Application 201679

Type: ANDA
Sponsor: AMNEAL PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NITROFURANTOIN	NITROFURANTOIN	SUSPENSION;ORAL	25MG/5ML	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
A201679-001	NITROFURANTOIN	NITROFURANTOIN	25MG/5ML	SUSPENSION / ORAL			2011-05-11

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	A201679-001	NITROFURANTOIN	25MG/5ML	SUSPENSION / ORAL		2011-05-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201679-001	NITROFURANTOIN	25MG/5ML	SUSPENSION / ORAL	AB	2011-05-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201679-001	NITROFURANTOIN	25MG/5ML	SUSPENSION / ORAL	AB	2011-05-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201679-001	NITROFURANTOIN	25MG/5ML	SUSPENSION / ORAL	AB	2011-05-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201679-001	NITROFURANTOIN	25MG/5ML	SUSPENSION / ORAL	AB	2011-05-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201679-001	NITROFURANTOIN	25MG/5ML	SUSPENSION / ORAL	AB	2011-05-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201679-001	NITROFURANTOIN	25MG/5ML	SUSPENSION / ORAL	AB	2011-05-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201679-001	NITROFURANTOIN	25MG/5ML	SUSPENSION / ORAL	AB	2011-05-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201679-001	NITROFURANTOIN	25MG/5ML	SUSPENSION / ORAL	AB	2011-05-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201679-001	NITROFURANTOIN	25MG/5ML	SUSPENSION / ORAL	AB	2011-05-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201679-001	NITROFURANTOIN	25MG/5ML	SUSPENSION / ORAL	AB	2011-05-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201679-001	NITROFURANTOIN	25MG/5ML	SUSPENSION / ORAL	AB	2011-05-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201679-001	NITROFURANTOIN	25MG/5ML	SUSPENSION / ORAL	AB	2011-05-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201679-001	NITROFURANTOIN	25MG/5ML	SUSPENSION / ORAL	AB	2011-05-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201679-001	NITROFURANTOIN	25MG/5ML	SUSPENSION / ORAL	AB	2011-05-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201679-001	NITROFURANTOIN	25MG/5ML	SUSPENSION / ORAL	AB	2011-05-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201679-001	NITROFURANTOIN	25MG/5ML	SUSPENSION / ORAL	AB	2011-05-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201679-001	NITROFURANTOIN	25MG/5ML	SUSPENSION / ORAL	AB	2011-05-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201679-001	NITROFURANTOIN	25MG/5ML	SUSPENSION / ORAL	AB	2011-05-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201679-001	NITROFURANTOIN	25MG/5ML	SUSPENSION / ORAL	AB	2011-05-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201679-001	NITROFURANTOIN	25MG/5ML	SUSPENSION / ORAL	AB	2011-05-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201679-001	NITROFURANTOIN	25MG/5ML	SUSPENSION / ORAL	AB	2011-05-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201679-001	NITROFURANTOIN	25MG/5ML	SUSPENSION / ORAL	AB	2011-05-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201679-001	NITROFURANTOIN	25MG/5ML	SUSPENSION / ORAL	AB	2011-05-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201679-001	NITROFURANTOIN	25MG/5ML	SUSPENSION / ORAL	AB	2011-05-11	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201679-001	NITROFURANTOIN	25MG/5ML	SUSPENSION / ORAL	AB	2011-05-11	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201679-001	NITROFURANTOIN	25MG/5ML	SUSPENSION / ORAL	AB	2011-05-11	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201679-001	NITROFURANTOIN	25MG/5ML	SUSPENSION / ORAL	AB	2011-05-11	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201679-001	NITROFURANTOIN	25MG/5ML	SUSPENSION / ORAL	AB	2011-05-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A201679-001	NITROFURANTOIN	25MG/5ML	SUSPENSION / ORAL	AB	2011-05-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A201679-001	NITROFURANTOIN	25MG/5ML	SUSPENSION / ORAL	AB	2011-05-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201679-001	NITROFURANTOIN	25MG/5ML	SUSPENSION / ORAL		2011-05-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201679-001	NITROFURANTOIN	25MG/5ML	SUSPENSION / ORAL		2011-05-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201679-001	NITROFURANTOIN	25MG/5ML	SUSPENSION / ORAL		2011-05-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201679-001	NITROFURANTOIN	25MG/5ML	SUSPENSION / ORAL		2011-05-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A201679-001	NITROFURANTOIN	25MG/5ML	SUSPENSION / ORAL		2011-05-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A201679-001	NITROFURANTOIN	25MG/5ML	SUSPENSION / ORAL		2011-05-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A201679-001	NITROFURANTOIN	25MG/5ML	SUSPENSION / ORAL		2011-05-11	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A201679-001	NITROFURANTOIN	25MG/5ML	SUSPENSION / ORAL		2011-05-11	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A201679-001	NITROFURANTOIN	25MG/5ML	SUSPENSION / ORAL		2011-05-11	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A201679-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201679-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201679-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201679-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201679-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201679-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201679-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201679-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201679-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201679-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201679-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201679-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201679-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201679-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201679-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201679-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201679-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201679-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201679-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201679-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201679-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201679-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201679-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201679-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201679-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201679-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201679-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201679-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A201679-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A201679-001	AB	1	`ea1830bbd6c7…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A201679-001	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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nitrofurantoin	NITROFURANTOIN	Amneal Pharmaceuticals LLC	11dcea9c-0c62-4153-976b-bd1f8ef1f6d9	2024-10-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201679 application number: ANDA201679 ndc (product): 65162-689
Nitrofurantoin	NITROFURANTOIN	Amneal Pharmaceuticals NY LLC	80129dba-5939-4292-bfd0-8d53ba165941	2024-02-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201679 application number: ANDA201679

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
65162-689	Nitrofurantoin	Nitrofurantoin	Amneal Pharmaceuticals LLC	ANDA	Current
65162-689	Nitrofurantoin	Nitrofurantoin	Amneal Pharmaceuticals LLC	ANDA	Current
65162-689	Nitrofurantoin	Nitrofurantoin	Amneal Pharmaceuticals LLC	ANDA	Current
65162-689	Nitrofurantoin	Nitrofurantoin	Amneal Pharmaceuticals LLC	ANDA	Current
65162-689	Nitrofurantoin	Nitrofurantoin	Amneal Pharmaceuticals LLC	ANDA	Current