Application 209794

Type: ANDA
Sponsor: CADILA 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 42.

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
A209794-001	METRONIDAZOLE	METRONIDAZOLE	250MG	TABLET / ORAL	AB		2017-12-12
A209794-002	METRONIDAZOLE	METRONIDAZOLE	500MG	TABLET / ORAL	AB		2017-12-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209794-001	AB
A209794-002	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 · 84 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
2026-08-18 06:07:40	2026-07	A209794-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2017-12-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209794-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2017-12-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209794-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2017-12-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209794-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2017-12-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209794-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2017-12-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209794-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2017-12-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209794-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2017-12-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209794-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2017-12-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209794-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2017-12-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209794-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2017-12-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209794-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2017-12-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209794-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2017-12-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209794-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2017-12-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209794-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2017-12-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209794-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2017-12-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209794-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2017-12-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209794-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2017-12-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209794-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2017-12-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209794-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2017-12-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209794-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2017-12-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209794-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2017-12-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209794-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2017-12-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209794-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2017-12-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209794-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2017-12-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209794-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2017-12-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209794-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2017-12-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209794-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2017-12-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209794-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2017-12-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209794-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2017-12-12	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209794-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2017-12-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209794-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2017-12-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209794-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2017-12-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209794-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2017-12-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209794-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2017-12-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209794-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2017-12-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209794-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2017-12-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209794-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2017-12-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209794-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2017-12-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209794-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2017-12-12	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209794-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2017-12-12	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A209794-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209794-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209794-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209794-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209794-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209794-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209794-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209794-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209794-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209794-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209794-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209794-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209794-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209794-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209794-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209794-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209794-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209794-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209794-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209794-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209794-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209794-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209794-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209794-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209794-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209794-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209794-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209794-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209794-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209794-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209794-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209794-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209794-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209794-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209794-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209794-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209794-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209794-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209794-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209794-002	AB	1	`bb7c543d1eb4…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Metronidazole	METRONIDAZOLE	Bryant Ranch Prepack	5cf3cc1f-601e-4997-bfb2-a573c31c8189	2026-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209794 application number: ANDA209794
Metronidazole	METRONIDAZOLE	Bryant Ranch Prepack	4748ba37-9d66-497d-aa9f-ca2d541c5f41	2026-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209794 application number: ANDA209794
Metronidazole	METRONIDAZOLE	Kanchan Healthcare Inc	8836334e-6db4-44be-bc9e-099b26322cf4	2026-07-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209794 application number: ANDA209794
Metronidazole	METRONIDAZOLE	Cadila Pharmaceuticals Limited	0c55bfc1-770a-4cce-a5dd-446000b24f16	2025-09-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209794 application number: ANDA209794 ndc (product): 71209-062 ndc (product): 71209-063

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
71209-062	Metronidazole	Metronidazole	Cadila Pharmaceuticals Limited	ANDA	Current
71209-062	Metronidazole	Metronidazole	Cadila Pharmaceuticals Limited	ANDA	Current
71209-062	Metronidazole	Metronidazole	Cadila Pharmaceuticals Limited	ANDA	Current
71209-062	Metronidazole	Metronidazole	Cadila Pharmaceuticals Limited	ANDA	Current
71209-063	Metronidazole	Metronidazole	Cadila Pharmaceuticals Limited	ANDA	Current
71209-063	Metronidazole	Metronidazole	Cadila Pharmaceuticals Limited	ANDA	Current
71209-063	Metronidazole	Metronidazole	Cadila Pharmaceuticals Limited	ANDA	Current
71209-063	Metronidazole	Metronidazole	Cadila Pharmaceuticals Limited	ANDA	Current