Application 203974

Type: ANDA
Sponsor: AUROBINDO PHARMA LTD

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 42.

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
A203974-001	METRONIDAZOLE	METRONIDAZOLE	250MG	TABLET / ORAL	AB		2015-05-29
A203974-002	METRONIDAZOLE	METRONIDAZOLE	500MG	TABLET / ORAL	AB	RS	2015-05-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203974-001	AB
A203974-002	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 · 84 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
2026-08-18 06:07:40	2026-07	A203974-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB		2015-05-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203974-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	RS	2015-05-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203974-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB		2015-05-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203974-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	RS	2015-05-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203974-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB		2015-05-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203974-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	RS	2015-05-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203974-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB		2015-05-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203974-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	RS	2015-05-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203974-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB		2015-05-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203974-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	RS	2015-05-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203974-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB		2015-05-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203974-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	RS	2015-05-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203974-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB		2015-05-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203974-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	RS	2015-05-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203974-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB		2015-05-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203974-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	RS	2015-05-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203974-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB		2015-05-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203974-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	RS	2015-05-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203974-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB		2015-05-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203974-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	RS	2015-05-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203974-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB		2015-05-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203974-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	RS	2015-05-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203974-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB		2015-05-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203974-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	RS	2015-05-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203974-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB		2015-05-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203974-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	RS	2015-05-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203974-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB		2015-05-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203974-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	RS	2015-05-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203974-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB		2015-05-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203974-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	RS	2015-05-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203974-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB		2015-05-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203974-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB		2015-05-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203974-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB		2015-05-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203974-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB		2015-05-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203974-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB		2015-05-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203974-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB		2015-05-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203974-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB		2015-05-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203974-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB		2015-05-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203974-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB		2015-05-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203974-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB		2015-05-29	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A203974-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203974-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203974-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203974-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203974-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203974-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203974-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203974-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203974-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203974-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203974-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203974-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203974-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203974-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203974-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203974-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203974-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203974-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203974-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203974-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203974-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203974-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203974-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203974-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203974-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203974-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203974-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203974-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203974-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203974-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203974-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203974-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203974-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203974-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203974-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203974-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203974-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203974-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203974-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203974-002	AB	1	`bb7c543d1eb4…`

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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Metronidazole	METRONIDAZOLE	REMEDYREPACK INC.	dc28753c-95ec-4b41-ad77-c4a66698d9db	2026-08-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203974 application number: ANDA203974 ndc (product): 70518-3110
Metronidazole	METRONIDAZOLE	NuCare Pharmaceuticals,Inc.	c225a455-ec25-2213-e053-2995a90a3389	2026-03-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203974 application number: ANDA203974 ndc (product): 68071-2399
Metronidazole	METRONIDAZOLE	Bryant Ranch Prepack	2fa14353-45df-429c-8759-7d66a65f08f0	2024-10-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203974 application number: ANDA203974 ndc (product): 71335-1838
Metronidazole	METRONIDAZOLE	Bryant Ranch Prepack	92e58420-1d99-4a92-b1f3-a7f791ca7187	2024-10-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203974 application number: ANDA203974 ndc (product): 71335-1922
Metronidazole	METRONIDAZOLE	Rising Pharma Holdings, Inc.	93e4f174-4fe0-4cfd-a0cf-d0963e082107	2024-09-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203974 application number: ANDA203974 ndc (product): 16571-664 ndc (product): 16571-665
Metronidazole	METRONIDAZOLE	Aurobindo Pharma Limited	f68397ee-67db-472e-8607-4300064e37df	2024-09-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203974 application number: ANDA203974 ndc (product): 65862-694 ndc (product): 65862-695
Metronidazole	METRONIDAZOLE	A-S Medication Solutions	bff2f5bd-75a4-4252-a643-c21741ae8a96	2023-02-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203974 application number: ANDA203974 ndc (product): 50090-5691

