Application 091095

Type: ANDA
Sponsor: ACTAVIS LABS FL INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NITROFURANTOIN	NITROFURANTOIN, MACROCRYSTALLINE	CAPSULE;ORAL	25MG	No	No
002	NITROFURANTOIN	NITROFURANTOIN, MACROCRYSTALLINE	CAPSULE;ORAL	50MG	No	No
003	NITROFURANTOIN	NITROFURANTOIN, MACROCRYSTALLINE	CAPSULE;ORAL	100MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A091095-001	NITROFURANTOIN	NITROFURANTOIN, MACROCRYSTALLINE	25MG	CAPSULE / ORAL	2015-06-18
A091095-002	NITROFURANTOIN	NITROFURANTOIN, MACROCRYSTALLINE	50MG	CAPSULE / ORAL	2015-06-18
A091095-003	NITROFURANTOIN	NITROFURANTOIN, MACROCRYSTALLINE	100MG	CAPSULE / ORAL	2015-06-18

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 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A091095-001	NITROFURANTOIN	25MG	CAPSULE / ORAL	2015-06-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091095-002	NITROFURANTOIN	50MG	CAPSULE / ORAL	2015-06-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091095-003	NITROFURANTOIN	100MG	CAPSULE / ORAL	2015-06-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091095-001	NITROFURANTOIN	25MG	CAPSULE / ORAL	2015-06-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091095-002	NITROFURANTOIN	50MG	CAPSULE / ORAL	2015-06-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091095-003	NITROFURANTOIN	100MG	CAPSULE / ORAL	2015-06-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091095-001	NITROFURANTOIN	25MG	CAPSULE / ORAL	2015-06-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091095-002	NITROFURANTOIN	50MG	CAPSULE / ORAL	2015-06-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091095-003	NITROFURANTOIN	100MG	CAPSULE / ORAL	2015-06-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091095-001	NITROFURANTOIN	25MG	CAPSULE / ORAL	2015-06-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091095-002	NITROFURANTOIN	50MG	CAPSULE / ORAL	2015-06-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091095-003	NITROFURANTOIN	100MG	CAPSULE / ORAL	2015-06-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091095-001	NITROFURANTOIN	25MG	CAPSULE / ORAL	2015-06-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091095-002	NITROFURANTOIN	50MG	CAPSULE / ORAL	2015-06-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091095-003	NITROFURANTOIN	100MG	CAPSULE / ORAL	2015-06-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091095-001	NITROFURANTOIN	25MG	CAPSULE / ORAL	2015-06-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091095-002	NITROFURANTOIN	50MG	CAPSULE / ORAL	2015-06-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091095-003	NITROFURANTOIN	100MG	CAPSULE / ORAL	2015-06-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091095-001	NITROFURANTOIN	25MG	CAPSULE / ORAL	2015-06-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091095-002	NITROFURANTOIN	50MG	CAPSULE / ORAL	2015-06-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091095-003	NITROFURANTOIN	100MG	CAPSULE / ORAL	2015-06-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091095-001	NITROFURANTOIN	25MG	CAPSULE / ORAL	2015-06-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091095-002	NITROFURANTOIN	50MG	CAPSULE / ORAL	2015-06-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091095-003	NITROFURANTOIN	100MG	CAPSULE / ORAL	2015-06-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091095-001	NITROFURANTOIN	25MG	CAPSULE / ORAL	2015-06-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091095-002	NITROFURANTOIN	50MG	CAPSULE / ORAL	2015-06-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091095-003	NITROFURANTOIN	100MG	CAPSULE / ORAL	2015-06-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091095-001	NITROFURANTOIN	25MG	CAPSULE / ORAL	2015-06-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091095-002	NITROFURANTOIN	50MG	CAPSULE / ORAL	2015-06-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091095-003	NITROFURANTOIN	100MG	CAPSULE / ORAL	2015-06-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091095-001	NITROFURANTOIN	25MG	CAPSULE / ORAL	2015-06-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091095-002	NITROFURANTOIN	50MG	CAPSULE / ORAL	2015-06-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091095-003	NITROFURANTOIN	100MG	CAPSULE / ORAL	2015-06-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091095-001	NITROFURANTOIN	25MG	CAPSULE / ORAL	2015-06-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091095-002	NITROFURANTOIN	50MG	CAPSULE / ORAL	2015-06-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091095-003	NITROFURANTOIN	100MG	CAPSULE / ORAL	2015-06-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091095-001	NITROFURANTOIN	25MG	CAPSULE / ORAL	2015-06-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091095-002	NITROFURANTOIN	50MG	CAPSULE / ORAL	2015-06-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091095-003	NITROFURANTOIN	100MG	CAPSULE / ORAL	2015-06-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091095-001	NITROFURANTOIN	25MG	CAPSULE / ORAL	2015-06-18	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 75 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091095-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091095-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091095-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091095-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091095-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091095-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091095-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091095-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091095-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091095-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091095-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091095-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091095-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091095-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091095-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091095-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091095-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091095-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091095-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091095-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091095-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091095-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A091095-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A091095-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091095-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A091095-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A091095-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091095-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A091095-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A091095-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091095-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A091095-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A091095-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091095-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A091095-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A091095-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091095-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A091095-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A091095-003	AB	1	`ea99ee380514…`
2024-02-18 07:12 UTC	2024-02	A091095-001	AB	1	`1c564ffb4f44…`

