Application 080043

Type: ANDA
Sponsor: SANDOZ

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NITROFURANTOIN	NITROFURANTOIN	TABLET;ORAL	50MG	No	No
002	NITROFURANTOIN	NITROFURANTOIN	TABLET;ORAL	100MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A080043-001	NITROFURANTOIN	NITROFURANTOIN	50MG	TABLET / ORAL		Approved before 1982
A080043-002	NITROFURANTOIN	NITROFURANTOIN	100MG	TABLET / ORAL		Approved before 1982

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 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2026-09-14 22:38:34	2026-08	A080043-001	NITROFURANTOIN	50MG	TABLET / ORAL	Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A080043-002	NITROFURANTOIN	100MG	TABLET / ORAL	Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A080043-001	NITROFURANTOIN	50MG	TABLET / ORAL	Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A080043-002	NITROFURANTOIN	100MG	TABLET / ORAL	Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A080043-001	NITROFURANTOIN	50MG	TABLET / ORAL	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A080043-002	NITROFURANTOIN	100MG	TABLET / ORAL	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A080043-001	NITROFURANTOIN	50MG	TABLET / ORAL	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A080043-002	NITROFURANTOIN	100MG	TABLET / ORAL	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A080043-001	NITROFURANTOIN	50MG	TABLET / ORAL	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A080043-002	NITROFURANTOIN	100MG	TABLET / ORAL	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A080043-001	NITROFURANTOIN	50MG	TABLET / ORAL	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A080043-002	NITROFURANTOIN	100MG	TABLET / ORAL	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A080043-001	NITROFURANTOIN	50MG	TABLET / ORAL	Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A080043-002	NITROFURANTOIN	100MG	TABLET / ORAL	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A080043-001	NITROFURANTOIN	50MG	TABLET / ORAL	Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A080043-002	NITROFURANTOIN	100MG	TABLET / ORAL	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A080043-001	NITROFURANTOIN	50MG	TABLET / ORAL	Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A080043-002	NITROFURANTOIN	100MG	TABLET / ORAL	Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A080043-001	NITROFURANTOIN	50MG	TABLET / ORAL	Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A080043-002	NITROFURANTOIN	100MG	TABLET / ORAL	Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A080043-001	NITROFURANTOIN	50MG	TABLET / ORAL	Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A080043-002	NITROFURANTOIN	100MG	TABLET / ORAL	Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A080043-001	NITROFURANTOIN	50MG	TABLET / ORAL	Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A080043-002	NITROFURANTOIN	100MG	TABLET / ORAL	Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A080043-001	NITROFURANTOIN	50MG	TABLET / ORAL	Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A080043-002	NITROFURANTOIN	100MG	TABLET / ORAL	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A080043-001	NITROFURANTOIN	50MG	TABLET / ORAL	Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A080043-002	NITROFURANTOIN	100MG	TABLET / ORAL	Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A080043-001	NITROFURANTOIN	50MG	TABLET / ORAL	Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A080043-002	NITROFURANTOIN	100MG	TABLET / ORAL	Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A080043-001	NITROFURANTOIN	50MG	TABLET / ORAL	Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A080043-002	NITROFURANTOIN	100MG	TABLET / ORAL	Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A080043-001	NITROFURANTOIN	50MG	TABLET / ORAL	Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A080043-002	NITROFURANTOIN	100MG	TABLET / ORAL	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A080043-001	NITROFURANTOIN	50MG	TABLET / ORAL	Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A080043-002	NITROFURANTOIN	100MG	TABLET / ORAL	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A080043-001	NITROFURANTOIN	50MG	TABLET / ORAL	Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A080043-002	NITROFURANTOIN	100MG	TABLET / ORAL	Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A080043-001	NITROFURANTOIN	50MG	TABLET / ORAL	Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A080043-002	NITROFURANTOIN	100MG	TABLET / ORAL	Approved before 1982	`74a2ff9319b5…`

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 2 of 2 · 40 matching rows.

