Application 076732

Type: ANDA
Sponsor: SANDOZ

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	METOLAZONE	METOLAZONE	TABLET;ORAL	2.5MG	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
A076732-001	METOLAZONE	METOLAZONE	2.5MG	TABLET / ORAL	AB		2003-12-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076732-001	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	A076732-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2003-12-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076732-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2003-12-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076732-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2003-12-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076732-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2003-12-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076732-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2003-12-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076732-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2003-12-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076732-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2003-12-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076732-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2003-12-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076732-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2003-12-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076732-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2003-12-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076732-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2003-12-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076732-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2003-12-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076732-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2003-12-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076732-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2003-12-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076732-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2003-12-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076732-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2003-12-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076732-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2003-12-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076732-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2003-12-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076732-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2003-12-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076732-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2003-12-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076732-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2003-12-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076732-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2003-12-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076732-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2003-12-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076732-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2003-12-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076732-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2003-12-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076732-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2003-12-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076732-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2003-12-19	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076732-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2003-12-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076732-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2003-12-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076732-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2003-12-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076732-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2003-12-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076732-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2003-12-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076732-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2003-12-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076732-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2003-12-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076732-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2003-12-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076732-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2003-12-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076732-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2003-12-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076732-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2003-12-19	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076732-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2003-12-19	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076732-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2003-12-19	`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	A076732-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076732-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076732-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076732-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076732-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076732-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076732-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076732-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076732-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076732-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076732-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076732-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076732-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076732-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076732-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076732-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076732-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076732-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076732-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076732-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076732-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076732-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076732-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076732-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076732-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076732-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076732-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076732-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076732-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076732-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076732-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076732-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076732-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076732-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076732-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076732-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076732-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076732-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076732-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076732-001	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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Metolazone	METOLAZONE	Bryant Ranch Prepack	34f91465-7a97-e543-e063-6294a90a1ac7	2025-05-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076732 application number: ANDA076732
Metolazone	METOLAZONE	Sandoz Inc	0b619826-2567-49d7-8972-b6da5e4467df	2025-03-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076732 application number: ANDA076732 ndc (product): 0185-5050
Metolazone	METOLAZONE	Bryant Ranch Prepack	88c93278-7cf6-4f84-bc03-44bfb8b91e37	2023-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076732 application number: ANDA076732 ndc (product): 63629-8722
Metolazone	METOLAZONE	Aphena Pharma Solutions - Tennessee, LLC	71f86ee1-9e43-482b-9ad8-ec5d5576f360	2019-06-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076732 application number: ANDA076732 ndc (product): 71610-285

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0185-5050	Metolazone	Metolazone	Eon Labs, Inc.	ANDA	Current
0185-5050	Metolazone	Metolazone	Eon Labs, Inc.	ANDA	Current
0615-6501	Metolazone	Metolazone	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-6502	Metolazone	Metolazone	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
63629-8722	Metolazone	Metolazone	Bryant Ranch Prepack	ANDA	Current
63629-8722	Metolazone	Metolazone	Bryant Ranch Prepack	ANDA	Current
71610-285	Metolazone	Metolazone	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current