Application 079067

Type: ANDA
Sponsor: ALEMBIC PHARMS 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
A079067-001	METRONIDAZOLE	METRONIDAZOLE	250MG	TABLET / ORAL	AB		2009-03-13
A079067-002	METRONIDAZOLE	METRONIDAZOLE	500MG	TABLET / ORAL	AB		2009-03-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A079067-001	AB
A079067-002	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	A079067-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2009-03-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079067-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2009-03-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079067-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2009-03-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079067-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2009-03-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079067-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2009-03-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079067-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2009-03-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079067-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2009-03-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079067-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2009-03-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079067-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2009-03-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079067-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2009-03-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079067-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2009-03-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079067-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2009-03-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079067-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2009-03-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079067-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2009-03-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079067-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2009-03-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079067-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2009-03-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079067-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2009-03-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079067-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2009-03-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079067-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2009-03-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079067-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2009-03-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079067-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2009-03-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079067-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2009-03-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079067-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2009-03-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079067-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2009-03-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079067-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2009-03-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079067-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2009-03-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079067-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2009-03-13	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A079067-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2009-03-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079067-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2009-03-13	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079067-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2009-03-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A079067-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2009-03-13	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A079067-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2009-03-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A079067-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2009-03-13	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A079067-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2009-03-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A079067-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2009-03-13	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A079067-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2009-03-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A079067-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2009-03-13	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A079067-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2009-03-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A079067-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2009-03-13	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A079067-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2009-03-13	`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	A079067-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079067-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079067-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079067-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079067-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079067-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079067-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079067-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079067-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079067-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079067-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079067-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079067-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079067-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079067-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079067-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079067-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079067-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079067-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079067-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079067-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079067-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079067-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079067-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079067-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079067-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079067-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A079067-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079067-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079067-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A079067-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A079067-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A079067-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A079067-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A079067-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A079067-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A079067-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A079067-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A079067-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A079067-002	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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Metronidazole	METRONIDAZOLE	PD-Rx Pharmaceuticals, Inc.	aea4e2a1-2089-40dc-9eee-deaab4f21397	2025-10-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079067 application number: ANDA079067 ndc (product): 72789-007
