Application 076482

Type: ANDA
Sponsor: ROXANE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	METOLAZONE	METOLAZONE	TABLET; ORAL	10MG	No	No
002	METOLAZONE	METOLAZONE	TABLET;ORAL	10MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A076482-002	METOLAZONE	METOLAZONE	10MG	TABLET / ORAL			2004-04-29

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A076482-002	METOLAZONE	10MG	TABLET / ORAL	2004-04-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076482-002	METOLAZONE	10MG	TABLET / ORAL	2004-04-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076482-002	METOLAZONE	10MG	TABLET / ORAL	2004-04-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076482-002	METOLAZONE	10MG	TABLET / ORAL	2004-04-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076482-002	METOLAZONE	10MG	TABLET / ORAL	2004-04-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076482-002	METOLAZONE	10MG	TABLET / ORAL	2004-04-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076482-002	METOLAZONE	10MG	TABLET / ORAL	2004-04-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076482-002	METOLAZONE	10MG	TABLET / ORAL	2004-04-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076482-002	METOLAZONE	10MG	TABLET / ORAL	2004-04-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076482-002	METOLAZONE	10MG	TABLET / ORAL	2004-04-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076482-002	METOLAZONE	10MG	TABLET / ORAL	2004-04-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076482-002	METOLAZONE	10MG	TABLET / ORAL	2004-04-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076482-002	METOLAZONE	10MG	TABLET / ORAL	2004-04-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076482-002	METOLAZONE	10MG	TABLET / ORAL	2004-04-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076482-002	METOLAZONE	10MG	TABLET / ORAL	2004-04-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076482-002	METOLAZONE	10MG	TABLET / ORAL	2004-04-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076482-002	METOLAZONE	10MG	TABLET / ORAL	2004-04-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076482-002	METOLAZONE	10MG	TABLET / ORAL	2004-04-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076482-002	METOLAZONE	10MG	TABLET / ORAL	2004-04-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076482-002	METOLAZONE	10MG	TABLET / ORAL	2004-04-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076482-002	METOLAZONE	10MG	TABLET / ORAL	2004-04-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076482-002	METOLAZONE	10MG	TABLET / ORAL	2004-04-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076482-002	METOLAZONE	10MG	TABLET / ORAL	2004-04-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076482-002	METOLAZONE	10MG	TABLET / ORAL	2004-04-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076482-002	METOLAZONE	10MG	TABLET / ORAL	2004-04-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076482-002	METOLAZONE	10MG	TABLET / ORAL	2004-04-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076482-002	METOLAZONE	10MG	TABLET / ORAL	2004-04-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076482-002	METOLAZONE	10MG	TABLET / ORAL	2004-04-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076482-002	METOLAZONE	10MG	TABLET / ORAL	2004-04-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076482-002	METOLAZONE	10MG	TABLET / ORAL	2004-04-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076482-002	METOLAZONE	10MG	TABLET / ORAL	2004-04-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076482-002	METOLAZONE	10MG	TABLET / ORAL	2004-04-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076482-002	METOLAZONE	10MG	TABLET / ORAL	2004-04-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076482-002	METOLAZONE	10MG	TABLET / ORAL	2004-04-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076482-002	METOLAZONE	10MG	TABLET / ORAL	2004-04-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076482-002	METOLAZONE	10MG	TABLET / ORAL	2004-04-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076482-002	METOLAZONE	10MG	TABLET / ORAL	2004-04-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076482-002	METOLAZONE	10MG	TABLET / ORAL	2004-04-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076482-002	METOLAZONE	10MG	TABLET / ORAL	2004-04-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076482-002	METOLAZONE	10MG	TABLET / ORAL	2004-04-29	`f41ea6bd6efb…`

