Application 203808

Type: ANDA
Sponsor: EDENBRIDGE PHARMS

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
A203808-001	TINIDAZOLE	TINIDAZOLE	250MG	TABLET / ORAL	AB		2015-08-04
A203808-002	TINIDAZOLE	TINIDAZOLE	500MG	TABLET / ORAL	AB		2015-08-04

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A203808-001	AB
A203808-002	AB

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	A203808-001	TINIDAZOLE	250MG	TABLET / ORAL	AB	2015-08-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203808-002	TINIDAZOLE	500MG	TABLET / ORAL	AB	2015-08-04	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203808-001	TINIDAZOLE	250MG	TABLET / ORAL	AB	2015-08-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203808-002	TINIDAZOLE	500MG	TABLET / ORAL	AB	2015-08-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203808-001	TINIDAZOLE	250MG	TABLET / ORAL	AB	2015-08-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203808-002	TINIDAZOLE	500MG	TABLET / ORAL	AB	2015-08-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203808-001	TINIDAZOLE	250MG	TABLET / ORAL	AB	2015-08-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203808-002	TINIDAZOLE	500MG	TABLET / ORAL	AB	2015-08-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203808-001	TINIDAZOLE	250MG	TABLET / ORAL	AB	2015-08-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203808-002	TINIDAZOLE	500MG	TABLET / ORAL	AB	2015-08-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203808-001	TINIDAZOLE	250MG	TABLET / ORAL	AB	2015-08-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203808-002	TINIDAZOLE	500MG	TABLET / ORAL	AB	2015-08-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203808-001	TINIDAZOLE	250MG	TABLET / ORAL	AB	2015-08-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203808-002	TINIDAZOLE	500MG	TABLET / ORAL	AB	2015-08-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203808-001	TINIDAZOLE	250MG	TABLET / ORAL	AB	2015-08-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203808-002	TINIDAZOLE	500MG	TABLET / ORAL	AB	2015-08-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203808-001	TINIDAZOLE	250MG	TABLET / ORAL	AB	2015-08-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203808-002	TINIDAZOLE	500MG	TABLET / ORAL	AB	2015-08-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203808-001	TINIDAZOLE	250MG	TABLET / ORAL	AB	2015-08-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203808-002	TINIDAZOLE	500MG	TABLET / ORAL	AB	2015-08-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203808-001	TINIDAZOLE	250MG	TABLET / ORAL	AB	2015-08-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203808-002	TINIDAZOLE	500MG	TABLET / ORAL	AB	2015-08-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203808-001	TINIDAZOLE	250MG	TABLET / ORAL	AB	2015-08-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203808-002	TINIDAZOLE	500MG	TABLET / ORAL	AB	2015-08-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203808-001	TINIDAZOLE	250MG	TABLET / ORAL	AB	2015-08-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203808-002	TINIDAZOLE	500MG	TABLET / ORAL	AB	2015-08-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203808-001	TINIDAZOLE	250MG	TABLET / ORAL	AB	2015-08-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203808-002	TINIDAZOLE	500MG	TABLET / ORAL	AB	2015-08-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203808-001	TINIDAZOLE	250MG	TABLET / ORAL	AB	2015-08-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203808-002	TINIDAZOLE	500MG	TABLET / ORAL	AB	2015-08-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203808-001	TINIDAZOLE	250MG	TABLET / ORAL	AB	2015-08-04	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203808-002	TINIDAZOLE	500MG	TABLET / ORAL	AB	2015-08-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203808-001	TINIDAZOLE	250MG	TABLET / ORAL	AB	2015-08-04	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203808-002	TINIDAZOLE	500MG	TABLET / ORAL	AB	2015-08-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203808-001	TINIDAZOLE	250MG	TABLET / ORAL	AB	2015-08-04	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203808-002	TINIDAZOLE	500MG	TABLET / ORAL	AB	2015-08-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203808-001	TINIDAZOLE	250MG	TABLET / ORAL	AB	2015-08-04	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203808-002	TINIDAZOLE	500MG	TABLET / ORAL	AB	2015-08-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203808-001	TINIDAZOLE	250MG	TABLET / ORAL	AB	2015-08-04	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203808-002	TINIDAZOLE	500MG	TABLET / ORAL	AB	2015-08-04	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A203808-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203808-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203808-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203808-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203808-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203808-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203808-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203808-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203808-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203808-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203808-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203808-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203808-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203808-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203808-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203808-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203808-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203808-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203808-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203808-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203808-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203808-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203808-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203808-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203808-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203808-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203808-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203808-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203808-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203808-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203808-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203808-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203808-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203808-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203808-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203808-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203808-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203808-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203808-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203808-002	AB	1	`74a2ff9319b5…`

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 · 2 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	Exact identifier application applno (ANDA): 203808 application number: ANDA203808
Tinidazole	TINIDAZOLE	Edenbridge Pharmaceuticals LLC.	6f3ce597-64c1-4204-a67a-8b6f6e7e8bca	2025-12-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203808 application number: ANDA203808 ndc (product): 42799-208 ndc (product): 42799-207

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
42799-207	Tinidazole	Tinidazole	Edenbridge Pharmaceuticals, LLC	ANDA	Current
42799-207	Tinidazole	Tinidazole	Edenbridge Pharmaceuticals LLC.	ANDA	Current
42799-207	Tinidazole	Tinidazole	Edenbridge Pharmaceuticals LLC.	ANDA	Current
42799-207	Tinidazole	Tinidazole	Edenbridge Pharmaceuticals LLC.	ANDA	Current
42799-208	Tinidazole	Tinidazole	Edenbridge Pharmaceuticals, LLC	ANDA	Current
42799-208	Tinidazole	Tinidazole	Edenbridge Pharmaceuticals LLC.	ANDA	Current
42799-208	Tinidazole	Tinidazole	Edenbridge Pharmaceuticals LLC.	ANDA	Current
42799-208	Tinidazole	Tinidazole	Edenbridge Pharmaceuticals LLC.	ANDA	Current
53002-1611	Tinidazole	Tinidazole	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-1611	Tinidazole	Tinidazole	RPK Pharmaceuticals, Inc.	ANDA	Current