Application 215002

Type: ANDA
Sponsor: ALVOGEN

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 43.

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
A215002-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE	75MG;25MG	CAPSULE / ORAL			2022-07-20

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A215002-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL		2022-07-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A215002-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL		2022-07-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215002-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL		2022-07-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215002-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL		2022-07-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215002-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL		2022-07-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215002-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL		2022-07-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215002-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL		2022-07-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215002-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL		2022-07-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215002-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL		2022-07-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215002-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL		2022-07-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215002-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL		2022-07-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215002-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL		2022-07-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215002-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL		2022-07-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215002-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL		2022-07-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215002-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL		2022-07-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215002-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL		2022-07-20	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215002-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL		2022-07-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215002-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL		2022-07-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215002-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL		2022-07-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215002-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL		2022-07-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215002-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL		2022-07-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215002-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL		2022-07-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215002-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL		2022-07-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A215002-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL		2022-07-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A215002-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2022-07-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A215002-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2022-07-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A215002-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2022-07-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A215002-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2022-07-20	`e64feba35796…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215002-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL		2022-07-20	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2023-01-26 05:58 UTC	2023-01	A215002-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A215002-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A215002-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A215002-001	AB	1	`e64feba35796…`

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 · 35 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
NITROFURANTOIN (monohydrate/macrocrystals)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	Jubilant Cadista Pharmaceuticals Inc.	1f7a9414-5592-f2ca-e063-6394a90a75f4	2025-06-30	Warnings, Adverse reactions	Name fallback brand name: NITROFURANTOIN (monohydrate/macrocrystals)
Nitrofurantoin (monohydrate/macrocrystals)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	Bryant Ranch Prepack	63a4b367-bf4b-4b5f-b3e9-394ba307886d	2025-04-10	Warnings, Adverse reactions	Name fallback brand name: Nitrofurantoin (monohydrate/macrocrystals)
NITROFURANTOIN (monohydrate/macrocrystals)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	NCS HealthCare of KY, LLC dba Vangard Labs	d1825b58-2c00-475d-8d9b-cc07c66383f5	2025-01-15	Warnings, Adverse reactions	Name fallback brand name: NITROFURANTOIN (monohydrate/macrocrystals)
NITROFURANTOIN (monohydrate/macrocrystals)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	Asclemed USA, Inc.	ee3f300a-d6d3-49c4-bd60-425f04d30b88	2025-01-09	Warnings, Adverse reactions	Name fallback brand name: NITROFURANTOIN (monohydrate/macrocrystals)
Nitrofurantoin (monohydrate/macrocrystals)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	NuCare Pharmaceuticals,Inc.	68a651f9-1aef-792e-e053-2991aa0a3cbb	2024-12-30	Warnings, Adverse reactions	Name fallback brand name: Nitrofurantoin (monohydrate/macrocrystals)
Nitrofurantoin (monohydrate/macrocrystals)	NITROFURANTOIN MONOHYDRATE/MACROCRYSTALS	Amneal Pharmaceuticals LLC	55c75f27-b5fc-4f19-8607-08f8ec0c69ec	2024-10-30	Warnings, Adverse reactions	Name fallback brand name: Nitrofurantoin (monohydrate/macrocrystals)
NITROFURANTOIN (monohydrate/macrocrystals)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	Jubilant Cadista Pharmaceuticals Inc.	266824c7-7e9f-4c5f-b642-3bb7bf1c4fe6	2024-08-27	Warnings, Adverse reactions	Name fallback brand name: NITROFURANTOIN (monohydrate/macrocrystals)
Nitrofurantoin (monohydrate/macrocrystals)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	Proficient Rx LP	f49f586a-79f0-4731-97f9-9aeb0839ece5	2024-08-19	Warnings, Adverse reactions	Name fallback brand name: Nitrofurantoin (monohydrate/macrocrystals)
Nitrofurantoin (monohydrate/macrocrystals)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	NuCare Pharmaceuticals,Inc.	6bccbaab-151b-4a04-e053-2991aa0ae105	2024-06-10	Warnings, Adverse reactions	Name fallback brand name: Nitrofurantoin (monohydrate/macrocrystals)
Nitrofurantoin (monohydrate/macrocrystals)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	Sandoz Inc	7ba9a729-a73a-4a13-a336-0284cc8a67e1	2024-02-28	Warnings, Adverse reactions	Name fallback brand name: Nitrofurantoin (monohydrate/macrocrystals)
Nitrofurantoin (monohydrate/macrocrystals)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	Bryant Ranch Prepack	05f4b126-0fb9-5ee9-c89c-f229e60f84e3	2023-11-09	Warnings, Adverse reactions	Name fallback brand name: Nitrofurantoin (monohydrate/macrocrystals)
Nitrofurantoin (monohydrate/macrocrystals)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	NorthStar RxLLC	d1c778b5-70df-4312-976b-d0bca0cb602a	2023-10-05	Warnings, Adverse reactions	Name fallback brand name: Nitrofurantoin (monohydrate/macrocrystals)
Nitrofurantoin (monohydrate/macrocrystals)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	Lifestar Pharma LLC	35c0a6d8-ff85-4d9b-9ad3-ae20808119dd	2023-07-14	Warnings, Adverse reactions	Name fallback brand name: Nitrofurantoin (monohydrate/macrocrystals)
Nitrofurantoin (monohydrate/macrocrystals)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	Asclemed USA, Inc.	1ab658f0-021a-46a1-bff3-d3334c23442d	2022-09-21	Warnings, Adverse reactions	Name fallback brand name: Nitrofurantoin (monohydrate/macrocrystals)
Nitrofurantoin (monohydrate/macrocrystals)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	Proficient Rx LP	d802d734-dc8f-4f3c-bce6-aaccc4614c89	2022-09-01	Warnings, Adverse reactions	Name fallback brand name: Nitrofurantoin (monohydrate/macrocrystals)

Reported adverse events (FAERS/openFDA)#

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