Application 017386

Type: NDA
Sponsor: LANNETT CO INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ZAROXOLYN	METOLAZONE	TABLET;ORAL	2.5MG	Yes	No
002	ZAROXOLYN	METOLAZONE	TABLET;ORAL	5MG	Yes	Yes
003	ZAROXOLYN	METOLAZONE	TABLET;ORAL	10MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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	RLD / RS
N017386-001	ZAROXOLYN	METOLAZONE	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982
N017386-002	ZAROXOLYN	METOLAZONE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982
N017386-003	ZAROXOLYN	METOLAZONE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982

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 4 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N017386-001	ZAROXOLYN	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N017386-002	ZAROXOLYN	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N017386-003	ZAROXOLYN	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N017386-001	ZAROXOLYN	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N017386-002	ZAROXOLYN	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N017386-003	ZAROXOLYN	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N017386-001	ZAROXOLYN	2.5MG	TABLET / ORAL	RLD, Approved before 1982	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N017386-002	ZAROXOLYN	5MG	TABLET / ORAL	RLD, Approved before 1982	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N017386-003	ZAROXOLYN	10MG	TABLET / ORAL	RLD, Approved before 1982	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N017386-001	ZAROXOLYN	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N017386-002	ZAROXOLYN	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N017386-003	ZAROXOLYN	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N017386-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N017386-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N017386-003	AB	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017386-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017386-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017386-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N017386-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N017386-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N017386-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N017386-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N017386-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N017386-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N017386-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N017386-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N017386-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N017386-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N017386-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N017386-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N017386-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N017386-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N017386-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N017386-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N017386-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N017386-003	AB	1	`ea99ee380514…`

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

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 32 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0527-2215	metolazone	metolazone	Lannett Company, Inc.	NDA AUTHORIZED GENERIC	Current
0527-2215	metolazone	metolazone	Lannett Company, Inc.	NDA AUTHORIZED GENERIC	Current
0527-2215	metolazone	metolazone	Lannett Company, Inc.	NDA AUTHORIZED GENERIC	Current
0527-2215	metolazone	metolazone	Lannett Company, Inc.	NDA AUTHORIZED GENERIC	Current
0527-2216	metolazone	metolazone	Lannett Company, Inc.	NDA AUTHORIZED GENERIC	Current
0527-2216	metolazone	metolazone	Lannett Company, Inc.	NDA AUTHORIZED GENERIC	Current
0527-2216	metolazone	metolazone	Lannett Company, Inc.	NDA AUTHORIZED GENERIC	Current
0527-2216	metolazone	metolazone	Lannett Company, Inc.	NDA AUTHORIZED GENERIC	Current
0527-2217	metolazone	metolazone	Lannett Company, Inc.	NDA AUTHORIZED GENERIC	Current
0527-2217	metolazone	metolazone	Lannett Company, Inc.	NDA AUTHORIZED GENERIC	Current
0527-2217	metolazone	metolazone	Lannett Company, Inc.	NDA AUTHORIZED GENERIC	Current
0527-2217	metolazone	metolazone	Lannett Company, Inc.	NDA AUTHORIZED GENERIC	Current
0904-6915	metolazone	metolazone	Major Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
0904-6915	metolazone	metolazone	Major Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
0904-6915	metolazone	metolazone	Major Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
0904-6916	metolazone	metolazone	Major Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
0904-6916	metolazone	metolazone	Major Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
43353-999	Metolazone	metolazone	Aphena Pharma Solutions - Tennessee, LLC	NDA AUTHORIZED GENERIC	Current
60687-536	Metolazone	Metolazone	American Health Packaging	NDA AUTHORIZED GENERIC	Current
60687-536	Metolazone	Metolazone	American Health Packaging	NDA AUTHORIZED GENERIC	Current
60687-536	Metolazone	Metolazone	American Health Packaging	NDA AUTHORIZED GENERIC	Current
60687-536	Metolazone	Metolazone	American Health Packaging	NDA AUTHORIZED GENERIC	Current
60687-547	Metolazone	Metolazone	American Health Packaging	NDA AUTHORIZED GENERIC	Current
60687-547	Metolazone	Metolazone	American Health Packaging	NDA AUTHORIZED GENERIC	Current
60687-547	Metolazone	Metolazone	American Health Packaging	NDA AUTHORIZED GENERIC	Current
60687-547	Metolazone	Metolazone	American Health Packaging	NDA AUTHORIZED GENERIC	Current
65580-643	metolazone	metolazone	Upstate Pharma, LLC	NDA AUTHORIZED GENERIC	Current
65580-644	metolazone	metolazone	Upstate Pharma, LLC	NDA AUTHORIZED GENERIC	Current
65580-645	metolazone	metolazone	Upstate Pharma, LLC	NDA AUTHORIZED GENERIC	Current
68151-2943	Zaroxolyn	metolazone	Carilion Materials Management	NDA	Current
71610-142	metolazone	metolazone	Aphena Pharma Solutions - Tennessee, LLC	NDA AUTHORIZED GENERIC	Current
76519-1166	METOLAZONE	METOLAZONE	H.J. Harkins Co., Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
63976	SUPPL	2020-07-21
63894	SUPPL	2020-07-14
50646	SUPPL	2017-12-08
45781	SUPPL	2016-11-02
45780	SUPPL	2016-11-02
13126	SUPPL	2003-08-25
33257	SUPPL	2003-06-16
572	SUPPL	2002-10-29