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 65 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16571-664	Metronidazole	Metronidazole	Rising Pharma Holdings, Inc.	ANDA	Current
16571-664	Metronidazole	Metronidazole	Rising Pharma Holdings, Inc.	ANDA	Current
16571-664	Metronidazole	Metronidazole	Rising Pharmaceuticals, Inc.	ANDA	Current
16571-664	Metronidazole	Metronidazole	Rising Pharma Holdings, Inc.	ANDA	Current
16571-665	Metronidazole	Metronidazole	Rising Pharma Holdings, Inc.	ANDA	Current
16571-665	Metronidazole	Metronidazole	Rising Pharma Holdings, Inc.	ANDA	Current
16571-665	Metronidazole	Metronidazole	Rising Pharmaceuticals, Inc.	ANDA	Current
16571-665	Metronidazole	Metronidazole	Rising Pharma Holdings, Inc.	ANDA	Current
50090-5687	Metronidazole	Metronidazole	A-S Medication Solutions	ANDA	Current
50090-5688	Metronidazole	Metronidazole	A-S Medication Solutions	ANDA	Current
50090-5691	Metronidazole	Metronidazole	A-S Medication Solutions	ANDA	Current
50090-5768	Metronidazole	Metronidazole	A-S Medication Solutions	ANDA	Current
50090-5787	Metronidazole	Metronidazole	A-S Medication Solutions	ANDA	Current
52343-095	Metronidazole	Metronidazole	LUCID PHARMA LLC	ANDA	Current
52343-096	Metronidazole	Metronidazole	LUCID PHARMA LLC	ANDA	Current
53002-2471	Metronidazole	Metronidazole	RPK Pharmaceuticals, Inc.	ANDA	Current
55700-909	Metronidazole	Metronidazole	Quality Care Products, LLC	ANDA	Current
55700-909	Metronidazole	Metronidazole	Quality Care Products, LLC	ANDA	Current
55700-909	Metronidazole	Metronidazole	Quality Care Products, LLC	ANDA	Current
55700-909	Metronidazole	Metronidazole	Quality Care Products, LLC	ANDA	Current
55700-909	Metronidazole	Metronidazole	Quality Care Products, LLC	ANDA	Current
55700-909	Metronidazole	Metronidazole	Quality Care Products, LLC	ANDA	Current
60760-664	Metronidazole	Metronidazole	St. Mary's Medical Park Pharmacy	ANDA	Current
60760-664	Metronidazole	Metronidazole	St. Mary's Medical Park Pharmacy	ANDA	Current
65862-694	Metronidazole	Metronidazole	Aurobindo Pharma Limited	ANDA	Current
65862-694	Metronidazole	Metronidazole	Aurobindo Pharma Limited	ANDA	Current
65862-694	Metronidazole	Metronidazole	Aurobindo Pharma Limited	ANDA	Current
65862-694	Metronidazole	Metronidazole	Aurobindo Pharma Limited	ANDA	Current
65862-694	Metronidazole	Metronidazole	Aurobindo Pharma Limited	ANDA	Current
65862-694	Metronidazole	Metronidazole	Aurobindo Pharma Limited	ANDA	Current
65862-695	Metronidazole	Metronidazole	Aurobindo Pharma Limited	ANDA	Current
65862-695	Metronidazole	Metronidazole	Aurobindo Pharma Limited	ANDA	Current
65862-695	Metronidazole	Metronidazole	Aurobindo Pharma Limited	ANDA	Current
65862-695	Metronidazole	Metronidazole	Aurobindo Pharma Limited	ANDA	Current
65862-695	Metronidazole	Metronidazole	Aurobindo Pharma Limited	ANDA	Current
65862-695	Metronidazole	Metronidazole	Aurobindo Pharma Limited	ANDA	Current
67296-1366	Metronidazole	Metronidazole	RedPharm Drug, Inc.	ANDA	Current
67296-1366	Metronidazole	Metronidazole	RedPharm Drug, Inc.	ANDA	Current
67296-1366	Metronidazole	Metronidazole	RedPharm Drug, Inc.	ANDA	Current
67296-1418	Metronidazole	Metronidazole	RedPharm Drug, Inc.	ANDA	Current
67296-1418	Metronidazole	Metronidazole	RedPharm Drug, Inc.	ANDA	Current
68071-2343	Metronidazole	Metronidazole	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2399	Metronidazole	Metronidazole	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2806	Metronidazole	Metronidazole	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2806	Metronidazole	Metronidazole	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2809	Metronidazole	Metronidazole	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2809	Metronidazole	Metronidazole	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-8230	Metronidazole	Metronidazole	Preferred Pharmaceuticals Inc.	ANDA	Current
69043-004	Metronidazole	Metronidazole	Cronus Pharma LLC	ANDA	Current
69043-004	Metronidazole	Metronidazole	Cronus Pharma LLC	ANDA	Current
69043-004	Metronidazole	Metronidazole	Cronus Pharma LLC	ANDA	Current
69043-004	Metronidazole	Metronidazole	Cronus Pharma LLC	ANDA	Current
69043-005	Metronidazole	Metronidazole	Cronus Pharma LLC	ANDA	Current
69043-005	Metronidazole	Metronidazole	Cronus Pharma LLC	ANDA	Current
69043-005	Metronidazole	Metronidazole	Cronus Pharma LLC	ANDA	Current
69043-005	Metronidazole	Metronidazole	Cronus Pharma LLC	ANDA	Current
70518-3110	Metronidazole	Metronidazole	REMEDYREPACK INC.	ANDA	Current
70518-3110	Metronidazole	Metronidazole	REMEDYREPACK INC.	ANDA	Current
70518-3110	Metronidazole	Metronidazole	REMEDYREPACK INC.	ANDA	Current
70934-813	Metronidazole	Metronidazole	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-956	Metronidazole	Metronidazole	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
71335-1838	Metronidazole	Metronidazole	Bryant Ranch Prepack	ANDA	Current
71335-1838	Metronidazole	Metronidazole	Bryant Ranch Prepack	ANDA	Current
71335-1922	Metronidazole	Metronidazole	Bryant Ranch Prepack	ANDA	Current
71335-1922	Metronidazole	Metronidazole	Bryant Ranch Prepack	ANDA	Current