Application 202250

Type: ANDA
Sponsor: WATSON LABS INC

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 1.

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
A202250-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE	75MG;25MG	CAPSULE / ORAL	AB		2015-07-08

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A202250-001	AB

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	RLD / RS	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A202250-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB		2015-07-08	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A202250-001	AB	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 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)	REMEDYREPACK INC.	ae892973-9ef4-4cf0-baf3-fbe158697bac	2026-07-02	Warnings, Adverse reactions	Name fallback brand name: Nitrofurantoin (monohydrate/macrocrystals)
Nitrofurantoin (monohydrate/macrocrystals)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	BluePoint Laboratories	ea28d766-d6e6-43d2-8282-dc78a0381057	2026-06-24	Warnings, Adverse reactions	Name fallback brand name: Nitrofurantoin (monohydrate/macrocrystals)
Nitrofurantoin (monohydrate/macrocrystals)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	St. Mary's Medical Park Pharmacy	87210c87-b7db-0f65-e053-2a91aa0a4393	2026-06-07	Warnings, Adverse reactions	Name fallback brand name: Nitrofurantoin (monohydrate/macrocrystals)
Nitrofurantoin (monohydrate/macrocrystals)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	Coupler LLC	513b514f-6e79-f187-e063-6394a90a07dc	2026-05-07	Warnings, Adverse reactions	Name fallback brand name: Nitrofurantoin (monohydrate/macrocrystals)
Nitrofurantoin (monohydrate/macrocrystals)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	Coupler LLC	5087f071-5ef4-753e-e063-6294a90afb8d	2026-04-28	Warnings, Adverse reactions	Name fallback brand name: Nitrofurantoin (monohydrate/macrocrystals)
Nitrofurantoin (monohydrate/macrocrystals)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	REMEDYREPACK INC.	e55f3dc2-c754-4550-a2c0-c304471a8791	2026-04-27	Warnings, Adverse reactions	Name fallback brand name: Nitrofurantoin (monohydrate/macrocrystals)
NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	Creekwood Pharmaceuticals LLC	e47175a3-68a2-4084-9c0e-96fb057448bf	2026-04-14	Warnings, Adverse reactions	Name fallback brand name: NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)
Nitrofurantoin (monohydrate/macrocrystals)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	Major Pharmaceuticals	85c7d4ee-99f5-4324-a5fa-601c2fe664ab	2026-04-06	Warnings, Adverse reactions	Name fallback brand name: Nitrofurantoin (monohydrate/macrocrystals)
Nitrofurantoin (monohydrate/macrocrystals)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	Redpharm Drug	18987b15-6554-6b55-e063-6294a90a58d4	2026-03-11	Warnings, Adverse reactions	Name fallback brand name: Nitrofurantoin (monohydrate/macrocrystals)
NITROFURANTOIN (monohydrate/macrocrystals)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	Northwind Health Company, LLC	25172572-dbdc-db70-e063-6394a90aa87b	2026-02-04	Warnings, Adverse reactions	Name fallback brand name: NITROFURANTOIN (monohydrate/macrocrystals)
Nitrofurantoin (monohydrate/macrocrystals)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	Northwind Health Company, LLC	0631d961-ef23-8f2a-e063-6294a90aa0a8	2026-01-26	Warnings, Adverse reactions	Name fallback brand name: Nitrofurantoin (monohydrate/macrocrystals)
Nitrofurantoin (monohydrate/macrocrystals)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	Preferred Pharmaceuticals Inc.	11e8f91c-5712-4267-9956-e619d081d1f4	2026-01-16	Warnings, Adverse reactions	Name fallback brand name: Nitrofurantoin (monohydrate/macrocrystals)
Nitrofurantoin (monohydrate/macrocrystals)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	PD-Rx Pharmaceuticals, Inc.	7767697f-4dd0-477d-b5cc-e1ed5689f097	2026-01-05	Warnings, Adverse reactions	Name fallback brand name: Nitrofurantoin (monohydrate/macrocrystals)
Nitrofurantoin (monohydrate/macrocrystals)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	PD-Rx Pharmaceuticals, Inc.	643cdcff-8599-4326-b3ca-d9fd270e0fc2	2026-01-05	Warnings, Adverse reactions	Name fallback brand name: Nitrofurantoin (monohydrate/macrocrystals)
Nitrofurantoin (monohydrate/macrocrystals)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	Northwind Health Company, LLC	04b4189e-9b21-78ed-e063-6394a90ab8e0	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Nitrofurantoin (monohydrate/macrocrystals)
Nitrofurantoin (monohydrate/macrocrystals)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	QPharma, Inc.	fbc05ccb-782b-55f6-e053-6394a90a7fd6	2025-12-16	Warnings, Adverse reactions	Name fallback brand name: Nitrofurantoin (monohydrate/macrocrystals)
Nitrofurantoin (monohydrate/macrocrystals)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	NuCare Pharmaceuticals,Inc.	155c8d68-576e-f85c-e063-6294a90ada4b	2025-12-10	Warnings, Adverse reactions	Name fallback brand name: Nitrofurantoin (monohydrate/macrocrystals)
NITROFURANTOIN (monohydrate/macrocrystals)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	Redpharm Drug	3dd034a6-8810-93f5-e063-6394a90a36c2	2025-12-02	Warnings, Adverse reactions	Name fallback brand name: NITROFURANTOIN (monohydrate/macrocrystals)
NITROFURANTOIN (monohydrate/macrocrystals)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	QPharma, Inc.	055477be-e42c-fe8b-e063-6394a90a0449	2025-12-01	Warnings, Adverse reactions	Name fallback brand name: NITROFURANTOIN (monohydrate/macrocrystals)
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)