Application 070027

Type: ANDA
Sponsor: TEVA PHARMS USA

Application Products#

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

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

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A070027-001	METRONIDAZOLE	METRONIDAZOLE	250MG	TABLET / ORAL	AB		1984-11-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A070027-001	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 2 · 41 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	A070027-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1984-11-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070027-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1984-11-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070027-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1984-11-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070027-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1984-11-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070027-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1984-11-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070027-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1984-11-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070027-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1984-11-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070027-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1984-11-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070027-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1984-11-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070027-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1984-11-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070027-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1984-11-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070027-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1984-11-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070027-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1984-11-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070027-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1984-11-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070027-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1984-11-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A070027-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1984-11-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A070027-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1984-11-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A070027-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1984-11-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A070027-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1984-11-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A070027-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1984-11-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A070027-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1984-11-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A070027-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1984-11-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A070027-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1984-11-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A070027-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1984-11-06	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A070027-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1984-11-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A070027-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1984-11-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A070027-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1984-11-06	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A070027-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1984-11-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A070027-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1984-11-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A070027-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1984-11-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A070027-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1984-11-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A070027-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1984-11-06	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A070027-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1984-11-06	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A070027-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1984-11-06	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A070027-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1984-11-06	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A070027-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1984-11-06	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A070027-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1984-11-06	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A070027-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1984-11-06	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A070027-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1984-11-06	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A070027-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1984-11-06	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A070027-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070027-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070027-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070027-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070027-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070027-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070027-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070027-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070027-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070027-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070027-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070027-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070027-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070027-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070027-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A070027-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A070027-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A070027-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A070027-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A070027-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A070027-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A070027-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A070027-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A070027-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A070027-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A070027-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A070027-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A070027-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A070027-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A070027-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A070027-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A070027-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A070027-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A070027-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A070027-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A070027-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A070027-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A070027-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A070027-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A070027-001	AB	1	`cb3db0bc1861…`

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Metronidazole	METRONIDAZOLE	REMEDYREPACK INC.	ca450fad-0513-4c45-8ea0-1f46bcbf6a36	2026-03-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070027 application number: ANDA070027 ndc (product): 70518-0013
Metronidazole	METRONIDAZOLE	Bryant Ranch Prepack	8e1f507b-22fa-4033-9b3e-5435f20ace66	2024-09-04	Boxed warning, Warnings, Adverse reactions	Exact identifier ndc (product): 63629-1388
Metronidazole	METRONIDAZOLE	Bryant Ranch Prepack	ea635d05-b3c1-4f49-ace2-d091c20920da	2024-08-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070027 application number: ANDA070027 ndc (product): 71335-0858
Metronidazole	METRONIDAZOLE	Teva Pharmaceuticals USA, Inc.	291a45f6-ed27-4dcc-8364-358d08623797	2024-07-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070027 application number: ANDA070027 ndc (product): 50111-333
Metronidazole	METRONIDAZOLE	Proficient Rx LP	205054e1-8172-47dc-931c-a18a60e7e9f0	2022-12-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070027 application number: ANDA070027 ndc (product): 63187-511

