15	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207372-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207372-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207372-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207372-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207372-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207372-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207372-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207372-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207372-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207372-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207372-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207372-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207372-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207372-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207372-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207372-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207372-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207372-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207372-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207372-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207372-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207372-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207372-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207372-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207372-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207372-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207372-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207372-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207372-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207372-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207372-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207372-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207372-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207372-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207372-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207372-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207372-001	AB	1	`cb3db0bc1861…`

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nitrofurantoin (monohydrate/macrocrystals)	NITROFURANTOIN MONOHYDRATE/MACROCRYSTALS	Amneal Pharmaceuticals LLC	55c75f27-b5fc-4f19-8607-08f8ec0c69ec	2024-10-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207372 application number: ANDA207372 ndc (product): 65162-478

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 37 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42291-574	Nitrofurantoin	Nitrofurantoin monohydrate/macrocrystals	AvKARE, Inc.	ANDA	Current
42291-574	Nitrofurantoin	Nitrofurantoin monohydrate/macrocrystals	AvKARE	ANDA	Current
50090-4570	Nitrofurantoin	Nitrofurantoin monohydrate/macrocrystals	A-S Medication Solutions	ANDA	Current
50090-4570	Nitrofurantoin	Nitrofurantoin monohydrate/macrocrystals	A-S Medication Solutions	ANDA	Current
50090-4591	Nitrofurantoin	Nitrofurantoin monohydrate/macrocrystals	A-S Medication Solutions	ANDA	Current
50090-4591	Nitrofurantoin	Nitrofurantoin monohydrate/macrocrystals	A-S Medication Solutions	ANDA	Current
50268-625	Nitrofurantoin	Nitrofurantoin monohydrate/macrocrystals	AvPAK	ANDA	Current
50268-625	Nitrofurantoin	Nitrofurantoin monohydrate/macrocrystals	AvPAK	ANDA	Current
53002-7042	Nitrofurantoin	Nitrofurantoin monohydrate/macrocrystals	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-7042	Nitrofurantoin	Nitrofurantoin monohydrate/macrocrystals	RPK Pharmaceuticals, Inc.	ANDA	Current
55700-794	Nitrofurantoin	Nitrofurantoin monohydrate/macrocrystals	Quality Care Products, LLC	ANDA	Current
55700-794	Nitrofurantoin	Nitrofurantoin monohydrate/macrocrystals	Quality Care Products, LLC	ANDA	Current
60687-633	Nitrofurantoin	Nitrofurantoin monohydrate/macrocrystals	American Health Packaging	ANDA	Current
60760-478	Nitrofurantoin	Nitrofurantoin monohydrate/macrocrystals	St. Mary's Medical Park Pharmacy	ANDA	Current
65162-478	Nitrofurantoin	Nitrofurantoin monohydrate/macrocrystals	Amneal Pharmaceuticals LLC	ANDA	Current
65162-478	Nitrofurantoin	Nitrofurantoin monohydrate/macrocrystals	Amneal Pharmaceuticals LLC	ANDA	Current
65162-478	Nitrofurantoin	Nitrofurantoin monohydrate/macrocrystals	Amneal Pharmaceuticals LLC	ANDA	Current
65162-478	Nitrofurantoin	Nitrofurantoin monohydrate/macrocrystals	Amneal Pharmaceuticals LLC	ANDA	Current
65162-478	Nitrofurantoin	Nitrofurantoin monohydrate/macrocrystals	Amneal Pharmaceuticals LLC	ANDA	Current
67296-1640	Nitrofurantoin	Nitrofurantoin monohydrate/macrocrystals	RedPharm Drug, Inc.	ANDA	Current
67296-1640	Nitrofurantoin	Nitrofurantoin monohydrate/macrocrystals	RedPharm Drug, Inc.	ANDA	Current
68071-4531	Nitrofurantoin	Nitrofurantoin monohydrate/macrocrystals	NuCare Pharmaceuticals,In	ANDA	Current
68071-4531	Nitrofurantoin	Nitrofurantoin monohydrate/macrocrystals	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4531	Nitrofurantoin	Nitrofurantoin monohydrate/macrocrystals	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4535	Nitrofurantoin monohydrate/macrocrystals	Nitrofurantoin monohydrate/macrocrystals	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4535	Nitrofurantoin monohydrate/macrocrystals	Nitrofurantoin monohydrate/macrocrystals	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4535	Nitrofurantoin monohydrate/macrocrystals	Nitrofurantoin monohydrate/macrocrystals	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-7276	Nitrofurantoin	Nitrofurantoin monohydrate/macrocrystals	Preferred Pharmaceuticals, Inc.	ANDA	Current
70518-0799	Nitrofurantoin	Nitrofurantoin monohydrate/macrocrystals	REMEDYREPACK INC.	ANDA	Current
70518-0799	Nitrofurantoin	Nitrofurantoin monohydrate/macrocrystals	REMEDYREPACK INC.	ANDA	Current
70934-129	Nitrofurantoin	Nitrofurantoin monohydrate/macrocrystals	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-129	Nitrofurantoin	Nitrofurantoin monohydrate/macrocrystals	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-129	Nitrofurantoin	Nitrofurantoin monohydrate/macrocrystals	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
71335-0863	Nitrofurantoin	Nitrofurantoin monohydrate/macrocrystals	Bryant Ranch Prepack	ANDA	Current
71335-0863	Nitrofurantoin	Nitrofurantoin monohydrate/macrocrystals	Bryant Ranch Prepack	ANDA	Current
71335-0863	Nitrofurantoin	Nitrofurantoin monohydrate/macrocrystals	Bryant Ranch Prepack	ANDA	Current
71335-0863	Nitrofurantoin	Nitrofurantoin monohydrate/macrocrystals	Bryant Ranch Prepack	ANDA	Current