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 2 · 30 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Metolazone	METOLAZONE	Safecor Health LLC	efa8795e-2c89-4519-b49f-13146fb9ded1	2026-08-12	Warnings, Adverse reactions	Name fallback brand name: Metolazone generic name: METOLAZONE
Metolazone	METOLAZONE	Bryant Ranch Prepack	27ab833e-b809-4a80-b7fc-b3599f1751d3	2026-07-22	Warnings, Adverse reactions	Name fallback brand name: Metolazone generic name: METOLAZONE
Metolazone	METOLAZONE	Bryant Ranch Prepack	8fef500f-7855-46ed-a51e-412708505a0e	2026-07-22	Warnings, Adverse reactions	Name fallback brand name: Metolazone generic name: METOLAZONE
Metolazone	METOLAZONE	Golden State Medical Supply, Inc.	c67c00c9-2c2c-6223-e053-2995a90a7291	2026-05-28	Warnings, Adverse reactions	Name fallback brand name: Metolazone generic name: METOLAZONE
Metolazone	METOLAZONE	Amici Pharma, Inc	cbfa3d5c-cce9-4afa-b064-06f1e1041eac	2026-04-01	Warnings, Adverse reactions	Name fallback brand name: Metolazone generic name: METOLAZONE
Metolazone	METOLAZONE	Bryant Ranch Prepack	7df08bbb-0ab8-485c-8994-48ecadd096f1	2026-03-17	Warnings, Adverse reactions	Name fallback brand name: Metolazone generic name: METOLAZONE
Metolazone	METOLAZONE	Method Pharmaceuticals, LLC	1a8c38aa-362e-6bcc-e063-6294a90a1e05	2026-02-11	Warnings, Adverse reactions	Name fallback brand name: Metolazone generic name: METOLAZONE
METOLAZONE	METOLAZONE	Advagen Pharma Limited	6a9c8415-e389-7a9a-73de-532cf3f57ac5	2026-01-15	Warnings, Adverse reactions	Name fallback brand name: METOLAZONE generic name: METOLAZONE
Metolazone	METOLAZONE	Unichem Pharmaceuticals (USA), Inc.	c6fe5426-a184-44b8-a555-621d72aa5b9f	2025-12-11	Warnings, Adverse reactions	Name fallback brand name: Metolazone generic name: METOLAZONE
METOLAZONE	METOLAZONE	Aarkish Pharmaceuticals NJ Inc.	51300edb-2b0f-427c-aeed-bc74a12f52ce	2025-12-08	Warnings, Adverse reactions	Name fallback brand name: METOLAZONE generic name: METOLAZONE
METOLAZONE	METOLAZONE	Marlex Pharmaceuticals, Inc.	efa5244a-9cdf-a806-e053-2a95a90a912e	2025-11-21	Warnings, Adverse reactions	Name fallback brand name: METOLAZONE generic name: METOLAZONE
Metolazone	METOLAZONE	Major Pharmaceuticals	89201e19-d0e8-4192-b2a1-150e9d2c104d	2025-11-20	Warnings, Adverse reactions	Name fallback brand name: Metolazone generic name: METOLAZONE
Metolazone	METOLAZONE	Bryant Ranch Prepack	2125b330-eb56-4310-9806-e101eae4576c	2025-10-21	Warnings, Adverse reactions	Name fallback brand name: Metolazone generic name: METOLAZONE
Metolazone	METOLAZONE	Ingenus Pharmaceuticals LLC	1e566c10-4498-4f79-8874-4cc8c4216213	2025-10-08	Warnings, Adverse reactions	Name fallback brand name: Metolazone generic name: METOLAZONE
Metolazone	METOLAZONE	Mylan Institutional Inc.	e5fe856e-7fd6-47fb-87f7-7c1c621f50a0	2025-07-22	Warnings, Adverse reactions	Name fallback brand name: Metolazone generic name: METOLAZONE
Metolazone	METOLAZONE	Bryant Ranch Prepack	3be4e158-e486-44db-9be7-dc72fdc2dbc7	2025-05-12	Warnings, Adverse reactions	Name fallback brand name: Metolazone generic name: METOLAZONE
Metolazone	METOLAZONE	Bryant Ranch Prepack	34f91465-7a97-e543-e063-6294a90a1ac7	2025-05-12	Warnings, Adverse reactions	Name fallback brand name: Metolazone generic name: METOLAZONE
Metolazone	METOLAZONE	Sandoz Inc	0b619826-2567-49d7-8972-b6da5e4467df	2025-03-19	Warnings, Adverse reactions	Name fallback brand name: Metolazone generic name: METOLAZONE
Metolazone	METOLAZONE	Bryant Ranch Prepack	08cb093a-b8ec-40d9-b292-2513b488d14c	2024-12-24	Warnings, Adverse reactions	Name fallback brand name: Metolazone generic name: METOLAZONE
Metolazone	METOLAZONE	American Health Packaging	0bc97c74-533a-40a6-bcaf-5374890c5846	2024-08-12	Warnings, Adverse reactions	Name fallback brand name: Metolazone generic name: METOLAZONE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.