Application 090576

Type: ANDA
Sponsor: AMNEAL PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NIZATIDINE	NIZATIDINE	SOLUTION;ORAL	15MG/ML	No	Yes

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
A090576-001	NIZATIDINE	NIZATIDINE	15MG/ML	SOLUTION / ORAL			2009-11-18

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 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A090576-001	NIZATIDINE	15MG/ML	SOLUTION / ORAL		2009-11-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090576-001	NIZATIDINE	15MG/ML	SOLUTION / ORAL		2009-11-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090576-001	NIZATIDINE	15MG/ML	SOLUTION / ORAL		2009-11-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090576-001	NIZATIDINE	15MG/ML	SOLUTION / ORAL		2009-11-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090576-001	NIZATIDINE	15MG/ML	SOLUTION / ORAL		2009-11-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090576-001	NIZATIDINE	15MG/ML	SOLUTION / ORAL		2009-11-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090576-001	NIZATIDINE	15MG/ML	SOLUTION / ORAL		2009-11-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090576-001	NIZATIDINE	15MG/ML	SOLUTION / ORAL		2009-11-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090576-001	NIZATIDINE	15MG/ML	SOLUTION / ORAL		2009-11-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090576-001	NIZATIDINE	15MG/ML	SOLUTION / ORAL		2009-11-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090576-001	NIZATIDINE	15MG/ML	SOLUTION / ORAL		2009-11-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090576-001	NIZATIDINE	15MG/ML	SOLUTION / ORAL		2009-11-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090576-001	NIZATIDINE	15MG/ML	SOLUTION / ORAL		2009-11-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090576-001	NIZATIDINE	15MG/ML	SOLUTION / ORAL		2009-11-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090576-001	NIZATIDINE	15MG/ML	SOLUTION / ORAL		2009-11-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090576-001	NIZATIDINE	15MG/ML	SOLUTION / ORAL		2009-11-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090576-001	NIZATIDINE	15MG/ML	SOLUTION / ORAL	RS	2009-11-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090576-001	NIZATIDINE	15MG/ML	SOLUTION / ORAL	RS	2009-11-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090576-001	NIZATIDINE	15MG/ML	SOLUTION / ORAL	RS	2009-11-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090576-001	NIZATIDINE	15MG/ML	SOLUTION / ORAL	RS	2009-11-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090576-001	NIZATIDINE	15MG/ML	SOLUTION / ORAL	RS	2009-11-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090576-001	NIZATIDINE	15MG/ML	SOLUTION / ORAL	RS	2009-11-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090576-001	NIZATIDINE	15MG/ML	SOLUTION / ORAL	RS	2009-11-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090576-001	NIZATIDINE	15MG/ML	SOLUTION / ORAL	RS	2009-11-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090576-001	NIZATIDINE	15MG/ML	SOLUTION / ORAL	RS	2009-11-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090576-001	NIZATIDINE	15MG/ML	SOLUTION / ORAL	RS	2009-11-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090576-001	NIZATIDINE	15MG/ML	SOLUTION / ORAL	RS	2009-11-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090576-001	NIZATIDINE	15MG/ML	SOLUTION / ORAL	RS	2009-11-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090576-001	NIZATIDINE	15MG/ML	SOLUTION / ORAL	RS	2009-11-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090576-001	NIZATIDINE	15MG/ML	SOLUTION / ORAL		2009-11-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090576-001	NIZATIDINE	15MG/ML	SOLUTION / ORAL		2009-11-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090576-001	NIZATIDINE	15MG/ML	SOLUTION / ORAL		2009-11-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090576-001	NIZATIDINE	15MG/ML	SOLUTION / ORAL		2009-11-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090576-001	NIZATIDINE	15MG/ML	SOLUTION / ORAL		2009-11-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090576-001	NIZATIDINE	15MG/ML	SOLUTION / ORAL		2009-11-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090576-001	NIZATIDINE	15MG/ML	SOLUTION / ORAL		2009-11-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090576-001	NIZATIDINE	15MG/ML	SOLUTION / ORAL		2009-11-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090576-001	NIZATIDINE	15MG/ML	SOLUTION / ORAL		2009-11-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090576-001	NIZATIDINE	15MG/ML	SOLUTION / ORAL		2009-11-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090576-001	NIZATIDINE	15MG/ML	SOLUTION / ORAL		2009-11-18	`f41ea6bd6efb…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
NIZATIDINE	NIZATIDINE	Amneal Pharmaceuticals LLC	39e62997-8781-449a-e054-00144ff88e88	2024-10-23	Adverse reactions	Exact identifier application applno (ANDA): 090576 application number: ANDA090576 ndc (product): 60846-301

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
60846-301	NIZATIDINE	NIZATIDINE	Amneal Pharmaceuticals LLC	ANDA	Current
60846-301	NIZATIDINE	NIZATIDINE	Amneal Pharmaceuticals LLC	ANDA	Current
60846-301	Nizatidine Solution	Nizatidine	Gemini Laboratories, LLC	ANDA	Current
60846-301	NIZATIDINE	NIZATIDINE	Amneal Pharmaceuticals LLC	ANDA	Current
60846-301	NIZATIDINE	NIZATIDINE	Amneal Pharmaceuticals LLC	ANDA	Current
65162-659	Nizatidine	Nizatidine	Amneal Pharmaceuticals LLC	ANDA	Current
65162-659	Nizatidine	Nizatidine	Amneal Pharmaceuticals LLC	ANDA	Current
65162-659	Nizatidine	Nizatidine	Amneal Pharmaceuticals LLC	ANDA	Current
65162-659	Nizatidine	Nizatidine	Amneal Pharmaceuticals LLC	ANDA	Current
65162-659	Nizatidine	Nizatidine	Amneal Pharmaceuticals LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
18537	ORIG	2010-08-27
9279	ORIG	2009-11-20