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 2 of 2 · 30 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
METOLAZONE	METOLAZONE	Alembic Pharmaceuticals Limited	0f189f26-be06-4030-aebc-d0557b6475fb	2024-05-28	Warnings, Adverse reactions	Name fallback brand name: METOLAZONE generic name: METOLAZONE
Metolazone	METOLAZONE	Bryant Ranch Prepack	564eccca-2eba-4b6d-b6ab-1439c4c83906	2024-05-23	Warnings, Adverse reactions	Name fallback brand name: Metolazone generic name: METOLAZONE
METOLAZONE	METOLAZONE	Alembic Pharmaceuticals Inc.	a84dbb37-648e-42d4-8688-ac39599284f0	2024-05-21	Warnings, Adverse reactions	Name fallback brand name: METOLAZONE generic name: METOLAZONE
METOLAZONE	METOLAZONE	A-S Medication Solutions	fc937c08-7bc0-4f97-80c9-e091e97f2f9a	2023-12-27	Warnings, Adverse reactions	Name fallback brand name: METOLAZONE generic name: METOLAZONE
Metolazone	METOLAZONE	Bryant Ranch Prepack	8f8a79d5-5404-46f1-9974-47ae05e855d7	2023-12-11	Warnings, Adverse reactions	Name fallback brand name: Metolazone generic name: METOLAZONE
Metolazone	METOLAZONE	A-S Medication Solutions	c9e51766-8f1d-4258-9f40-1d394e2de04c	2023-11-13	Warnings, Adverse reactions	Name fallback brand name: Metolazone generic name: METOLAZONE
Metolazone	METOLAZONE	Bryant Ranch Prepack	88c93278-7cf6-4f84-bc03-44bfb8b91e37	2023-11-01	Warnings, Adverse reactions	Name fallback brand name: Metolazone generic name: METOLAZONE
Metolazone	METOLAZONE	Mylan Pharmaceuticals Inc.	6639d111-eb21-4997-b964-f5c61bc088f2	2019-10-01	Warnings, Adverse reactions	Name fallback brand name: Metolazone generic name: METOLAZONE
Metolazone	METOLAZONE	Aphena Pharma Solutions - Tennessee, LLC	71f86ee1-9e43-482b-9ad8-ec5d5576f360	2019-06-03	Warnings, Adverse reactions	Name fallback brand name: Metolazone generic name: METOLAZONE
Metolazone	METOLAZONE	Aphena Pharma Solutions - Tennessee, LLC	80500d09-e1c5-450a-9806-f4f13843229d	2017-12-14	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.