Application 021498

Type: NDA
Sponsor: ROMARK

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ALINIA	NITAZOXANIDE	FOR SUSPENSION;ORAL	100MG/5ML	Yes	Yes

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
N021498-001	ALINIA	NITAZOXANIDE	100MG/5ML	FOR SUSPENSION / ORAL		RLD	2002-11-22

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 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021498-001	ALINIA	100MG/5ML	FOR SUSPENSION / ORAL	RLD	2002-11-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021498-001	ALINIA	100MG/5ML	FOR SUSPENSION / ORAL	RLD	2002-11-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021498-001	ALINIA	100MG/5ML	FOR SUSPENSION / ORAL	RLD	2002-11-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021498-001	ALINIA	100MG/5ML	FOR SUSPENSION / ORAL	RLD	2002-11-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021498-001	ALINIA	100MG/5ML	FOR SUSPENSION / ORAL	RLD	2002-11-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021498-001	ALINIA	100MG/5ML	FOR SUSPENSION / ORAL	RLD	2002-11-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021498-001	ALINIA	100MG/5ML	FOR SUSPENSION / ORAL	RLD	2002-11-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021498-001	ALINIA	100MG/5ML	FOR SUSPENSION / ORAL	RLD, RS	2002-11-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021498-001	ALINIA	100MG/5ML	FOR SUSPENSION / ORAL	RLD	2002-11-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021498-001	ALINIA	100MG/5ML	FOR SUSPENSION / ORAL	RLD	2002-11-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021498-001	ALINIA	100MG/5ML	FOR SUSPENSION / ORAL	RLD, RS	2002-11-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021498-001	ALINIA	100MG/5ML	FOR SUSPENSION / ORAL	RLD, RS	2002-11-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021498-001	ALINIA	100MG/5ML	FOR SUSPENSION / ORAL	RLD, RS	2002-11-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021498-001	ALINIA	100MG/5ML	FOR SUSPENSION / ORAL	RLD, RS	2002-11-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021498-001	ALINIA	100MG/5ML	FOR SUSPENSION / ORAL	RLD, RS	2002-11-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021498-001	ALINIA	100MG/5ML	FOR SUSPENSION / ORAL	RLD, RS	2002-11-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021498-001	ALINIA	100MG/5ML	FOR SUSPENSION / ORAL	RLD, RS	2002-11-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021498-001	ALINIA	100MG/5ML	FOR SUSPENSION / ORAL	RLD, RS	2002-11-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021498-001	ALINIA	100MG/5ML	FOR SUSPENSION / ORAL	RLD, RS	2002-11-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021498-001	ALINIA	100MG/5ML	FOR SUSPENSION / ORAL	RLD, RS	2002-11-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021498-001	ALINIA	100MG/5ML	FOR SUSPENSION / ORAL	RLD, RS	2002-11-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021498-001	ALINIA	100MG/5ML	FOR SUSPENSION / ORAL	RLD, RS	2002-11-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021498-001	ALINIA	100MG/5ML	FOR SUSPENSION / ORAL	RLD, RS	2002-11-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021498-001	ALINIA	100MG/5ML	FOR SUSPENSION / ORAL	RLD, RS	2002-11-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021498-001	ALINIA	100MG/5ML	FOR SUSPENSION / ORAL	RLD, RS	2002-11-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021498-001	ALINIA	100MG/5ML	FOR SUSPENSION / ORAL	RLD, RS	2002-11-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021498-001	ALINIA	100MG/5ML	FOR SUSPENSION / ORAL	RLD, RS	2002-11-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021498-001	ALINIA	100MG/5ML	FOR SUSPENSION / ORAL	RLD, RS	2002-11-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021498-001	ALINIA	100MG/5ML	FOR SUSPENSION / ORAL	RLD, RS	2002-11-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021498-001	ALINIA	100MG/5ML	FOR SUSPENSION / ORAL	RLD, RS	2002-11-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021498-001	ALINIA	100MG/5ML	FOR SUSPENSION / ORAL	RLD, RS	2002-11-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021498-001	ALINIA	100MG/5ML	FOR SUSPENSION / ORAL	RLD, RS	2002-11-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021498-001	ALINIA	100MG/5ML	FOR SUSPENSION / ORAL	RLD, RS	2002-11-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021498-001	ALINIA	100MG/5ML	FOR SUSPENSION / ORAL	RLD, RS	2002-11-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021498-001	ALINIA	100MG/5ML	FOR SUSPENSION / ORAL	RLD, RS	2002-11-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021498-001	ALINIA	100MG/5ML	FOR SUSPENSION / ORAL	RLD, RS	2002-11-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021498-001	ALINIA	100MG/5ML	FOR SUSPENSION / ORAL	RLD, RS	2002-11-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021498-001	ALINIA	100MG/5ML	FOR SUSPENSION / ORAL	RLD, RS	2002-11-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021498-001	ALINIA	100MG/5ML	FOR SUSPENSION / ORAL	RLD, RS	2002-11-22	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021498-001	ALINIA	100MG/5ML	FOR SUSPENSION / ORAL	RLD, RS	2002-11-22	`cb3db0bc1861…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nitazoxanide	NITAZOXANIDE	e5 Pharma, LLC	40a7cc30-76cd-49fe-965a-7823c4140d0f	2026-06-18	Adverse reactions	Name fallback generic name: NITAZOXANIDE
Nitazoxanide	NITAZOXANIDE	Camber Pharmaceuticals, Inc.	295011e1-f919-4e5a-b9e7-4c784f623a86	2025-12-30	Adverse reactions	Name fallback generic name: NITAZOXANIDE
Nitazoxanide	NITAZOXANIDE	Rising Pharma Holdings, Inc.	c0dc0656-3c46-43f9-adea-5285c522cef8	2025-10-09	Adverse reactions	Name fallback generic name: NITAZOXANIDE
Nitazoxanide	NITAZOXANIDE	ANI Pharmaceuticals, Inc.	cd3652fa-a183-4fb6-9a21-73fbeba6fc4b	2025-03-05	Adverse reactions	Name fallback generic name: NITAZOXANIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
67546-212	Alinia	nitazoxanide	Romark Laboratories, L.C.	NDA	Current
67546-212	Alinia	nitazoxanide	Romark Laboratories, L.C.	NDA	Current
67546-212	Alinia	nitazoxanide	Romark Laboratories, L.C.	NDA	Current
67546-212	Alinia	nitazoxanide	Romark Laboratories, L.C.	NDA	Current
67546-212	Alinia	nitazoxanide	Romark Laboratories, L.C.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
69934	SUPPL	2022-01-20
37076	SUPPL	2016-07-13
5547	SUPPL	2016-07-12
21697	SUPPL	2007-10-02
5546	SUPPL	2005-06-21
37075	SUPPL	2005-06-16
21696	SUPPL	2004-10-08
37074	SUPPL	2004-07-21
5545	SUPPL	2004-07-21
21695	ORIG	2003-04-25
27933	ORIG	2002-11-22
15602	ORIG	2002-11-22