Application 205245

Type: ANDA
Sponsor: HERITAGE PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	METRONIDAZOLE	METRONIDAZOLE	TABLET;ORAL	250MG	No	No
002	METRONIDAZOLE	METRONIDAZOLE	TABLET;ORAL	500MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A205245-001	METRONIDAZOLE	METRONIDAZOLE	250MG	TABLET / ORAL	AB		2015-09-23
A205245-002	METRONIDAZOLE	METRONIDAZOLE	500MG	TABLET / ORAL	AB		2015-09-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205245-001	AB
A205245-002	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 · 82 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
2026-02-19 14:30 UTC	2026-02	A205245-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2015-09-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205245-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2015-09-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205245-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2015-09-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205245-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2015-09-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205245-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2015-09-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205245-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2015-09-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205245-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2015-09-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205245-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2015-09-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205245-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2015-09-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205245-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2015-09-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205245-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2015-09-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205245-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2015-09-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205245-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2015-09-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205245-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2015-09-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205245-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2015-09-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205245-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2015-09-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205245-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2015-09-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205245-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2015-09-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205245-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2015-09-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205245-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2015-09-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205245-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2015-09-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205245-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2015-09-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205245-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2015-09-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205245-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2015-09-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205245-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2015-09-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205245-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2015-09-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205245-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2015-09-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A205245-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2015-09-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205245-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2015-09-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205245-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2015-09-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205245-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2015-09-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205245-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2015-09-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205245-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2015-09-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205245-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2015-09-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205245-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2015-09-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205245-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2015-09-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205245-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2015-09-23	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A205245-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2015-09-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205245-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2015-09-23	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A205245-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2015-09-23	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A205245-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205245-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205245-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205245-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205245-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205245-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205245-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205245-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205245-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205245-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205245-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205245-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205245-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205245-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205245-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205245-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205245-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205245-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205245-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205245-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205245-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205245-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205245-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205245-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205245-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205245-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205245-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A205245-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205245-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205245-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205245-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205245-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205245-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205245-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205245-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205245-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205245-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A205245-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205245-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A205245-002	AB	1	`782e0a99824c…`

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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Metronidazole	METRONIDAZOLE	REMEDYREPACK INC.	5cc3fd98-d579-432e-a4b5-b6d5586991a6	2026-08-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205245 application number: ANDA205245 ndc (product): 70518-3265
Metronidazole	METRONIDAZOLE	Cardinal Health 107, LLC	4e1ac737-c353-4764-bd35-dc844e75b562	2026-06-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205245 application number: ANDA205245
Metronidazole	METRONIDAZOLE	Northwind Health Company, LLC	f2f55405-7f21-3ccc-e053-2a95a90a195a	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205245 application number: ANDA205245
Metronidazole	METRONIDAZOLE	Northwind Health Company, LLC	f7e5dacd-0bc4-4ac4-e053-6394a90a457a	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205245 application number: ANDA205245
Metronidazole	METRONIDAZOLE	Chartwell RX, LLC	40509b3c-b725-400c-abe5-d6d5714d405d	2025-12-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205245 application number: ANDA205245
Metronidazole	METRONIDAZOLE	Major Pharmaceuticals	71f5ce2f-17f8-45fc-b27d-2bf982591ab3	2025-01-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205245 application number: ANDA205245 ndc (product): 0904-7156 ndc (product): 0904-7126
Metronidazole	METRONIDAZOLE	NuCare Pharmaceuticals,Inc.	a860b097-7447-a3b7-e053-2995a90a4bfd	2024-12-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205245 application number: ANDA205245 ndc (product): 68071-5283
Metronidazole	METRONIDAZOLE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	d9e33638-3803-426e-a1c3-7d0cf145d92f	2024-07-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205245 application number: ANDA205245 ndc (product): 23155-651 ndc (product): 23155-652
Metronidazole	METRONIDAZOLE	NuCare Pharmaceuticals,Inc.	ae2e4bbe-8c12-4af9-e053-2a95a90af299	2024-07-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205245 application number: ANDA205245 ndc (product): 68071-2251

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 37 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0904-7126	Metronidazole	METRONIDAZOLE	Major Pharmaceuticals	ANDA	Current
0904-7126	Metronidazole	METRONIDAZOLE	Major Pharmaceuticals	ANDA	Current
0904-7126	Metronidazole	METRONIDAZOLE	Major Pharmaceuticals	ANDA	Current
0904-7156	Metronidazole	METRONIDAZOLE	Major Pharmaceuticals	ANDA	Current
0904-7156	Metronidazole	METRONIDAZOLE	Major Pharmaceuticals	ANDA	Current
23155-651	Metronidazole	METRONIDAZOLE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-651	Metronidazole	METRONIDAZOLE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-651	Metronidazole	METRONIDAZOLE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-651	Metronidazole	METRONIDAZOLE	Heritage Pharmaceuticals Inc	ANDA	Current
23155-652	Metronidazole	METRONIDAZOLE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-652	Metronidazole	METRONIDAZOLE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-652	Metronidazole	METRONIDAZOLE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-652	Metronidazole	METRONIDAZOLE	Heritage Pharmaceuticals Inc	ANDA	Current
50090-4494	Metronidazole	METRONIDAZOLE	A-S Medication Solutions	ANDA	Current
53217-264	Metronidazole	Metronidazole	Aidarex Pharmaceuticals LLC	ANDA	Current
55700-476	Metronidazole	Metronidazole	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
64980-235	Metronidazole	Metronidazole	Rising Pharmaceuticals, Inc.	ANDA	Current
64980-236	Metronidazole	Metronidazole	Rising Pharmaceuticals, Inc.	ANDA	Current
68071-2251	Metronidazole	METRONIDAZOLE	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2251	Metronidazole	METRONIDAZOLE	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5283	Metronidazole	METRONIDAZOLE	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5283	Metronidazole	METRONIDAZOLE	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5283	Metronidazole	METRONIDAZOLE	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-6843	Metronidazole	Metronidazole	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-6843	Metronidazole	Metronidazole	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-6843	Metronidazole	Metronidazole	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7739	Metronidazole	METRONIDAZOLE	Preferred Pharmaceuticals, Inc.	ANDA	Current
70518-3073	Metronidazole	METRONIDAZOLE	REMEDYREPACK INC.	ANDA	Current
70518-3073	Metronidazole	METRONIDAZOLE	REMEDYREPACK INC.	ANDA	Current
70518-3073	Metronidazole	METRONIDAZOLE	REMEDYREPACK INC.	ANDA	Current
70518-3073	Metronidazole	METRONIDAZOLE	REMEDYREPACK INC.	ANDA	Current
70518-3265	Metronidazole	METRONIDAZOLE	REMEDYREPACK INC.	ANDA	Current
70518-3265	Metronidazole	METRONIDAZOLE	REMEDYREPACK INC.	ANDA	Current
70518-3265	Metronidazole	METRONIDAZOLE	REMEDYREPACK INC.	ANDA	Current
70934-970	Metronidazole	METRONIDAZOLE	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
71335-1609	Metronidazole	METRONIDAZOLE	Bryant Ranch Prepack	ANDA	Current
71335-1609	Metronidazole	METRONIDAZOLE	Bryant Ranch Prepack	ANDA	Current