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 3 · 41 matching rows.

Brand, Generic, Manufacturer table
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	Name fallback brand name: Nitrofurantoin
Nitrofurantoin	NITROFURANTOIN	Preferred Pharmaceuticals Inc.	729f6bbb-ab64-4b65-979a-4ad7605c5947	2026-08-04	Warnings, Adverse reactions	Name fallback brand name: Nitrofurantoin
Nitrofurantoin	NITROFURANTOIN	St. Mary's Medical Park Pharmacy	09944470-807d-ad37-e063-6394a90a7bfe	2026-06-23	Warnings, Adverse reactions	Name fallback brand name: Nitrofurantoin
NITROFURANTOIN	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	A-S Medication Solutions	b6c5bbb0-86db-4a76-a1eb-98573a0b0adc	2026-06-10	Warnings, Adverse reactions	Name fallback brand name: NITROFURANTOIN
NITROFURANTOIN	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	Bryant Ranch Prepack	8450fee6-7b9d-4c74-848e-c4f42c1963f9	2026-04-20	Warnings, Adverse reactions	Name fallback brand name: NITROFURANTOIN
Nitrofurantoin	NITROFURANTOIN	REMEDYREPACK INC.	6c82b95d-2c32-4e54-a8a9-a4bb4df70cb5	2026-04-15	Warnings, Adverse reactions	Name fallback brand name: Nitrofurantoin
Nitrofurantoin	NITROFURANTOIN	Somerset Therapeutics, LLC	dd99ba40-edff-47c3-9ee4-7e5b7774e5b5	2026-01-22	Warnings, Adverse reactions	Name fallback brand name: Nitrofurantoin
NITROFURANTOIN	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	A-S Medication Solutions	2a772eb3-4fb3-4d92-b9f4-469dd2216361	2026-01-06	Warnings, Adverse reactions	Name fallback brand name: NITROFURANTOIN
Nitrofurantoin	NITROFURANTOIN	Rising Pharma Holdings, Inc.	89095f4d-e142-465e-b378-da24f6eeaf2b	2025-11-11	Warnings, Adverse reactions	Name fallback brand name: Nitrofurantoin
Nitrofurantoin	NITROFURANTOIN	Bryant Ranch Prepack	1c5db054-58af-4932-8fad-c3883b13f987	2025-10-22	Warnings, Adverse reactions	Name fallback brand name: Nitrofurantoin
Nitrofurantoin	NITROFURANTOIN	PD-Rx Pharmaceuticals, Inc.	d88348a0-6ab4-4490-9325-1f14a541b0a5	2025-10-14	Warnings, Adverse reactions	Name fallback brand name: Nitrofurantoin
Nitrofurantoin	NITROFURANTOIN	PD-Rx Pharmaceuticals, Inc.	37606c6f-0d85-4314-94ae-f7732c7bc8d5	2025-10-09	Warnings, Adverse reactions	Name fallback brand name: Nitrofurantoin
NITROFURANTOIN	NITROFURANTOIN	REMEDYREPACK INC.	87505f8f-2056-4e55-adf5-5b7309081d7c	2025-09-30	Warnings, Adverse reactions	Name fallback brand name: NITROFURANTOIN
NITROFURANTOIN	NITROFURANTOIN	Proficient Rx LP	0819be0b-03e9-426e-a4b9-624c32958f94	2025-09-01	Warnings, Adverse reactions	Name fallback brand name: NITROFURANTOIN
NITROFURANTOIN	NITROFURANTOIN	Camber Pharmaceuticals, Inc.	4e06b31e-cc49-4526-beb6-e77021823aa9	2025-08-13	Warnings, Adverse reactions	Name fallback brand name: NITROFURANTOIN
Nitrofurantoin	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	A-S Medication Solutions	b644426c-c8ba-4fe0-80c7-d9b2dde37395	2025-08-13	Warnings, Adverse reactions	Name fallback brand name: Nitrofurantoin
Nitrofurantoin	NITROFURANTOIN	Micro Labs Limited	d96098d0-3c2b-4e53-a3f0-3ebba81c4133	2025-05-14	Warnings, Adverse reactions	Name fallback brand name: Nitrofurantoin
Nitrofurantoin	NITROFURANTOIN	Redpharm Drug, Inc.	f4c2c01d-bef7-3e5d-e053-2995a90ae0d8	2025-01-23	Warnings, Adverse reactions	Name fallback brand name: Nitrofurantoin
NITROFURANTOIN	NITROFURANTOIN	Directrx	d4385368-46d6-8397-e053-2a95a90a8d68	2025-01-17	Warnings, Adverse reactions	Name fallback brand name: NITROFURANTOIN
NITROFURANTOIN	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	Aurobindo Pharma Limited	788f1fe3-d8a1-42cc-9280-07f842da34ea	2024-12-18	Warnings, Adverse reactions	Name fallback brand name: NITROFURANTOIN

