Application 070033

Type: ANDA
Sponsor: PLIVA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A070033-001	METRONIDAZOLE	METRONIDAZOLE	500MG	TABLET / ORAL	AB		1984-12-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A070033-001	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	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`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	A070033-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070033-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070033-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070033-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070033-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070033-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070033-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070033-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070033-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070033-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070033-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070033-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070033-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070033-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070033-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A070033-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A070033-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A070033-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A070033-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A070033-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A070033-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A070033-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A070033-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A070033-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A070033-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A070033-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A070033-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A070033-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A070033-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A070033-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A070033-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A070033-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A070033-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A070033-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A070033-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A070033-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A070033-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A070033-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A070033-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A070033-001	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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Metronidazole	METRONIDAZOLE	REMEDYREPACK INC.	53918705-d2fe-4c6b-9501-a619a8ad3991	2026-07-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070033 application number: ANDA070033 ndc (product): 70518-1241
Metronidazole	METRONIDAZOLE	REMEDYREPACK INC.	1a28dce0-07af-401a-a6ac-1c2ee559c668	2026-01-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070033 application number: ANDA070033 ndc (product): 70518-1240
Metronidazole	METRONIDAZOLE	Redpharm Drug, inc.	f426cddc-8b70-c0a7-e053-2995a90a74e0	2025-04-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070033 application number: ANDA070033
Metronidazole	METRONIDAZOLE	Bryant Ranch Prepack	e1e7e127-e99e-80e9-1606-71261658b0c1	2024-11-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070033 application number: ANDA070033 ndc (product): 63629-1386
Metronidazole	METRONIDAZOLE	Proficient Rx LP	e313c7d9-fb7b-4d0f-bccf-cc72ac5ef205	2024-08-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070033 application number: ANDA070033 ndc (product): 63187-035
Metronidazole	METRONIDAZOLE	Teva Pharmaceuticals USA, Inc.	291a45f6-ed27-4dcc-8364-358d08623797	2024-07-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070033 application number: ANDA070033 ndc (product): 50111-334

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 60 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0179-1482	Metronidazole	Metronidazole	KAISER FOUNDATION HOSPITALS	ANDA	Current
0440-1796	Metronidazole	Metronidazole	Liberty Pharmaceuticals, Inc.	ANDA	Current
0615-7693	Metronidazole	Metronidazole	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
10544-265	Metronidazole	Metronidazole	Blenheim Pharmacal, Inc.	ANDA	Current
21695-309	Metronidazole	Metronidazole	Rebel Distributors Corp	ANDA	Current
42708-064	Metronidazole	Metronidazole	QPharma Inc	ANDA	Current
43063-021	Metronidazole	Metronidazole	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-021	Metronidazole	Metronidazole	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-021	Metronidazole	Metronidazole	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-021	Metronidazole	Metronidazole	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-021	Metronidazole	Metronidazole	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
49999-095	Metronidazole	Metronidazole	Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC	NDA	Current
50090-2512	Metronidazole	Metronidazole	A-S Medication Solutions	ANDA	Current
50090-2512	Metronidazole	Metronidazole	A-S Medication Solutions	ANDA	Current
50090-2513	Metronidazole	Metronidazole	A-S Medication Solutions	ANDA	Current
50090-2521	Metronidazole	Metronidazole	A-S Medication Solutions	ANDA	Current
50090-2647	Metronidazole	Metronidazole	A-S Medication Solutions	ANDA	Current
50111-334	Metronidazole	Metronidazole	Teva Pharmaceuticals USA, Inc.	ANDA	Current
50111-334	Metronidazole	Metronidazole	Teva Pharmaceuticals USA, Inc.	ANDA	Current
50111-334	Metronidazole	Metronidazole	Teva Pharmaceuticals USA, Inc.	ANDA	Current
50111-334	Metronidazole	Metronidazole	Teva Pharmaceuticals USA, Inc.	ANDA	Current
50111-334	Metronidazole	Metronidazole	Teva Pharmaceuticals USA, Inc.	ANDA	Current
50111-334	Metronidazole	Metronidazole	Teva Pharmaceuticals USA, Inc.	ANDA	Current
51655-189	METRONIDAZOLE	METRONIDAZOLE	Northwind Pharmaceuticals, LLC	ANDA	Current
52959-102	Metronidazole	Metronidazole	H.J. Harkins Company, Inc.	ANDA	Current
53002-2478	Metronidazole	Metronidazole	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-2478	Metronidazole	Metronidazole	RPK Pharmaceuticals, Inc.	ANDA	Current
55289-521	Metronidazole	Metronidazole	PD-Rx Pharmaceuticals, In	ANDA	Current
55289-521	Metronidazole	Metronidazole	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-521	Metronidazole	Metronidazole	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-521	Metronidazole	Metronidazole	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-521	Metronidazole	Metronidazole	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
60760-334	METRONIDAZOLE	METRONIDAZOLE	St Marys Medical Park Pharmacy	ANDA	Current
63187-035	Metronidazole	Metronidazole	Proficient Rx LP	ANDA	Current
63187-035	Metronidazole	Metronidazole	Proficient Rx LP	ANDA	Current
63187-035	Metronidazole	Metronidazole	Proficient Rx LP	ANDA	Current
63187-035	Metronidazole	Metronidazole	Proficient Rx LP	ANDA	Current
63187-035	Metronidazole	Metronidazole	Proficient Rx LP	ANDA	Current
63629-1386	Metronidazole	Metronidazole	Bryant Ranch Prepack	ANDA	Current
63629-1386	Metronidazole	Metronidazole	Bryant Ranch Prepack	ANDA	Current
63629-1386	Metronidazole	Metronidazole	Bryant Ranch Prepack	ANDA	Current
63629-1386	Metronidazole	Metronidazole	Bryant Ranch Prepack	ANDA	Current
63629-6379	Metronidazole	Metronidazole	Bryant Ranch Prepack	ANDA	Current
63629-6379	Metronidazole	Metronidazole	Bryant Ranch Prepack	ANDA	Current
66116-601	Metronidazole	Metronidazole	MedVantx, Inc.	ANDA	Current
68071-5042	Metronidazole	Metronidazole	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5042	Metronidazole	Metronidazole	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-9083	Metronidazole	Metronidazole	Preferred Pharmaceuticals, Inc.	ANDA	Current
70518-1240	Metronidazole	Metronidazole	REMEDYREPACK INC.	ANDA	Current
70518-1240	Metronidazole	Metronidazole	REMEDYREPACK INC.	ANDA	Current
70518-1241	Metronidazole	Metronidazole	REMEDYREPACK INC.	ANDA	Current
70518-1241	Metronidazole	Metronidazole	REMEDYREPACK INC.	ANDA	Current
70518-1241	Metronidazole	Metronidazole	REMEDYREPACK INC.	ANDA	Current
70518-1241	Metronidazole	Metronidazole	REMEDYREPACK INC.	ANDA	Current
70518-1241	Metronidazole	Metronidazole	REMEDYREPACK INC.	ANDA	Current
70518-1241	Metronidazole	Metronidazole	REMEDYREPACK INC.	ANDA	Current
70518-1241	Metronidazole	Metronidazole	REMEDYREPACK INC.	ANDA	Current
70934-436	Metronidazole	Metronidazole	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-436	Metronidazole	Metronidazole	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
76413-134	Metronidazole	Metronidazole	Central Texas Community Health Centers	ANDA	Current