Application 076466

Type: ANDA
Sponsor: SANDOZ

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	METOLAZONE	METOLAZONE	TABLET;ORAL	5MG	No	No
002	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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A076466-001	METOLAZONE	METOLAZONE	5MG	TABLET / ORAL	AB	RS	2003-12-19
A076466-002	METOLAZONE	METOLAZONE	10MG	TABLET / ORAL	AB	RS	2003-12-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076466-001	AB
A076466-002	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 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A076466-001	METOLAZONE	5MG	TABLET / ORAL	AB	RS	2003-12-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076466-002	METOLAZONE	10MG	TABLET / ORAL	AB	RS	2003-12-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076466-001	METOLAZONE	5MG	TABLET / ORAL	AB	RS	2003-12-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076466-002	METOLAZONE	10MG	TABLET / ORAL	AB	RS	2003-12-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076466-001	METOLAZONE	5MG	TABLET / ORAL	AB	RS	2003-12-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076466-002	METOLAZONE	10MG	TABLET / ORAL	AB	RS	2003-12-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076466-001	METOLAZONE	5MG	TABLET / ORAL	AB	RS	2003-12-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076466-002	METOLAZONE	10MG	TABLET / ORAL	AB	RS	2003-12-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076466-001	METOLAZONE	5MG	TABLET / ORAL	AB	RS	2003-12-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076466-002	METOLAZONE	10MG	TABLET / ORAL	AB	RS	2003-12-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076466-001	METOLAZONE	5MG	TABLET / ORAL	AB	RS	2003-12-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076466-002	METOLAZONE	10MG	TABLET / ORAL	AB	RS	2003-12-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076466-001	METOLAZONE	5MG	TABLET / ORAL	AB	RS	2003-12-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076466-002	METOLAZONE	10MG	TABLET / ORAL	AB	RS	2003-12-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076466-001	METOLAZONE	5MG	TABLET / ORAL	AB	RS	2003-12-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076466-002	METOLAZONE	10MG	TABLET / ORAL	AB	RS	2003-12-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076466-001	METOLAZONE	5MG	TABLET / ORAL	AB	RS	2003-12-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076466-002	METOLAZONE	10MG	TABLET / ORAL	AB	RS	2003-12-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076466-001	METOLAZONE	5MG	TABLET / ORAL	AB	RS	2003-12-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076466-002	METOLAZONE	10MG	TABLET / ORAL	AB	RS	2003-12-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076466-001	METOLAZONE	5MG	TABLET / ORAL	AB	RS	2003-12-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076466-002	METOLAZONE	10MG	TABLET / ORAL	AB	RS	2003-12-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076466-001	METOLAZONE	5MG	TABLET / ORAL	AB	RS	2003-12-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076466-002	METOLAZONE	10MG	TABLET / ORAL	AB	RS	2003-12-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076466-001	METOLAZONE	5MG	TABLET / ORAL	AB	RS	2003-12-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076466-002	METOLAZONE	10MG	TABLET / ORAL	AB	RS	2003-12-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076466-001	METOLAZONE	5MG	TABLET / ORAL	AB	RS	2003-12-19	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076466-002	METOLAZONE	10MG	TABLET / ORAL	AB	RS	2003-12-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076466-001	METOLAZONE	5MG	TABLET / ORAL	AB	RS	2003-12-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076466-002	METOLAZONE	10MG	TABLET / ORAL	AB	RS	2003-12-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076466-001	METOLAZONE	5MG	TABLET / ORAL	AB	RS	2003-12-19	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076466-002	METOLAZONE	10MG	TABLET / ORAL	AB	RS	2003-12-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076466-001	METOLAZONE	5MG	TABLET / ORAL	AB	RS	2003-12-19	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076466-002	METOLAZONE	10MG	TABLET / ORAL	AB	RS	2003-12-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076466-001	METOLAZONE	5MG	TABLET / ORAL	AB		2003-12-19	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076466-002	METOLAZONE	10MG	TABLET / ORAL	AB		2003-12-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076466-001	METOLAZONE	5MG	TABLET / ORAL	AB	RS	2003-12-19	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076466-002	METOLAZONE	10MG	TABLET / ORAL	AB	RS	2003-12-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076466-001	METOLAZONE	5MG	TABLET / ORAL	AB	RS	2003-12-19	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076466-002	METOLAZONE	10MG	TABLET / ORAL	AB	RS	2003-12-19	`782e0a99824c…`

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	A076466-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076466-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076466-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076466-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076466-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076466-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076466-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076466-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076466-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076466-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076466-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076466-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076466-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076466-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076466-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076466-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076466-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076466-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076466-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076466-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076466-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076466-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076466-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076466-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076466-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076466-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076466-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076466-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076466-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076466-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076466-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076466-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076466-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076466-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076466-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076466-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076466-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076466-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076466-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076466-002	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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Metolazone	METOLAZONE	Bryant Ranch Prepack	2125b330-eb56-4310-9806-e101eae4576c	2025-10-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076466 application number: ANDA076466
Metolazone	METOLAZONE	Sandoz Inc	0b619826-2567-49d7-8972-b6da5e4467df	2025-03-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076466 application number: ANDA076466 ndc (product): 0185-5600 ndc (product): 0185-0055
Metolazone	METOLAZONE	Bryant Ranch Prepack	08cb093a-b8ec-40d9-b292-2513b488d14c	2024-12-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076466 application number: ANDA076466
Metolazone	METOLAZONE	Bryant Ranch Prepack	564eccca-2eba-4b6d-b6ab-1439c4c83906	2024-05-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076466 application number: ANDA076466 ndc (product): 63629-7875
Metolazone	METOLAZONE	Bryant Ranch Prepack	8f8a79d5-5404-46f1-9974-47ae05e855d7	2023-12-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076466 application number: ANDA076466 ndc (product): 63629-8733
Metolazone	METOLAZONE	Aphena Pharma Solutions - Tennessee, LLC	71f86ee1-9e43-482b-9ad8-ec5d5576f360	2019-06-03	Warnings, Adverse reactions	Exact identifier ndc (product): 71610-286

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0185-0055	Metolazone	Metolazone	Eon Labs, Inc.	ANDA	Current
0185-0055	Metolazone	Metolazone	Eon Labs, Inc.	ANDA	Current
0185-5600	Metolazone	Metolazone	Eon Labs, Inc.	ANDA	Current
0185-5600	Metolazone	Metolazone	Eon Labs, Inc.	ANDA	Current
63629-7875	Metolazone	Metolazone	Bryant Ranch Prepack	ANDA	Current
63629-7875	Metolazone	Metolazone	Bryant Ranch Prepack	ANDA	Current
63629-8733	Metolazone	Metolazone	Bryant Ranch Prepack	ANDA	Current
63629-8733	Metolazone	Metolazone	Bryant Ranch Prepack	ANDA	Current
63739-404	Metolazone	Metolazone	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-404	Metolazone	Metolazone	McKesson Corporation	ANDA	Current
71610-286	Metolazone	Metolazone	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
43079	ORIG	2012-10-12