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 52 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0440-1795	Metronidazole	Metronidazole	Liberty Pharmaceuticals, Inc.	ANDA	Current
0904-1453	Metronidazole	Metronidazole	Major Pharmaceuticals	ANDA	Current
0904-1453	Metronidazole	Metronidazole	Major Pharmaceuticals	ANDA	Current
0904-1453	Metronidazole	Metronidazole	Major Pharmaceuticals	ANDA	Current
21695-308	Metronidazole	Metronidazole	Rebel Distributors Corp	ANDA	Current
50090-0202	Metronidazole	Metronidazole	A-S Medication Solutions	ANDA	Current
50090-0202	Metronidazole	Metronidazole	A-S Medication Solutions	ANDA	Current
50090-0202	Metronidazole	Metronidazole	A-S Medication Solutions	ANDA	Current
50111-333	Metronidazole	Metronidazole	Teva Pharmaceuticals USA, Inc.	ANDA	Current
50111-333	Metronidazole	Metronidazole	Teva Pharmaceuticals USA, Inc.	ANDA	Current
50111-333	Metronidazole	Metronidazole	Teva Pharmaceuticals USA, Inc.	ANDA	Current
50111-333	Metronidazole	Metronidazole	Teva Pharmaceuticals USA, Inc.	ANDA	Current
50111-333	Metronidazole	Metronidazole	Teva Pharmaceuticals USA, Inc.	ANDA	Current
50111-333	Metronidazole	Metronidazole	Teva Pharmaceuticals USA, Inc.	ANDA	Current
52959-400	Metronidazole	Metronidazole	H.J. Harkins Company, Inc.	ANDA	Current
53808-0474	Metronidazole	Metronidazole	State of Florida DOH Central Pharmacy	ANDA	Current
55154-0663	Metronidazole	Metronidazole	Cardinal Health	ANDA	Current
55154-0663	Metronidazole	Metronidazole	Cardinal Health	ANDA	Current
55154-0663	Metronidazole	Metronidazole	Cardinal Health 107, LLC	ANDA	Current
55289-172	Metronidazole	Metronidazole	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55695-011	Metronidazole	Metronidazole	Department of State Health Services, Pharmacy Branch	ANDA	Current
63187-511	Metronidazole	Metronidazole	Proficient Rx LP	ANDA	Current
63187-511	Metronidazole	Metronidazole	Proficient Rx LP	ANDA	Current
63187-511	Metronidazole	Metronidazole	Proficient Rx LP	ANDA	Current
63187-511	Metronidazole	Metronidazole	Proficient Rx LP	ANDA	Current
63629-1388	Metronidazole	Metronidazole	Bryant Ranch Prepack	ANDA	Current
63629-1388	Metronidazole	Metronidazole	Bryant Ranch Prepack	ANDA	Current
63629-7754	Metronidazole	Metronidazole	Bryant Ranch Prepack	ANDA	Current
63629-7754	Metronidazole	Metronidazole	Bryant Ranch Prepack	ANDA	Current
64205-333	Metronidazole	Metronidazole	ReadyMeds	ANDA	Current
68151-2007	Metronidazole	Metronidazole	Carilion Materials Management	ANDA	Current
68788-9082	Metronidazole	Metronidazole	Preferred Pharmaceuticals, Inc.	ANDA	Current
70518-0013	Metronidazole	Metronidazole	REMEDYREPACK INC.	ANDA	Current
70518-0013	Metronidazole	Metronidazole	REMEDYREPACK INC.	ANDA	Current
70518-0013	Metronidazole	Metronidazole	REMEDYREPACK INC.	ANDA	Current
70518-0013	Metronidazole	Metronidazole	REMEDYREPACK INC.	ANDA	Current
70518-0013	Metronidazole	Metronidazole	REMEDYREPACK INC.	ANDA	Current
70518-0013	Metronidazole	Metronidazole	REMEDYREPACK INC.	ANDA	Current
70518-0090	Metronidazole	Metronidazole	REMEDYREPACK INC.	ANDA	Current
70518-0090	Metronidazole	Metronidazole	REMEDYREPACK INC.	ANDA	Current
70518-0090	Metronidazole	Metronidazole	REMEDYREPACK INC.	ANDA	Current
70518-0324	Metronidazole	Metronidazole	REMEDYREPACK INC.	ANDA	Current
70518-0324	Metronidazole	Metronidazole	REMEDYREPACK INC.	ANDA	Current
70518-0324	Metronidazole	Metronidazole	REMEDYREPACK INC.	ANDA	Current
70518-0324	Metronidazole	Metronidazole	REMEDYREPACK INC.	ANDA	Current
70518-0324	Metronidazole	Metronidazole	REMEDYREPACK INC.	ANDA	Current
70518-0324	Metronidazole	Metronidazole	REMEDYREPACK INC.	ANDA	Current
70518-0324	Metronidazole	Metronidazole	REMEDYREPACK INC.	ANDA	Current
71335-0858	Metronidazole	Metronidazole	Bryant Ranch Prepack	ANDA	Current
71335-0858	Metronidazole	Metronidazole	Bryant Ranch Prepack	ANDA	Current
71335-0858	Metronidazole	Metronidazole	Bryant Ranch Prepack	ANDA	Current
76413-114	Metronidazole	Metronidazole	Central Texas Community Health Centers	ANDA	Current