Application 203458

Type: ANDA
Sponsor: UNICHEM LABS 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 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
A203458-001	METRONIDAZOLE	METRONIDAZOLE	250MG	TABLET / ORAL	AB		2014-01-22
A203458-002	METRONIDAZOLE	METRONIDAZOLE	500MG	TABLET / ORAL	AB		2014-01-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203458-001	AB
A203458-002	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	A203458-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2014-01-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203458-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2014-01-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203458-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2014-01-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203458-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2014-01-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203458-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2014-01-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203458-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2014-01-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203458-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2014-01-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203458-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2014-01-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203458-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2014-01-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203458-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2014-01-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203458-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2014-01-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203458-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2014-01-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203458-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2014-01-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203458-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2014-01-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203458-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2014-01-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203458-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2014-01-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203458-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2014-01-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203458-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2014-01-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203458-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2014-01-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203458-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2014-01-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203458-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2014-01-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203458-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2014-01-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203458-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2014-01-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203458-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2014-01-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203458-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2014-01-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203458-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2014-01-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203458-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2014-01-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203458-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2014-01-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203458-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2014-01-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203458-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2014-01-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203458-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2014-01-22	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203458-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2014-01-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203458-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2014-01-22	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203458-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2014-01-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203458-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2014-01-22	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203458-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2014-01-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203458-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2014-01-22	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203458-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2014-01-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203458-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2014-01-22	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203458-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2014-01-22	`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	A203458-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203458-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203458-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203458-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203458-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203458-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203458-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203458-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203458-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203458-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203458-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203458-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203458-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203458-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203458-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203458-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203458-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203458-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203458-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203458-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203458-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203458-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203458-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203458-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203458-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203458-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203458-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203458-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203458-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203458-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203458-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203458-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203458-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203458-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203458-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203458-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203458-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203458-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203458-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203458-002	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 2 · 31 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Metronidazole	METRONIDAZOLE	REMEDYREPACK INC.	2f7d84d4-1085-4243-be88-442eecb85205	2026-07-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203458 application number: ANDA203458
Metronidazole	METRONIDAZOLE	REMEDYREPACK INC.	cfeab9e3-58b9-4890-9185-11b62904e2af	2026-07-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203458 application number: ANDA203458
Metronidazole	METRONIDAZOLE	Preferred Pharmaceuticals Inc.	cbee69e8-029c-49d2-89cd-f504b8e0ac28	2026-07-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203458 application number: ANDA203458
Metronidazole	METRONIDAZOLE	Preferred Pharmaceuticals Inc.	3e0a14f1-961b-4722-bfea-aafcc5d7706c	2026-07-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203458 application number: ANDA203458
Metronidazole	METRONIDAZOLE	REMEDYREPACK INC.	49bed450-7fa8-401c-8c8c-afc1c61d473a	2026-06-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203458 application number: ANDA203458
Metronidazole	METRONIDAZOLE	REMEDYREPACK INC.	3c0ebb00-a0ae-4f64-9bfc-de01193191e8	2026-06-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203458 application number: ANDA203458
Metronidazole	METRONIDAZOLE	Coupler LLC	545f2900-745c-c33c-e063-6294a90a5e4f	2026-06-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203458 application number: ANDA203458
Metronidazole	METRONIDAZOLE	Coupler LLC	509c8d03-e199-8154-e063-6394a90afddc	2026-04-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203458 application number: ANDA203458
Metronidazole	METRONIDAZOLE	St. Mary's Medical Park Pharmacy	60689b96-cb58-925a-e053-2a91aa0a32a3	2026-04-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203458 application number: ANDA203458
Metronidazole	METRONIDAZOLE	Bryant Ranch Prepack	1277591d-ccf4-428a-b647-cb1ef3fbf561	2026-04-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203458 application number: ANDA203458
Metronidazole	METRONIDAZOLE	A-S Medication Solutions	02046a22-a5eb-4bb7-bec7-e5a2aa55e142	2026-03-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203458 application number: ANDA203458
Metronidazole	METRONIDAZOLE	BluePoint Laboratories	3cf021b6-5794-4a86-b09d-bece0ba8b302	2026-02-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203458 application number: ANDA203458
METRONIDAZOLE	METRONIDAZOLE	Direct_Rx	90a5acb3-f8cc-1e82-e053-2995a90a4e97	2026-01-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203458 application number: ANDA203458
Metronidazole	METRONIDAZOLE	Proficient Rx LP	a56c2842-8ad4-4396-8eb6-cbcd1629fcb1	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203458 application number: ANDA203458
Metronidazole	METRONIDAZOLE	NuCare Pharmaceuticals, Inc.	4040db14-750f-6d20-e054-00144ff8d46c	2025-12-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203458 application number: ANDA203458
Metronidazole	METRONIDAZOLE	Redpharm Drug	32523df9-8c47-200f-e063-6294a90ac890	2025-12-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203458 application number: ANDA203458
Metronidazole	METRONIDAZOLE	A-S Medication Solutions	60ad086d-6f54-4134-b608-53a6ff571ff8	2025-12-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203458 application number: ANDA203458
Metronidazole	METRONIDAZOLE	A-S Medication Solutions	2a5af710-dbf7-41c1-9b3a-35e69b3fa4ab	2025-12-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203458 application number: ANDA203458
Metronidazole	METRONIDAZOLE	A-S Medication Solutions	9a18debb-3bb8-4b23-949b-aaa0f3b62191	2025-12-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203458 application number: ANDA203458
Metronidazole	METRONIDAZOLE	PD-Rx Pharmaceuticals, Inc.	353b7f5b-4bbc-4ec9-84ba-d82656ea1811	2025-10-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203458 application number: ANDA203458

NDC Listings For This Application#

NDC listings for this application page 3 of 3 · 174 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70934-104	Metronidazole	Metronidazole	Denton Pharma, Inc. dba Northwind Pharmaceuticals	ANDA	Current
70934-104	Metronidazole	Metronidazole	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-276	Metronidazole	Metronidazole	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-276	Metronidazole	Metronidazole	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-524	Metronidazole	Metronidazole	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-524	Metronidazole	Metronidazole	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
71335-0358	Metronidazole	Metronidazole	Bryant Ranch Prepack	ANDA	Current
71335-0358	Metronidazole	Metronidazole	Bryant Ranch Prepack	ANDA	Current
71335-0358	Metronidazole	Metronidazole	Bryant Ranch Prepack	ANDA	Current
72789-005	Metronidazole	Metronidazole	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-005	Metronidazole	Metronidazole	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-005	Metronidazole	Metronidazole	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-005	Metronidazole	Metronidazole	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-005	Metronidazole	Metronidazole	PD-Rx Pharmaceuticals, Inc.	ANDA	Current