Application 070772

Type: ANDA
Sponsor: INNOGENIX

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
003	METRONIDAZOLE	METRONIDAZOLE	TABLET;ORAL	125MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A070772-001	METRONIDAZOLE	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1986-07-16
A070772-002	METRONIDAZOLE	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1986-07-16
A070772-003	METRONIDAZOLE	METRONIDAZOLE	125MG	TABLET / ORAL		2024-10-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A070772-001	AB
A070772-002	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 · 91 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	A070772-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1986-07-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070772-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1986-07-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070772-003	METRONIDAZOLE	125MG	TABLET / ORAL		2024-10-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070772-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1986-07-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070772-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1986-07-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070772-003	METRONIDAZOLE	125MG	TABLET / ORAL		2024-10-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070772-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1986-07-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070772-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1986-07-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070772-003	METRONIDAZOLE	125MG	TABLET / ORAL		2024-10-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070772-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1986-07-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070772-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1986-07-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070772-003	METRONIDAZOLE	125MG	TABLET / ORAL		2024-10-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070772-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1986-07-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070772-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1986-07-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070772-003	METRONIDAZOLE	125MG	TABLET / ORAL		2024-10-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070772-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1986-07-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070772-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1986-07-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070772-003	METRONIDAZOLE	125MG	TABLET / ORAL		2024-10-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070772-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1986-07-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070772-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1986-07-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070772-003	METRONIDAZOLE	125MG	TABLET / ORAL		2024-10-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070772-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1986-07-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070772-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1986-07-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070772-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1986-07-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070772-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1986-07-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070772-003	METRONIDAZOLE	125MG	TABLET / ORAL		2024-10-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070772-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1986-07-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A070772-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1986-07-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070772-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1986-07-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070772-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1986-07-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070772-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1986-07-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070772-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1986-07-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070772-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1986-07-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070772-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1986-07-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070772-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1986-07-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A070772-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1986-07-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070772-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1986-07-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070772-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1986-07-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A070772-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1986-07-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A070772-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1986-07-16	`5d02ea3f76ae…`

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	A070772-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070772-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070772-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070772-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070772-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070772-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070772-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070772-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070772-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070772-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070772-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070772-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070772-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070772-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070772-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070772-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070772-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070772-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070772-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A070772-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070772-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070772-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070772-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070772-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070772-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070772-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070772-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A070772-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070772-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070772-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A070772-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A070772-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A070772-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A070772-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A070772-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A070772-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A070772-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A070772-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A070772-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A070772-002	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	Bryant Ranch Prepack	99886f54-4ebe-4a2d-b779-bcfbb0634db1	2026-06-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070772 application number: ANDA070772
metronidazole	METRONIDAZOLE	Method Pharmaceuticals LLC	2ae49bf4-a23b-bdcc-e063-6294a90a80a9	2026-05-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070772 application number: ANDA070772
Metronidazole	METRONIDAZOLE	Cardinal Health 107, LLC	9ed89bfc-ccf3-4e6c-924f-2a14bf82163f	2026-01-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070772 application number: ANDA070772 ndc (product): 55154-8190
Metronidazole	METRONIDAZOLE	American Health Packaging	c90da73c-e48e-411a-bd75-0b107f1141cc	2026-01-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070772 application number: ANDA070772 ndc (product): 60687-550 ndc (product): 60687-526
metronidazole	METRONIDAZOLE	Bryant Ranch Prepack	ac7e80ce-6174-4246-a955-a92adc516571	2025-10-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070772 application number: ANDA070772
metronidazole	METRONIDAZOLE	Golden State Medical Supply, Inc.	a6ceb47b-d0b0-d377-e053-2995a90a463e	2025-06-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070772 application number: ANDA070772 ndc (product): 51407-376
metronidazole	METRONIDAZOLE	Golden State Medical Supply, Inc.	a6ce16b7-25c5-48aa-e053-2a95a90aa947	2025-05-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070772 application number: ANDA070772 ndc (product): 51407-372
metronidazole	METRONIDAZOLE	AMICI PHARMA INC	9f1fec88-097f-42b9-a36f-214648d7eebb	2025-04-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070772 application number: ANDA070772 ndc (product): 69292-208
metronidazole	METRONIDAZOLE	AMICI PHARMA INC	4920fcf7-5ceb-46e9-82e0-dc508900bb91	2025-04-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070772 application number: ANDA070772 ndc (product): 69292-206 ndc (product): 69292-207

