Application 008693

Type: NDA
Sponsor: PROCTER AND GAMBLE

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N008693-001	FURADANTIN	NITROFURANTOIN	50MG	TABLET / ORAL		Approved before 1982
N008693-002	FURADANTIN	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 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N008693-001	FURADANTIN	50MG	TABLET / ORAL	Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N008693-002	FURADANTIN	100MG	TABLET / ORAL	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N008693-001	FURADANTIN	50MG	TABLET / ORAL	Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N008693-002	FURADANTIN	100MG	TABLET / ORAL	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N008693-001	FURADANTIN	50MG	TABLET / ORAL	Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N008693-002	FURADANTIN	100MG	TABLET / ORAL	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N008693-001	FURADANTIN	50MG	TABLET / ORAL	Approved before 1982	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N008693-002	FURADANTIN	100MG	TABLET / ORAL	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N008693-001	FURADANTIN	50MG	TABLET / ORAL	Approved before 1982	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N008693-002	FURADANTIN	100MG	TABLET / ORAL	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N008693-001	FURADANTIN	50MG	TABLET / ORAL	Approved before 1982	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N008693-002	FURADANTIN	100MG	TABLET / ORAL	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N008693-001	FURADANTIN	50MG	TABLET / ORAL	Approved before 1982	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N008693-002	FURADANTIN	100MG	TABLET / ORAL	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N008693-001	FURADANTIN	50MG	TABLET / ORAL	Approved before 1982	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N008693-002	FURADANTIN	100MG	TABLET / ORAL	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N008693-001	FURADANTIN	50MG	TABLET / ORAL	Approved before 1982	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N008693-002	FURADANTIN	100MG	TABLET / ORAL	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N008693-001	FURADANTIN	50MG	TABLET / ORAL	Approved before 1982	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N008693-002	FURADANTIN	100MG	TABLET / ORAL	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N008693-001	FURADANTIN	50MG	TABLET / ORAL	Approved before 1982	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N008693-002	FURADANTIN	100MG	TABLET / ORAL	Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N008693-001	FURADANTIN	50MG	TABLET / ORAL	Approved before 1982	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N008693-002	FURADANTIN	100MG	TABLET / ORAL	Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N008693-001	FURADANTIN	50MG	TABLET / ORAL	Approved before 1982	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N008693-002	FURADANTIN	100MG	TABLET / ORAL	Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N008693-001	FURADANTIN	50MG	TABLET / ORAL	Approved before 1982	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N008693-002	FURADANTIN	100MG	TABLET / ORAL	Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N008693-001	FURADANTIN	50MG	TABLET / ORAL	Approved before 1982	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N008693-002	FURADANTIN	100MG	TABLET / ORAL	Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N008693-001	FURADANTIN	50MG	TABLET / ORAL	Approved before 1982	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N008693-002	FURADANTIN	100MG	TABLET / ORAL	Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N008693-001	FURADANTIN	50MG	TABLET / ORAL	Approved before 1982	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N008693-002	FURADANTIN	100MG	TABLET / ORAL	Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N008693-001	FURADANTIN	50MG	TABLET / ORAL	Approved before 1982	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N008693-002	FURADANTIN	100MG	TABLET / ORAL	Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N008693-001	FURADANTIN	50MG	TABLET / ORAL	Approved before 1982	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N008693-002	FURADANTIN	100MG	TABLET / ORAL	Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N008693-001	FURADANTIN	50MG	TABLET / ORAL	Approved before 1982	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N008693-002	FURADANTIN	100MG	TABLET / ORAL	Approved before 1982	`3a93d1ddd44b…`