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 20 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0115-2023	Nitrofurantoin	Nitrofurantoin	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-2024	Nitrofurantoin	Nitrofurantoin	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0591-3684	Nitrofurantoin	Nitrofurantoin	Actavis Pharma, Inc.	ANDA	Current
0591-3684	Nitrofurantoin	Nitrofurantoin	Actavis Pharma, Inc.	ANDA	Current
0591-3685	Nitrofurantoin	Nitrofurantoin	Actavis Pharma, Inc.	ANDA	Current
0591-3685	Nitrofurantoin	Nitrofurantoin	Actavis Pharma, Inc.	ANDA	Current
0591-3686	Nitrofurantoin	Nitrofurantoin	Actavis Pharma, Inc.	ANDA	Current
0591-3686	Nitrofurantoin	Nitrofurantoin	Actavis Pharma, Inc.	ANDA	Current
68071-2281	Nitrofurantoin	Nitrofurantoin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2281	Nitrofurantoin	Nitrofurantoin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5050	Nitrofurantoin	Nitrofurantoin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5050	Nitrofurantoin	Nitrofurantoin	NuCare Pharmaceuticals,Inc.	ANDA	Current
71205-365	Nitrofurantoin	Nitrofurantoin	Proficient Rx LP	ANDA	Current
71205-370	Nitrofurantoin	Nitrofurantoin	Proficient Rx LP	ANDA	Current
71205-370	Nitrofurantoin	Nitrofurantoin	Proficient Rx LP	ANDA	Current
71205-370	Nitrofurantoin	Nitrofurantoin	Proficient Rx LP	ANDA	Current
71335-0878	Nitrofurantoin	Nitrofurantoin	Bryant Ranch Prepack	ANDA	Current
71335-0878	Nitrofurantoin	Nitrofurantoin	Bryant Ranch Prepack	ANDA	Current
71335-0878	Nitrofurantoin	Nitrofurantoin	Bryant Ranch Prepack	ANDA	Current
71335-1374	Nitrofurantoin	Nitrofurantoin	Bryant Ranch Prepack	ANDA	Current