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 42 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
51407-014	metronidazole	metronidazole	Golden State Medical Supply Inc	ANDA	Current
51407-014	metronidazole	metronidazole	Golden State Medical Supply, Inc.	ANDA	Current
51407-014	metronidazole	metronidazole	Golden State Medical Supply	ANDA	Current
51407-014	metronidazole	metronidazole	Golden State Medical Supply	ANDA	Current
51407-372	metronidazole	metronidazole	Golden State Medical Supply	ANDA	Current
51407-372	metronidazole	metronidazole	Golden State Medical Supply	ANDA	Current
51407-372	metronidazole	metronidazole	Golden State Medical Supply, Inc.	ANDA	Current
51407-372	metronidazole	metronidazole	Golden State Medical Supply, Inc.	ANDA	Current
51407-376	metronidazole	metronidazole	Golden State Medical Supply	ANDA	Current
51407-376	metronidazole	metronidazole	Golden State Medical Supply	ANDA	Current
51407-376	metronidazole	metronidazole	Golden State Medical Supply, Inc.	ANDA	Current
51407-376	metronidazole	metronidazole	Golden State Medical Supply, Inc.	ANDA	Current
55154-8182	Metronidazole	Metronidazole	Cardinal Health	ANDA	Current
55154-8182	Metronidazole	Metronidazole	Cardinal Health	ANDA	Current
55154-8182	Metronidazole	Metronidazole	Cardinal Health	ANDA	Current
55154-8190	Metronidazole	Metronidazole	Cardinal Health	ANDA	Current
57664-653	Metronidazole	Metronidazole	Sun Pharmaceutical Industries, Inc.	ANDA	Current
58657-683	Metronidazole	Metronidazole	Method Pharmaceuticals, LLC	ANDA	Current
58657-684	Metronidazole	Metronidazole	Method Pharmaceuticals, LLC	ANDA	Current
60687-424	Metronidazole	Metronidazole	American Health Packaging	ANDA	Current
60687-424	Metronidazole	Metronidazole	American Health Packaging	ANDA	Current
60687-424	Metronidazole	Metronidazole	American Health Packaging	ANDA	Current
60687-526	Metronidazole	Metronidazole	American Health Packaging	ANDA	Current
60687-526	Metronidazole	Metronidazole	American Health Packaging	ANDA	Current
60687-526	Metronidazole	Metronidazole	American Health Packaging	ANDA	Current
60687-550	Metronidazole	Metronidazole	American Health Packaging	ANDA	Current
60687-550	Metronidazole	Metronidazole	American Health Packaging	ANDA	Current
60687-550	Metronidazole	Metronidazole	American Health Packaging	ANDA	Current
67296-1806	metronidazole	metronidazole	RedPharm Drug, Inc.	ANDA	Current
67296-1806	metronidazole	metronidazole	RedPharm Drug, Inc.	ANDA	Current
69292-206	metronidazole	metronidazole	AMICI PHARMACEUTICALS LLC	ANDA	Current
69292-206	metronidazole	metronidazole	AMICI PHARMACEUTICALS LLC	ANDA	Current
69292-207	metronidazole	metronidazole	AMICI PHARMACEUTICALS LLC	ANDA	Current
69292-207	metronidazole	metronidazole	AMICI PHARMACEUTICALS LLC	ANDA	Current
69292-207	metronidazole	metronidazole	AMICI PHARMACEUTICALS LLC	ANDA	Current
69292-207	metronidazole	metronidazole	AMICI PHARMACEUTICALS LLC	ANDA	Current
69292-208	metronidazole	metronidazole	AMICI PHARMACEUTICALS LLC	ANDA	Current
69292-208	metronidazole	metronidazole	AMICI PHARMACEUTICALS LLC	ANDA	Current
69292-208	metronidazole	metronidazole	AMICI PHARMACEUTICALS LLC	ANDA	Current
69292-208	metronidazole	metronidazole	AMICI PHARMACEUTICALS LLC	ANDA	Current
70934-801	metronidazole	metronidazole	Denton Pharma, Inc. dba Northwind Pharmaceuticals	ANDA	Current
70934-801	metronidazole	metronidazole	Denton Pharma, Inc. dba Northwind Pharmaceuticals	ANDA	Current