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 2 · 31 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
NITROFURANTOIN	NITROFURANTOIN	REMEDYREPACK INC.	87505f8f-2056-4e55-adf5-5b7309081d7c	2026-09-01	Warnings, Adverse reactions	Name fallback generic name: NITROFURANTOIN
Nitrofurantoin	NITROFURANTOIN	REMEDYREPACK INC.	6c82b95d-2c32-4e54-a8a9-a4bb4df70cb5	2026-08-19	Warnings, Adverse reactions	Name fallback generic name: NITROFURANTOIN
Nitrofurantoin	NITROFURANTOIN	Preferred Pharmaceuticals Inc.	729f6bbb-ab64-4b65-979a-4ad7605c5947	2026-08-04	Warnings, Adverse reactions	Name fallback generic name: NITROFURANTOIN
Nitrofurantoin	NITROFURANTOIN	St. Mary's Medical Park Pharmacy	09944470-807d-ad37-e063-6394a90a7bfe	2026-06-23	Warnings, Adverse reactions	Name fallback generic name: NITROFURANTOIN
Nitrofurantoin	NITROFURANTOIN	Somerset Therapeutics, LLC	dd99ba40-edff-47c3-9ee4-7e5b7774e5b5	2026-01-22	Warnings, Adverse reactions	Name fallback generic name: NITROFURANTOIN
Nitrofurantoin	NITROFURANTOIN	Rising Pharma Holdings, Inc.	89095f4d-e142-465e-b378-da24f6eeaf2b	2025-11-11	Warnings, Adverse reactions	Name fallback generic name: NITROFURANTOIN
Nitrofurantoin	NITROFURANTOIN	Bryant Ranch Prepack	1c5db054-58af-4932-8fad-c3883b13f987	2025-10-22	Warnings, Adverse reactions	Name fallback generic name: NITROFURANTOIN
Nitrofurantoin	NITROFURANTOIN	PD-Rx Pharmaceuticals, Inc.	d88348a0-6ab4-4490-9325-1f14a541b0a5	2025-10-14	Warnings, Adverse reactions	Name fallback generic name: NITROFURANTOIN
Nitrofurantoin	NITROFURANTOIN	PD-Rx Pharmaceuticals, Inc.	37606c6f-0d85-4314-94ae-f7732c7bc8d5	2025-10-09	Warnings, Adverse reactions	Name fallback generic name: NITROFURANTOIN
NITROFURANTOIN	NITROFURANTOIN	Proficient Rx LP	0819be0b-03e9-426e-a4b9-624c32958f94	2025-09-01	Warnings, Adverse reactions	Name fallback generic name: NITROFURANTOIN
NITROFURANTOIN	NITROFURANTOIN	Camber Pharmaceuticals, Inc.	4e06b31e-cc49-4526-beb6-e77021823aa9	2025-08-13	Warnings, Adverse reactions	Name fallback generic name: NITROFURANTOIN
Nitrofurantoin	NITROFURANTOIN	Micro Labs Limited	d96098d0-3c2b-4e53-a3f0-3ebba81c4133	2025-05-14	Warnings, Adverse reactions	Name fallback generic name: NITROFURANTOIN
Nitrofurantoin	NITROFURANTOIN	Redpharm Drug, Inc.	f4c2c01d-bef7-3e5d-e053-2995a90ae0d8	2025-01-23	Warnings, Adverse reactions	Name fallback generic name: NITROFURANTOIN
NITROFURANTOIN	NITROFURANTOIN	Directrx	d4385368-46d6-8397-e053-2a95a90a8d68	2025-01-17	Warnings, Adverse reactions	Name fallback generic name: NITROFURANTOIN
NITROFURANTOIN	NITROFURANTOIN	Biocon Pharma Inc	68c718a7-2e8f-288c-37d2-053372ee61b9	2024-11-14	Warnings, Adverse reactions	Name fallback generic name: NITROFURANTOIN
Nitrofurantoin	NITROFURANTOIN	Amneal Pharmaceuticals LLC	11dcea9c-0c62-4153-976b-bd1f8ef1f6d9	2024-10-30	Warnings, Adverse reactions	Name fallback generic name: NITROFURANTOIN
Nitrofurantoin	NITROFURANTOIN	ANI Pharmaceuticals, Inc.	3b377aff-2d4b-43ea-84c9-8e72c1421b7b	2024-10-08	Warnings, Adverse reactions	Name fallback generic name: NITROFURANTOIN
Nitrofurantoin	NITROFURANTOIN	Bryant Ranch Prepack	56e07ad3-7224-4aaf-9a68-0d48d4abfec8	2024-08-28	Warnings, Adverse reactions	Name fallback generic name: NITROFURANTOIN
Nitrofurantoin	NITROFURANTOIN	Rising Pharma Holdings, Inc.	11e700aa-66f9-4939-8a6b-a23240ae1a0b	2024-05-16	Warnings, Adverse reactions	Name fallback generic name: NITROFURANTOIN
Nitrofurantoin	NITROFURANTOIN	NorthStar Rx LLC	04af8b73-7e15-7da8-e063-6294a90af284	2024-03-29	Warnings, Adverse reactions	Name fallback generic name: NITROFURANTOIN

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
20014	SUPPL	2006-05-10