Application 090618

Type: ANDA
Sponsor: GLENMARK GENERICS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NIZATIDINE	NIZATIDINE	CAPSULE;ORAL	150MG	No	No
002	NIZATIDINE	NIZATIDINE	CAPSULE;ORAL	300MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A090618-001	NIZATIDINE	NIZATIDINE	150MG	CAPSULE / ORAL			2011-07-15
A090618-002	NIZATIDINE	NIZATIDINE	300MG	CAPSULE / ORAL			2011-07-15

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 3 · 86 observed 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	A090618-001	NIZATIDINE	150MG	CAPSULE / ORAL		2011-07-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090618-002	NIZATIDINE	300MG	CAPSULE / ORAL		2011-07-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090618-001	NIZATIDINE	150MG	CAPSULE / ORAL		2011-07-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090618-002	NIZATIDINE	300MG	CAPSULE / ORAL		2011-07-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090618-001	NIZATIDINE	150MG	CAPSULE / ORAL		2011-07-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090618-002	NIZATIDINE	300MG	CAPSULE / ORAL		2011-07-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090618-001	NIZATIDINE	150MG	CAPSULE / ORAL		2011-07-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090618-002	NIZATIDINE	300MG	CAPSULE / ORAL		2011-07-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090618-001	NIZATIDINE	150MG	CAPSULE / ORAL		2011-07-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090618-002	NIZATIDINE	300MG	CAPSULE / ORAL		2011-07-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090618-001	NIZATIDINE	150MG	CAPSULE / ORAL	AB	2011-07-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090618-002	NIZATIDINE	300MG	CAPSULE / ORAL	AB	2011-07-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090618-001	NIZATIDINE	150MG	CAPSULE / ORAL	AB	2011-07-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090618-002	NIZATIDINE	300MG	CAPSULE / ORAL	AB	2011-07-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090618-001	NIZATIDINE	150MG	CAPSULE / ORAL	AB	2011-07-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090618-002	NIZATIDINE	300MG	CAPSULE / ORAL	AB	2011-07-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090618-001	NIZATIDINE	150MG	CAPSULE / ORAL	AB	2011-07-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090618-002	NIZATIDINE	300MG	CAPSULE / ORAL	AB	2011-07-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090618-001	NIZATIDINE	150MG	CAPSULE / ORAL	AB	2011-07-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090618-002	NIZATIDINE	300MG	CAPSULE / ORAL	AB	2011-07-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090618-001	NIZATIDINE	150MG	CAPSULE / ORAL	AB	2011-07-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090618-002	NIZATIDINE	300MG	CAPSULE / ORAL	AB	2011-07-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090618-001	NIZATIDINE	150MG	CAPSULE / ORAL	AB	2011-07-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090618-002	NIZATIDINE	300MG	CAPSULE / ORAL	AB	2011-07-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090618-001	NIZATIDINE	150MG	CAPSULE / ORAL	AB	2011-07-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090618-002	NIZATIDINE	300MG	CAPSULE / ORAL	AB	2011-07-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090618-001	NIZATIDINE	150MG	CAPSULE / ORAL	AB	2011-07-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090618-002	NIZATIDINE	300MG	CAPSULE / ORAL	AB	2011-07-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090618-001	NIZATIDINE	150MG	CAPSULE / ORAL	AB	2011-07-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090618-002	NIZATIDINE	300MG	CAPSULE / ORAL	AB	2011-07-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090618-001	NIZATIDINE	150MG	CAPSULE / ORAL	AB	2011-07-15	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090618-002	NIZATIDINE	300MG	CAPSULE / ORAL	AB	2011-07-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090618-001	NIZATIDINE	150MG	CAPSULE / ORAL	AB	2011-07-15	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090618-002	NIZATIDINE	300MG	CAPSULE / ORAL	AB	2011-07-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090618-001	NIZATIDINE	150MG	CAPSULE / ORAL	AB	2011-07-15	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090618-002	NIZATIDINE	300MG	CAPSULE / ORAL	AB	2011-07-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090618-001	NIZATIDINE	150MG	CAPSULE / ORAL	AB	2011-07-15	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090618-002	NIZATIDINE	300MG	CAPSULE / ORAL	AB	2011-07-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090618-001	NIZATIDINE	150MG	CAPSULE / ORAL	AB	2011-07-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090618-002	NIZATIDINE	300MG	CAPSULE / ORAL	AB	2011-07-15	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 74 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090618-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090618-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090618-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090618-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090618-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090618-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090618-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090618-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090618-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090618-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090618-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090618-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090618-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090618-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090618-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090618-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090618-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090618-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090618-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090618-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090618-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090618-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090618-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090618-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090618-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090618-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090618-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090618-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090618-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090618-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090618-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090618-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090618-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090618-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090618-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090618-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090618-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A090618-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090618-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A090618-002	AB	1	`8869cabd3fbd…`

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
Nizatidine	NIZATIDINE	Epic Pharma, LLC	e9957997-8b85-48a0-9bb3-b878cb223236	2025-01-02	Adverse reactions	Name fallback brand name: Nizatidine generic name: NIZATIDINE
NIZATIDINE	NIZATIDINE	Amneal Pharmaceuticals LLC	39e62997-8781-449a-e054-00144ff88e88	2024-10-23	Adverse reactions	Name fallback brand name: NIZATIDINE generic name: NIZATIDINE
Nizatidine	NIZATIDINE	Actavis Pharma, Inc.	367a1004-59c1-4474-a4f6-ce8bf5a1b043	2022-06-30	Adverse reactions	Name fallback brand name: Nizatidine generic name: NIZATIDINE
Nizatidine	NIZATIDINE	Dr Reddy's Laboratories Limited	faaa7cc4-fda9-d5b8-de2a-71c8744ccb76	2018-12-06	Adverse reactions	Name fallback brand name: Nizatidine generic name: NIZATIDINE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 13 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
45865-374	Nizatidine	Nizatidine	Medsource Pharmaceuticals	ANDA	Current
63187-249	Nizatidine	Nizatidine	Proficient Rx LP	ANDA	Current
63187-249	Nizatidine	Nizatidine	Proficient Rx LP	ANDA	Current
68071-1633	Nizatidine	Nizatidine	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-1633	Nizatidine	Nizatidine	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-1633	Nizatidine	Nizatidine	NuCare Pharmaceuticals,Inc.	ANDA	Current
68462-425	Nizatidine	Nizatidine	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-425	Nizatidine	Nizatidine	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-426	Nizatidine	Nizatidine	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-426	Nizatidine	Nizatidine	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68788-8913	Nizatidine	Nizatidine	Preferred Pharmaceuticals Inc.	ANDA	Current
71335-0086	Nizatidine	Nizatidine	Bryant Ranch Prepack	ANDA	Current
71335-0086	Nizatidine	Nizatidine	Bryant Ranch Prepack	ANDA	Current