Application 076698

Type: ANDA
Sponsor: MYLAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	METOLAZONE	METOLAZONE	TABLET;ORAL	2.5MG	No	No
002	METOLAZONE	METOLAZONE	TABLET;ORAL	5MG	No	No
003	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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A076698-001	METOLAZONE	METOLAZONE	2.5MG	TABLET / ORAL	AB	2003-12-23
A076698-002	METOLAZONE	METOLAZONE	5MG	TABLET / ORAL	AB	2004-10-19
A076698-003	METOLAZONE	METOLAZONE	10MG	TABLET / ORAL	AB	2004-10-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A076698-001	AB
A076698-002	AB
A076698-003	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 4 · 123 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	A076698-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2003-12-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076698-002	METOLAZONE	5MG	TABLET / ORAL	AB	2004-10-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076698-003	METOLAZONE	10MG	TABLET / ORAL	AB	2004-10-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076698-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2003-12-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076698-002	METOLAZONE	5MG	TABLET / ORAL	AB	2004-10-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076698-003	METOLAZONE	10MG	TABLET / ORAL	AB	2004-10-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076698-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2003-12-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076698-002	METOLAZONE	5MG	TABLET / ORAL	AB	2004-10-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076698-003	METOLAZONE	10MG	TABLET / ORAL	AB	2004-10-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076698-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2003-12-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076698-002	METOLAZONE	5MG	TABLET / ORAL	AB	2004-10-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076698-003	METOLAZONE	10MG	TABLET / ORAL	AB	2004-10-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076698-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2003-12-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076698-002	METOLAZONE	5MG	TABLET / ORAL	AB	2004-10-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076698-003	METOLAZONE	10MG	TABLET / ORAL	AB	2004-10-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076698-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2003-12-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076698-002	METOLAZONE	5MG	TABLET / ORAL	AB	2004-10-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076698-003	METOLAZONE	10MG	TABLET / ORAL	AB	2004-10-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076698-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2003-12-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076698-002	METOLAZONE	5MG	TABLET / ORAL	AB	2004-10-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076698-003	METOLAZONE	10MG	TABLET / ORAL	AB	2004-10-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076698-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2003-12-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076698-002	METOLAZONE	5MG	TABLET / ORAL	AB	2004-10-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076698-003	METOLAZONE	10MG	TABLET / ORAL	AB	2004-10-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076698-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2003-12-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076698-002	METOLAZONE	5MG	TABLET / ORAL	AB	2004-10-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076698-003	METOLAZONE	10MG	TABLET / ORAL	AB	2004-10-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076698-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2003-12-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076698-002	METOLAZONE	5MG	TABLET / ORAL	AB	2004-10-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076698-003	METOLAZONE	10MG	TABLET / ORAL	AB	2004-10-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076698-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2003-12-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076698-002	METOLAZONE	5MG	TABLET / ORAL	AB	2004-10-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076698-003	METOLAZONE	10MG	TABLET / ORAL	AB	2004-10-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076698-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2003-12-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076698-002	METOLAZONE	5MG	TABLET / ORAL	AB	2004-10-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076698-003	METOLAZONE	10MG	TABLET / ORAL	AB	2004-10-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076698-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2003-12-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076698-002	METOLAZONE	5MG	TABLET / ORAL	AB	2004-10-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076698-003	METOLAZONE	10MG	TABLET / ORAL	AB	2004-10-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076698-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2003-12-23	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	A076698-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076698-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076698-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076698-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076698-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076698-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076698-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076698-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076698-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076698-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076698-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076698-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076698-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076698-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076698-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076698-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076698-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076698-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076698-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076698-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076698-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076698-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076698-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076698-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076698-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076698-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076698-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076698-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076698-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076698-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076698-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076698-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076698-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076698-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076698-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076698-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076698-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076698-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076698-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076698-001	AB	1	`8072bd15b7f6…`

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	Safecor Health LLC	efa8795e-2c89-4519-b49f-13146fb9ded1	2026-03-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076698 application number: ANDA076698
Metolazone	METOLAZONE	Mylan Institutional Inc.	e5fe856e-7fd6-47fb-87f7-7c1c621f50a0	2025-07-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076698 application number: ANDA076698 ndc (product): 51079-023 ndc (product): 51079-024
Metolazone	METOLAZONE	Mylan Pharmaceuticals Inc.	6639d111-eb21-4997-b964-f5c61bc088f2	2019-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076698 application number: ANDA076698 ndc (product): 0378-6172 ndc (product): 0378-6173 ndc (product): 0378-6174
Metolazone	METOLAZONE	Aphena Pharma Solutions - Tennessee, LLC	80500d09-e1c5-450a-9806-f4f13843229d	2017-12-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076698 application number: ANDA076698 ndc (product): 43353-890 ndc (product): 43353-931

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 30 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-6172	Metolazone	metolazone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6172	Metolazone	metolazone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6172	Metolazone	metolazone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6172	Metolazone	metolazone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6172	Metolazone	metolazone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6172	Metolazone	metolazone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6173	Metolazone	metolazone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6173	Metolazone	metolazone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6173	Metolazone	metolazone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6173	Metolazone	metolazone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6173	Metolazone	metolazone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6173	Metolazone	metolazone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6174	Metolazone	metolazone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6174	Metolazone	metolazone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6174	Metolazone	metolazone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6174	Metolazone	metolazone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6174	Metolazone	metolazone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6174	Metolazone	metolazone	Mylan Pharmaceuticals Inc.	ANDA	Current
0615-7691	Metolazone	metolazone	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-7692	Metolazone	metolazone	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
43353-890	Metolazone	metolazone	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
43353-931	Metolazone	metolazone	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
51079-023	Metolazone	metolazone	Mylan Institutional Inc.	ANDA	Current
51079-023	Metolazone	metolazone	Mylan Institutional Inc.	ANDA	Current
51079-023	Metolazone	metolazone	Mylan Institutional Inc.	ANDA	Current
51079-024	Metolazone	metolazone	Mylan Institutional Inc.	ANDA	Current
51079-024	Metolazone	metolazone	Mylan Institutional Inc.	ANDA	Current
51079-024	Metolazone	metolazone	Mylan Institutional Inc.	ANDA	Current
68151-2939	Metolazone	metolazone	Carilion Materials Management	ANDA	Current
68151-2942	Metolazone	metolazone	Carilion Materials Management	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
43097	ORIG	2011-02-15