Application 075806

Type: ANDA
Sponsor: MYLAN PHARMS INC

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	Yes

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

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
A075806-001	NIZATIDINE	NIZATIDINE	150MG	CAPSULE / ORAL			2002-07-05
A075806-002	NIZATIDINE	NIZATIDINE	300MG	CAPSULE / ORAL			2002-07-05

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 3 · 88 observed 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
2019-12-13 00:20 UTC	2019-12	A075806-001	NIZATIDINE	150MG	CAPSULE / ORAL	AB		2002-07-05	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075806-002	NIZATIDINE	300MG	CAPSULE / ORAL	AB	RS	2002-07-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075806-001	NIZATIDINE	150MG	CAPSULE / ORAL			2002-07-05	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075806-002	NIZATIDINE	300MG	CAPSULE / ORAL			2002-07-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075806-001	NIZATIDINE	150MG	CAPSULE / ORAL			2002-07-05	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075806-002	NIZATIDINE	300MG	CAPSULE / ORAL			2002-07-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075806-001	NIZATIDINE	150MG	CAPSULE / ORAL			2002-07-05	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075806-002	NIZATIDINE	300MG	CAPSULE / ORAL			2002-07-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075806-001	NIZATIDINE	150MG	CAPSULE / ORAL			2002-07-05	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A075806-002	NIZATIDINE	300MG	CAPSULE / ORAL			2002-07-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075806-001	NIZATIDINE	150MG	CAPSULE / ORAL			2002-07-05	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A075806-002	NIZATIDINE	300MG	CAPSULE / ORAL			2002-07-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075806-001	NIZATIDINE	150MG	CAPSULE / ORAL			2002-07-05	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A075806-002	NIZATIDINE	300MG	CAPSULE / ORAL			2002-07-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075806-001	NIZATIDINE	150MG	CAPSULE / ORAL	AB		2002-07-05	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A075806-002	NIZATIDINE	300MG	CAPSULE / ORAL	AB	RS	2002-07-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075806-001	NIZATIDINE	150MG	CAPSULE / ORAL	AB		2002-07-05	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A075806-002	NIZATIDINE	300MG	CAPSULE / ORAL	AB	RS	2002-07-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075806-001	NIZATIDINE	150MG	CAPSULE / ORAL	AB		2002-07-05	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A075806-002	NIZATIDINE	300MG	CAPSULE / ORAL	AB	RS	2002-07-05	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075806-001	NIZATIDINE	150MG	CAPSULE / ORAL			2002-07-05	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075806-002	NIZATIDINE	300MG	CAPSULE / ORAL			2002-07-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075806-001	NIZATIDINE	150MG	CAPSULE / ORAL			2002-07-05	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A075806-002	NIZATIDINE	300MG	CAPSULE / ORAL			2002-07-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075806-001	NIZATIDINE	150MG	CAPSULE / ORAL			2002-07-05	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A075806-002	NIZATIDINE	300MG	CAPSULE / ORAL			2002-07-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075806-001	NIZATIDINE	150MG	CAPSULE / ORAL			2002-07-05	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075806-002	NIZATIDINE	300MG	CAPSULE / ORAL			2002-07-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075806-001	NIZATIDINE	150MG	CAPSULE / ORAL			2002-07-05	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075806-002	NIZATIDINE	300MG	CAPSULE / ORAL			2002-07-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075806-001	NIZATIDINE	150MG	CAPSULE / ORAL			2002-07-05	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075806-002	NIZATIDINE	300MG	CAPSULE / ORAL			2002-07-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075806-001	NIZATIDINE	150MG	CAPSULE / ORAL			2002-07-05	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075806-002	NIZATIDINE	300MG	CAPSULE / ORAL			2002-07-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075806-001	NIZATIDINE	150MG	CAPSULE / ORAL			2002-07-05	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A075806-002	NIZATIDINE	300MG	CAPSULE / ORAL			2002-07-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075806-001	NIZATIDINE	150MG	CAPSULE / ORAL			2002-07-05	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A075806-002	NIZATIDINE	300MG	CAPSULE / ORAL			2002-07-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075806-001	NIZATIDINE	150MG	CAPSULE / ORAL			2002-07-05	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075806-002	NIZATIDINE	300MG	CAPSULE / ORAL			2002-07-05	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A075806-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075806-002	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A075806-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A075806-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075806-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A075806-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075806-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A075806-002	AB	1	`ea99ee380514…`

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

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 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-5150	Nizatidine	nizatidine	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5150	Nizatidine	nizatidine	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5300	Nizatidine	nizatidine	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5300	Nizatidine	nizatidine	Mylan Pharmaceuticals Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
31022	ORIG	2004-06-10