Application 201172

Type: ANDA
Sponsor: HIKMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TINIDAZOLE	TINIDAZOLE	TABLET;ORAL	250MG	No	No
002	TINIDAZOLE	TINIDAZOLE	TABLET;ORAL	500MG	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
A201172-001	TINIDAZOLE	TINIDAZOLE	250MG	TABLET / ORAL			2012-04-30
A201172-002	TINIDAZOLE	TINIDAZOLE	500MG	TABLET / ORAL			2012-04-30

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	A201172-001	TINIDAZOLE	250MG	TABLET / ORAL		2012-04-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201172-002	TINIDAZOLE	500MG	TABLET / ORAL		2012-04-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A201172-001	TINIDAZOLE	250MG	TABLET / ORAL		2012-04-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201172-002	TINIDAZOLE	500MG	TABLET / ORAL		2012-04-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201172-001	TINIDAZOLE	250MG	TABLET / ORAL		2012-04-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201172-002	TINIDAZOLE	500MG	TABLET / ORAL		2012-04-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201172-001	TINIDAZOLE	250MG	TABLET / ORAL		2012-04-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201172-002	TINIDAZOLE	500MG	TABLET / ORAL		2012-04-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201172-001	TINIDAZOLE	250MG	TABLET / ORAL		2012-04-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201172-002	TINIDAZOLE	500MG	TABLET / ORAL		2012-04-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201172-001	TINIDAZOLE	250MG	TABLET / ORAL		2012-04-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201172-002	TINIDAZOLE	500MG	TABLET / ORAL		2012-04-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201172-001	TINIDAZOLE	250MG	TABLET / ORAL		2012-04-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201172-002	TINIDAZOLE	500MG	TABLET / ORAL		2012-04-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201172-001	TINIDAZOLE	250MG	TABLET / ORAL		2012-04-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201172-002	TINIDAZOLE	500MG	TABLET / ORAL		2012-04-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201172-001	TINIDAZOLE	250MG	TABLET / ORAL		2012-04-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201172-002	TINIDAZOLE	500MG	TABLET / ORAL		2012-04-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201172-001	TINIDAZOLE	250MG	TABLET / ORAL		2012-04-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201172-002	TINIDAZOLE	500MG	TABLET / ORAL		2012-04-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201172-001	TINIDAZOLE	250MG	TABLET / ORAL		2012-04-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201172-002	TINIDAZOLE	500MG	TABLET / ORAL		2012-04-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201172-001	TINIDAZOLE	250MG	TABLET / ORAL		2012-04-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201172-002	TINIDAZOLE	500MG	TABLET / ORAL		2012-04-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201172-001	TINIDAZOLE	250MG	TABLET / ORAL		2012-04-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201172-002	TINIDAZOLE	500MG	TABLET / ORAL		2012-04-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201172-001	TINIDAZOLE	250MG	TABLET / ORAL		2012-04-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201172-002	TINIDAZOLE	500MG	TABLET / ORAL		2012-04-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201172-001	TINIDAZOLE	250MG	TABLET / ORAL		2012-04-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201172-002	TINIDAZOLE	500MG	TABLET / ORAL		2012-04-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201172-001	TINIDAZOLE	250MG	TABLET / ORAL		2012-04-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A201172-002	TINIDAZOLE	500MG	TABLET / ORAL		2012-04-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201172-001	TINIDAZOLE	250MG	TABLET / ORAL	AB	2012-04-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201172-002	TINIDAZOLE	500MG	TABLET / ORAL	AB	2012-04-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201172-001	TINIDAZOLE	250MG	TABLET / ORAL	AB	2012-04-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A201172-002	TINIDAZOLE	500MG	TABLET / ORAL	AB	2012-04-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201172-001	TINIDAZOLE	250MG	TABLET / ORAL	AB	2012-04-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A201172-002	TINIDAZOLE	500MG	TABLET / ORAL	AB	2012-04-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201172-001	TINIDAZOLE	250MG	TABLET / ORAL	AB	2012-04-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201172-002	TINIDAZOLE	500MG	TABLET / ORAL	AB	2012-04-30	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201172-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201172-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201172-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A201172-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201172-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A201172-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201172-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201172-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201172-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A201172-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201172-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A201172-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201172-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201172-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201172-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A201172-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201172-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A201172-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201172-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A201172-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201172-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A201172-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201172-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A201172-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201172-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A201172-002	AB	1	`ea99ee380514…`
2022-09-29 23:25 UTC	2022-09	A201172-001	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A201172-002	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A201172-001	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A201172-002	AB	1	`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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tinidazole	TINIDAZOLE	REMEDYREPACK INC.	7f552a9b-3190-4301-8352-36451a73b956	2026-08-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Tinidazole generic name: TINIDAZOLE
Tindazole	TINIDAZOLE	REMEDYREPACK INC.	45fa3ebd-52da-4987-82a1-4a64f99785a7	2026-08-18	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TINIDAZOLE
Tinidazole	TINIDAZOLE	Edenbridge Pharmaceuticals LLC.	6f3ce597-64c1-4204-a67a-8b6f6e7e8bca	2025-12-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Tinidazole generic name: TINIDAZOLE
Tinidazole	TINIDAZOLE	BioComp Pharma, Inc.	f55bcc41-2e8d-4ee5-9993-05c7d86f2d2c	2025-12-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Tinidazole generic name: TINIDAZOLE
Tindazole	TINIDAZOLE	Rising Pharma Holdings, Inc.	32167dd7-5d37-457b-9b00-cd735de6b060	2025-03-31	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TINIDAZOLE
Tinidazole	TINIDAZOLE	Chartwell RX, LLC	b39bc167-f1c4-4169-8b46-e6c2eafe6bbf	2024-07-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Tinidazole generic name: TINIDAZOLE
Tinidazole	TINIDAZOLE	Lupin Pharmaceuticals,Inc.	95ab57b2-5d7e-4986-abcd-65edf1728383	2022-02-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Tinidazole generic name: TINIDAZOLE
Tindamax	TINIDAZOLE	Mission Pharmacal Company	a0d01539-8413-4703-94cc-d221918630a1	2021-12-27	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TINIDAZOLE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0054-0347	Tinidazole	Tinidazole	West-Ward Pharmaceuticals Corp.	ANDA	Current
0054-0347	Tinidazole	Tinidazole	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0347	Tinidazole	Tinidazole	West-Ward Pharmaceuticals Corp.	ANDA	Current
0054-0347	Tinidazole	Tinidazole	West-Ward Pharmaceuticals Corp.	ANDA	Current
0054-0347	Tinidazole	Tinidazole	West-Ward Pharmaceuticals Corp.	ANDA	Current
0054-0348	Tinidazole	Tinidazole	West-Ward Pharmaceuticals Corp.	ANDA	Current
0054-0348	Tinidazole	Tinidazole	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0348	Tinidazole	Tinidazole	West-Ward Pharmaceuticals Corp.	ANDA	Current
0054-0348	Tinidazole	Tinidazole	West-Ward Pharmaceuticals Corp.	ANDA	Current
0054-0348	Tinidazole	Tinidazole	West-Ward Pharmaceuticals Corp.	ANDA	Current
67296-1729	Tinidazole	Tinidazole	RedPharm Drug, Inc.	ANDA	Current
67296-1729	Tinidazole	Tinidazole	RedPharm Drug, Inc.	ANDA	Current