Metronidazole	METRONIDAZOLE	PD-Rx Pharmaceuticals, Inc.	b85bdc1f-1ffb-40d5-a407-e8de2891996d	2025-10-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079067 application number: ANDA079067 ndc (product): 72789-011
Metronidazole	METRONIDAZOLE	Bryant Ranch Prepack	8522493d-0a18-49dd-8d49-bd159f6ee332	2024-10-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079067 application number: ANDA079067 ndc (product): 71335-1681
Metronidazole	METRONIDAZOLE	NuCare Pharmaceuticals,Inc.	b2bd62c2-c6ed-f459-e053-2a95a90a90eb	2024-07-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079067 application number: ANDA079067 ndc (product): 68071-2288
Metronidazole	METRONIDAZOLE	Alembic Pharmaceuticals Inc.	b1fcf023-cdfd-45b7-b4d4-ff814f33ee79	2024-07-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079067 application number: ANDA079067 ndc (product): 62332-017 ndc (product): 62332-016
Metronidazole	METRONIDAZOLE	NuCare Pharmaceuticals,Inc.	937913b8-c131-6339-e053-2a95a90a4dd9	2024-06-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079067 application number: ANDA079067 ndc (product): 68071-5073
Metronidazole	METRONIDAZOLE	Alembic Pharmaceuticals Limited	d7455566-16aa-488a-af2a-93b55a04c02f	2023-01-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079067 application number: ANDA079067 ndc (product): 46708-428 ndc (product): 46708-429
Metronidazole	METRONIDAZOLE	AvPAK	9623181f-5e3b-3695-e053-2a95a90a99f6	2022-05-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079067 application number: ANDA079067 ndc (product): 50268-534 ndc (product): 50268-535

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 58 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
46708-428	Metronidazole	Metronidazole	Alembic Pharmaceuticals Limited	ANDA	Current
46708-428	Metronidazole	Metronidazole	Alembic Pharmaceuticals Limited	ANDA	Current
46708-429	Metronidazole	Metronidazole	Alembic Pharmaceuticals Limited	ANDA	Current
46708-429	Metronidazole	Metronidazole	Alembic Pharmaceuticals Limited	ANDA	Current
50268-534	Metronidazole	Metronidazole	AvPAK	ANDA	Current
50268-534	Metronidazole	Metronidazole	AvPAK	ANDA	Current
50268-534	Metronidazole	Metronidazole	AvPAK	ANDA	Current
50268-534	Metronidazole	Metronidazole	AvPAK	ANDA	Current
50268-535	Metronidazole	Metronidazole	AvPAK	ANDA	Current
50268-535	Metronidazole	Metronidazole	AvPAK	ANDA	Current
50268-535	Metronidazole	Metronidazole	AvPAK	ANDA	Current
50268-535	Metronidazole	Metronidazole	AvPAK	ANDA	Current
51655-123	Metronidazole	Metronidazole	Northwind Pharmaceuticals	ANDA	Current
51655-190	Metronidazole	Metronidazole	Northwind Pharmaceuticals	ANDA	Current
61919-385	METRONIDAZOLE	METRONIDAZOLE	DIRECT RX	ANDA	Current
61919-385	METRONIDAZOLE	METRONIDAZOLE	DIRECT RX	ANDA	Current
61919-788	Metronidazole	Metronidazole	Direct Rx	ANDA	Current
61919-788	Metronidazole	Metronidazole	Direct Rx	ANDA	Current
62332-016	Metronidazole	Metronidazole	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-016	Metronidazole	Metronidazole	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-016	Metronidazole	Metronidazole	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-016	Metronidazole	Metronidazole	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-017	Metronidazole	Metronidazole	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-017	Metronidazole	Metronidazole	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-017	Metronidazole	Metronidazole	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-017	Metronidazole	Metronidazole	Alembic Pharmaceuticals Inc.	ANDA	Current
63187-711	Metronidazole	Metronidazole	Proficient Rx LP	ANDA	Current
66267-147	Metronidazole	Metronidazole	NuCare Pharmaceuticlas, Inc.	ANDA	Current
66267-147	Metronidazole	Metronidazole	NuCare Pharmaceuticlas, Inc.	ANDA	Current
66267-148	Metronidazole	Metronidazole	NuCare Pharmaceuticals, Inc.	ANDA	Current
66267-148	Metronidazole	Metronidazole	NuCare Pharmaceuticals, Inc.	ANDA	Current
66267-804	Metronidazole	Metronidazole	NuCare Pharmaceuticals, Inc.	ANDA	Current
66267-804	Metronidazole	Metronidazole	NuCare Pharmaceuticals, Inc.	ANDA	Current
66267-804	Metronidazole	Metronidazole	NuCare Pharmaceuticals, Inc.	ANDA	Current
66267-805	Metronidazole	Metronidazole	NuCare Pharmaceuticals, Inc.	ANDA	Current
66267-805	Metronidazole	Metronidazole	NuCare Pharmaceuticals, Inc.	ANDA	Current
68071-2288	Metronidazole	Metronidazole	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2288	Metronidazole	Metronidazole	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5073	Metronidazole	Metronidazole	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5073	Metronidazole	Metronidazole	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-7557	Metronidazole	Metronidazole	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7557	Metronidazole	Metronidazole	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9372	Metronidazole	Metronidazole	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9397	Metronidazole	Metronidazole	Preferred Pharmaceuticals, Inc.	ANDA	Current
71335-1681	Metronidazole	Metronidazole	Bryant Ranch Prepack	ANDA	Current
71335-1681	Metronidazole	Metronidazole	Bryant Ranch Prepack	ANDA	Current
72789-007	Metronidazole	Metronidazole	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-007	Metronidazole	Metronidazole	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-007	Metronidazole	Metronidazole	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-007	Metronidazole	Metronidazole	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-007	Metronidazole	Metronidazole	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-007	Metronidazole	Metronidazole	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-007	Metronidazole	Metronidazole	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-011	Metronidazole	Metronidazole	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-011	Metronidazole	Metronidazole	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-011	Metronidazole	Metronidazole	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-011	Metronidazole	Metronidazole	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-011	Metronidazole	Metronidazole	PD-Rx Pharmaceuticals, Inc.	ANDA	Current