Application 213827

Type: ANDA
Sponsor: INNOGENIX

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	METOLAZONE	METOLAZONE	TABLET;ORAL	2.5MG	No	No
002	METOLAZONE	METOLAZONE	TABLET;ORAL	5MG	No	No
003	METOLAZONE	METOLAZONE	TABLET;ORAL	10MG	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
A213827-001	METOLAZONE	METOLAZONE	2.5MG	TABLET / ORAL	AB	2021-03-30
A213827-002	METOLAZONE	METOLAZONE	5MG	TABLET / ORAL	AB	2021-03-30
A213827-003	METOLAZONE	METOLAZONE	10MG	TABLET / ORAL	AB	2021-03-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A213827-001	AB
A213827-002	AB
A213827-003	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 · 102 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	A213827-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2021-03-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213827-002	METOLAZONE	5MG	TABLET / ORAL	AB	2021-03-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213827-003	METOLAZONE	10MG	TABLET / ORAL	AB	2021-03-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213827-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2021-03-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213827-002	METOLAZONE	5MG	TABLET / ORAL	AB	2021-03-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213827-003	METOLAZONE	10MG	TABLET / ORAL	AB	2021-03-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213827-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2021-03-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213827-002	METOLAZONE	5MG	TABLET / ORAL	AB	2021-03-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213827-003	METOLAZONE	10MG	TABLET / ORAL	AB	2021-03-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213827-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2021-03-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213827-002	METOLAZONE	5MG	TABLET / ORAL	AB	2021-03-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213827-003	METOLAZONE	10MG	TABLET / ORAL	AB	2021-03-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213827-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2021-03-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213827-002	METOLAZONE	5MG	TABLET / ORAL	AB	2021-03-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213827-003	METOLAZONE	10MG	TABLET / ORAL	AB	2021-03-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213827-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2021-03-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213827-002	METOLAZONE	5MG	TABLET / ORAL	AB	2021-03-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213827-003	METOLAZONE	10MG	TABLET / ORAL	AB	2021-03-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213827-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2021-03-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213827-002	METOLAZONE	5MG	TABLET / ORAL	AB	2021-03-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213827-003	METOLAZONE	10MG	TABLET / ORAL	AB	2021-03-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213827-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2021-03-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213827-002	METOLAZONE	5MG	TABLET / ORAL	AB	2021-03-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213827-003	METOLAZONE	10MG	TABLET / ORAL	AB	2021-03-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213827-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2021-03-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213827-002	METOLAZONE	5MG	TABLET / ORAL	AB	2021-03-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213827-003	METOLAZONE	10MG	TABLET / ORAL	AB	2021-03-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213827-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2021-03-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213827-002	METOLAZONE	5MG	TABLET / ORAL	AB	2021-03-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213827-003	METOLAZONE	10MG	TABLET / ORAL	AB	2021-03-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213827-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2021-03-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213827-002	METOLAZONE	5MG	TABLET / ORAL	AB	2021-03-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213827-003	METOLAZONE	10MG	TABLET / ORAL	AB	2021-03-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213827-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2021-03-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213827-002	METOLAZONE	5MG	TABLET / ORAL	AB	2021-03-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213827-003	METOLAZONE	10MG	TABLET / ORAL	AB	2021-03-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213827-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2021-03-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213827-002	METOLAZONE	5MG	TABLET / ORAL	AB	2021-03-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213827-003	METOLAZONE	10MG	TABLET / ORAL	AB	2021-03-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213827-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2021-03-30	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 102 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	A213827-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213827-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213827-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213827-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213827-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213827-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213827-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213827-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213827-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213827-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213827-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213827-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213827-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213827-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213827-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213827-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213827-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213827-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213827-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213827-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213827-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213827-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213827-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213827-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213827-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213827-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213827-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213827-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213827-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213827-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213827-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213827-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213827-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213827-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213827-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213827-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213827-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213827-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213827-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213827-001	AB	1	`8072bd15b7f6…`

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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Metolazone	METOLAZONE	Bryant Ranch Prepack	27ab833e-b809-4a80-b7fc-b3599f1751d3	2026-07-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213827 application number: ANDA213827
Metolazone	METOLAZONE	Bryant Ranch Prepack	8fef500f-7855-46ed-a51e-412708505a0e	2026-07-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213827 application number: ANDA213827
Metolazone	METOLAZONE	Golden State Medical Supply, Inc.	c67c00c9-2c2c-6223-e053-2995a90a7291	2026-05-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213827 application number: ANDA213827 ndc (product): 51407-432 ndc (product): 51407-431 ndc (product): 51407-433
Metolazone	METOLAZONE	Amici Pharma, Inc	cbfa3d5c-cce9-4afa-b064-06f1e1041eac	2026-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213827 application number: ANDA213827 ndc (product): 69292-564 ndc (product): 69292-562 ndc (product): 69292-566
Metolazone	METOLAZONE	Bryant Ranch Prepack	7df08bbb-0ab8-485c-8994-48ecadd096f1	2026-03-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213827 application number: ANDA213827
Metolazone	METOLAZONE	Method Pharmaceuticals, LLC	1a8c38aa-362e-6bcc-e063-6294a90a1e05	2026-02-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213827 application number: ANDA213827
Metolazone	METOLAZONE	Major Pharmaceuticals	8e8bbe58-0845-40d1-9831-82435f01c7be	2025-07-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213827 application number: ANDA213827
Metolazone	METOLAZONE	Bryant Ranch Prepack	3be4e158-e486-44db-9be7-dc72fdc2dbc7	2025-05-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213827 application number: ANDA213827 ndc (product): 71335-1944
Metolazone	METOLAZONE	American Health Packaging	0bc97c74-533a-40a6-bcaf-5374890c5846	2024-08-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213827 application number: ANDA213827 ndc (product): 60687-635 ndc (product): 60687-624
Metolazone	METOLAZONE	A-S Medication Solutions	c9e51766-8f1d-4258-9f40-1d394e2de04c	2023-11-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213827 application number: ANDA213827

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
51407-431	Metolazone	Metolazone	Golden State Medical Supply, Inc.	ANDA	Current
51407-432	Metolazone	Metolazone	Golden State Medical Supply, Inc.	ANDA	Current
51407-433	Metolazone	Metolazone	Golden State Medical Supply, Inc.	ANDA	Current
60687-624	Metolazone	Metolazone	American Health Packaging	ANDA	Current
60687-635	Metolazone	Metolazone	American Health Packaging	ANDA	Current
69292-562	Metolazone	Metolazone	Amici Pharmaceuticals LLC.	ANDA	Current
69292-564	Metolazone	Metolazone	Amici Pharmaceuticals LLC.	ANDA	Current
69292-566	Metolazone	Metolazone	Amici Pharmaceuticals LLC.	ANDA	Current
71335-1944	Metolazone	Metolazone	Bryant Ranch Prepack	ANDA	Current