Application 070433

Type: ANDA
Sponsor: HIKMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FUROSEMIDE	FUROSEMIDE	SOLUTION;ORAL	40MG/5ML	No	No

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

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
A070433-001	FUROSEMIDE	FUROSEMIDE	40MG/5ML	SOLUTION / ORAL		RS	1987-04-22

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 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2022-10-28 04:53 UTC	2022-10	A070433-001	FUROSEMIDE	40MG/5ML	SOLUTION / ORAL		1987-04-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A070433-001	FUROSEMIDE	40MG/5ML	SOLUTION / ORAL		1987-04-22	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A070433-001	FUROSEMIDE	40MG/5ML	SOLUTION / ORAL		1987-04-22	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A070433-001	FUROSEMIDE	40MG/5ML	SOLUTION / ORAL	RS	1987-04-22	`a50c72e98297…`

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 1 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Furosemide	FUROSEMIDE	Atlantic Biologicals Corps	9c342198-7162-4cc5-bda1-bc4054a4292b	2026-06-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070433 application number: ANDA070433 ndc (product): 17856-3298
Furosemide	FUROSEMIDE	Hikma Pharmaceuticals USA Inc.	9e493331-dddd-496e-abf8-61747fb67aba	2025-11-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070433 application number: ANDA070433 ndc (product): 0054-3298
Furosemide	FUROSEMIDE	Precision Dose Inc.	3fd02fb5-98a0-4eda-a0ec-41faabe04706	2024-06-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070433 application number: ANDA070433 ndc (product): 68094-867

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 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0054-3298	Furosemide	Furosemide	West-Ward Pharmaceuticals Corp.	ANDA	Current
0054-3298	Furosemide	Furosemide	West-Ward Pharmaceuticals Corp.	ANDA	Current
0054-3298	Furosemide	Furosemide	West-Ward Pharmaceuticals Corp.	ANDA	Current
17856-3298	Furosemide	Furosemide	Atlantic Biologicals Corps	ANDA	Current
17856-3755	Furosemide	Furosemide	Atlantic Biologicals Corps	ANDA	Current
68094-867	Furosemide	Furosemide	Precision Dose Inc.	ANDA	Current
68094-867	Furosemide	Furosemide	Precision Dose Inc.	ANDA	Current
68094-867	Furosemide	Furosemide	Precision Dose Inc.	ANDA	Current
68094-867	Furosemide	Furosemide	Precision Dose Inc.	ANDA	Current
68094-867	Furosemide	Furosemide	Precision Dose Inc.	ANDA	Current