Application 216216

Type: ANDA
Sponsor: AACE PHARMS

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
A216216-001	METOLAZONE	METOLAZONE	2.5MG	TABLET / ORAL	AB	2022-10-25
A216216-002	METOLAZONE	METOLAZONE	5MG	TABLET / ORAL	AB	2022-10-25
A216216-003	METOLAZONE	METOLAZONE	10MG	TABLET / ORAL	AB	2022-10-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A216216-001	AB
A216216-002	AB
A216216-003	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 2 · 75 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	A216216-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2022-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216216-002	METOLAZONE	5MG	TABLET / ORAL	AB	2022-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216216-003	METOLAZONE	10MG	TABLET / ORAL	AB	2022-10-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216216-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2022-10-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216216-002	METOLAZONE	5MG	TABLET / ORAL	AB	2022-10-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216216-003	METOLAZONE	10MG	TABLET / ORAL	AB	2022-10-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216216-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2022-10-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216216-002	METOLAZONE	5MG	TABLET / ORAL	AB	2022-10-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216216-003	METOLAZONE	10MG	TABLET / ORAL	AB	2022-10-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216216-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2022-10-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216216-002	METOLAZONE	5MG	TABLET / ORAL	AB	2022-10-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216216-003	METOLAZONE	10MG	TABLET / ORAL	AB	2022-10-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216216-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2022-10-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216216-002	METOLAZONE	5MG	TABLET / ORAL	AB	2022-10-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216216-003	METOLAZONE	10MG	TABLET / ORAL	AB	2022-10-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216216-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2022-10-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216216-002	METOLAZONE	5MG	TABLET / ORAL	AB	2022-10-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216216-003	METOLAZONE	10MG	TABLET / ORAL	AB	2022-10-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216216-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2022-10-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216216-002	METOLAZONE	5MG	TABLET / ORAL	AB	2022-10-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216216-003	METOLAZONE	10MG	TABLET / ORAL	AB	2022-10-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216216-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2022-10-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216216-002	METOLAZONE	5MG	TABLET / ORAL	AB	2022-10-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216216-003	METOLAZONE	10MG	TABLET / ORAL	AB	2022-10-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216216-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2022-10-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216216-002	METOLAZONE	5MG	TABLET / ORAL	AB	2022-10-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216216-003	METOLAZONE	10MG	TABLET / ORAL	AB	2022-10-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216216-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2022-10-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216216-002	METOLAZONE	5MG	TABLET / ORAL	AB	2022-10-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216216-003	METOLAZONE	10MG	TABLET / ORAL	AB	2022-10-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216216-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2022-10-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216216-002	METOLAZONE	5MG	TABLET / ORAL	AB	2022-10-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216216-003	METOLAZONE	10MG	TABLET / ORAL	AB	2022-10-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216216-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2022-10-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216216-002	METOLAZONE	5MG	TABLET / ORAL	AB	2022-10-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216216-003	METOLAZONE	10MG	TABLET / ORAL	AB	2022-10-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216216-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2022-10-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216216-002	METOLAZONE	5MG	TABLET / ORAL	AB	2022-10-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216216-003	METOLAZONE	10MG	TABLET / ORAL	AB	2022-10-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216216-001	METOLAZONE	2.5MG	TABLET / ORAL	AB	2022-10-25	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 69 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	A216216-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216216-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216216-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216216-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216216-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216216-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216216-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216216-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216216-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216216-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216216-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216216-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216216-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216216-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216216-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216216-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216216-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216216-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216216-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216216-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216216-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216216-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216216-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216216-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216216-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216216-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216216-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216216-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216216-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216216-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216216-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216216-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216216-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216216-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216216-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216216-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216216-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216216-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216216-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216216-001	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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
METOLAZONE	METOLAZONE	Aarkish Pharmaceuticals NJ Inc.	51300edb-2b0f-427c-aeed-bc74a12f52ce	2025-12-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216216 application number: ANDA216216
METOLAZONE	METOLAZONE	Marlex Pharmaceuticals, Inc.	efa5244a-9cdf-a806-e053-2a95a90a912e	2025-11-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216216 application number: ANDA216216 ndc (product): 10135-766 ndc (product): 10135-765 ndc (product): 10135-767

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10135-765	METOLAZONE	metolazone	Marlex Pharmaceuticals, Inc.	ANDA	Current
10135-766	METOLAZONE	metolazone	Marlex Pharmaceuticals, Inc.	ANDA	Current
10135-767	METOLAZONE	metolazone	Marlex Pharmaceuticals, Inc.	ANDA	Current
71406-113	METOLAZONE	metolazone	AACE Pharmaceuticals, Inc.	ANDA	Current
71406-113	METOLAZONE	metolazone	AACE Pharmaceuticals, Inc.	ANDA	Current
71406-114	METOLAZONE	metolazone	AACE Pharmaceuticals, Inc.	ANDA	Current
71406-114	METOLAZONE	metolazone	AACE Pharmaceuticals, Inc.	ANDA	Current
71406-115	METOLAZONE	metolazone	AACE Pharmaceuticals, Inc.	ANDA	Current
71406-115	METOLAZONE	metolazone	AACE Pharmaceuticals, Inc.	ANDA	Current