Brand, Generic, Manufacturer table
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	Name fallback brand name: NITROFURANTOIN generic name: NITROFURANTOIN
Nitrofurantoin	NITROFURANTOIN	Amneal Pharmaceuticals LLC	11dcea9c-0c62-4153-976b-bd1f8ef1f6d9	2024-10-30	Warnings, Adverse reactions	Name fallback brand name: Nitrofurantoin generic name: NITROFURANTOIN
Nitrofurantoin	NITROFURANTOIN	ANI Pharmaceuticals, Inc.	3b377aff-2d4b-43ea-84c9-8e72c1421b7b	2024-10-08	Warnings, Adverse reactions	Name fallback brand name: Nitrofurantoin generic name: NITROFURANTOIN
Nitrofurantoin	NITROFURANTOIN	Bryant Ranch Prepack	56e07ad3-7224-4aaf-9a68-0d48d4abfec8	2024-08-28	Warnings, Adverse reactions	Name fallback brand name: Nitrofurantoin generic name: NITROFURANTOIN
nitrofurantoin	NITROFURANTOIN MACROCRYSTALS	A-S Medication Solutions	4cd9e234-a2b9-4201-b8f8-cf37c0672de7	2024-08-15	Warnings, Adverse reactions	Name fallback brand name: nitrofurantoin
nitrofurantoin	NITROFURANTOIN MACROCRYSTALS	Bryant Ranch Prepack	aca04d52-8a64-4fca-94b2-64b46f5a3218	2024-05-17	Warnings, Adverse reactions	Name fallback brand name: nitrofurantoin
Nitrofurantoin	NITROFURANTOIN	Rising Pharma Holdings, Inc.	11e700aa-66f9-4939-8a6b-a23240ae1a0b	2024-05-16	Warnings, Adverse reactions	Name fallback brand name: Nitrofurantoin generic name: NITROFURANTOIN
Nitrofurantoin	NITROFURANTOIN MACROCRYSTALS	Bryant Ranch Prepack	c335f76b-6b85-4c9f-bbfa-95514cdd80fa	2024-04-08	Warnings, Adverse reactions	Name fallback brand name: Nitrofurantoin
Nitrofurantoin	NITROFURANTOIN	NorthStar Rx LLC	04af8b73-7e15-7da8-e063-6294a90af284	2024-03-29	Warnings, Adverse reactions	Name fallback brand name: Nitrofurantoin generic name: NITROFURANTOIN
Nitrofurantoin	NITROFURANTOIN	Aurobindo Pharma Limited	e9d10eaa-cf9c-469e-82ef-5af7285f2c86	2024-03-15	Warnings, Adverse reactions	Name fallback brand name: Nitrofurantoin generic name: NITROFURANTOIN
Nitrofurantoin	NITROFURANTOIN	Bryant Ranch Prepack	bebbe5d6-f6ec-4191-bad3-b6e933da0688	2024-03-15	Warnings, Adverse reactions	Name fallback brand name: Nitrofurantoin generic name: NITROFURANTOIN
Nitrofurantoin	NITROFURANTOIN	Amneal Pharmaceuticals NY LLC	80129dba-5939-4292-bfd0-8d53ba165941	2024-02-26	Warnings, Adverse reactions	Name fallback brand name: Nitrofurantoin generic name: NITROFURANTOIN
Nitrofurantoin	NITROFURANTOIN	Bryant Ranch Prepack	75dab97e-59b4-447c-a8c9-b4d5a970098f	2024-01-04	Warnings, Adverse reactions	Name fallback brand name: Nitrofurantoin generic name: NITROFURANTOIN
Nitrofurantoin	NITROFURANTOIN	Bryant Ranch Prepack	b807bd48-71ab-4578-b1d7-4d3260bf6c75	2023-10-02	Warnings, Adverse reactions	Name fallback brand name: Nitrofurantoin generic name: NITROFURANTOIN
Nitrofurantoin	NITROFURANTOIN	Trigen Laboratories, LLC	39ffb8c6-4dd8-4436-b857-7306c15f662a	2023-05-11	Warnings, Adverse reactions	Name fallback brand name: Nitrofurantoin generic name: NITROFURANTOIN
NITROFURANTOIN	NITROFURANTOIN	Alembic Pharmaceuticals Inc.	a8a0d7d7-1e18-46a7-a1f8-e97499820035	2023-05-05	Warnings, Adverse reactions	Name fallback brand name: NITROFURANTOIN generic name: NITROFURANTOIN
NITROFURANTOIN	NITROFURANTOIN	Alembic Pharmaceuticals Limited	152e4fe2-7665-4725-af76-b241bd816937	2023-01-30	Warnings, Adverse reactions	Name fallback brand name: NITROFURANTOIN generic name: NITROFURANTOIN
Nitrofurantoin	NITROFURANTOIN	Proficient Rx LP	34d3c103-27b8-454b-9f38-c33157c3b6fc	2022-11-01	Warnings, Adverse reactions	Name fallback brand name: Nitrofurantoin generic name: NITROFURANTOIN
Nitrofurantoin	NITROFURANTOIN	Lupin Pharmaceuticals,Inc.	93c37857-38f1-4e2e-acb8-4846840e3e85	2022-06-02	Warnings, Adverse reactions	Name fallback brand name: Nitrofurantoin generic name: NITROFURANTOIN
Nitrofurantoin	NITROFURANTOIN	Novel Laboratories, Inc.	499f9dfd-b533-4021-a3ed-308f0f956c79	2016-11-14	Warnings, Adverse reactions	Name fallback brand name: Nitrofurantoin generic name: NITROFURANTOIN

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
21695-300	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	Rebel Distributors Corp	ANDA	Current