Application 021093

Type: NDA
Sponsor: ANI PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ATACAND HCT	CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE	TABLET;ORAL	16MG;12.5MG	Yes	No
002	ATACAND HCT	CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE	TABLET;ORAL	32MG;12.5MG	Yes	No
003	ATACAND HCT	CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE	TABLET;ORAL	32MG;25MG	Yes	Yes

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	RLD / RS	Approval date
N021093-001	ATACAND HCT	CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE	16MG;12.5MG	TABLET / ORAL	AB	RLD	2000-09-05
N021093-002	ATACAND HCT	CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE	32MG;12.5MG	TABLET / ORAL	AB	RLD	2000-09-05
N021093-003	ATACAND HCT	CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE	32MG;25MG	TABLET / ORAL	AB	RLD, RS	2008-05-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N021093-001	AB
N021093-002	AB
N021093-003	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021093-001	ATACAND HCT	16MG;12.5MG	TABLET / ORAL	AB	RLD	2000-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021093-002	ATACAND HCT	32MG;12.5MG	TABLET / ORAL	AB	RLD	2000-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021093-003	ATACAND HCT	32MG;25MG	TABLET / ORAL	AB	RLD, RS	2008-05-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021093-001	ATACAND HCT	16MG;12.5MG	TABLET / ORAL	AB	RLD	2000-09-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021093-002	ATACAND HCT	32MG;12.5MG	TABLET / ORAL	AB	RLD	2000-09-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021093-003	ATACAND HCT	32MG;25MG	TABLET / ORAL	AB	RLD, RS	2008-05-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021093-001	ATACAND HCT	16MG;12.5MG	TABLET / ORAL	AB	RLD	2000-09-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021093-002	ATACAND HCT	32MG;12.5MG	TABLET / ORAL	AB	RLD	2000-09-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021093-003	ATACAND HCT	32MG;25MG	TABLET / ORAL	AB	RLD, RS	2008-05-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021093-001	ATACAND HCT	16MG;12.5MG	TABLET / ORAL	AB	RLD	2000-09-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021093-002	ATACAND HCT	32MG;12.5MG	TABLET / ORAL	AB	RLD	2000-09-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021093-003	ATACAND HCT	32MG;25MG	TABLET / ORAL	AB	RLD, RS	2008-05-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021093-001	ATACAND HCT	16MG;12.5MG	TABLET / ORAL	AB	RLD	2000-09-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021093-002	ATACAND HCT	32MG;12.5MG	TABLET / ORAL	AB	RLD	2000-09-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021093-003	ATACAND HCT	32MG;25MG	TABLET / ORAL	AB	RLD, RS	2008-05-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021093-001	ATACAND HCT	16MG;12.5MG	TABLET / ORAL	AB	RLD	2000-09-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021093-002	ATACAND HCT	32MG;12.5MG	TABLET / ORAL	AB	RLD	2000-09-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021093-003	ATACAND HCT	32MG;25MG	TABLET / ORAL	AB	RLD, RS	2008-05-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021093-001	ATACAND HCT	16MG;12.5MG	TABLET / ORAL	AB	RLD	2000-09-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021093-002	ATACAND HCT	32MG;12.5MG	TABLET / ORAL	AB	RLD	2000-09-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021093-003	ATACAND HCT	32MG;25MG	TABLET / ORAL	AB	RLD, RS	2008-05-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021093-001	ATACAND HCT	16MG;12.5MG	TABLET / ORAL	AB	RLD	2000-09-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021093-002	ATACAND HCT	32MG;12.5MG	TABLET / ORAL	AB	RLD	2000-09-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021093-003	ATACAND HCT	32MG;25MG	TABLET / ORAL	AB	RLD, RS	2008-05-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021093-001	ATACAND HCT	16MG;12.5MG	TABLET / ORAL	AB	RLD	2000-09-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021093-002	ATACAND HCT	32MG;12.5MG	TABLET / ORAL	AB	RLD	2000-09-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021093-003	ATACAND HCT	32MG;25MG	TABLET / ORAL	AB	RLD, RS	2008-05-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021093-001	ATACAND HCT	16MG;12.5MG	TABLET / ORAL	AB	RLD	2000-09-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021093-002	ATACAND HCT	32MG;12.5MG	TABLET / ORAL	AB	RLD	2000-09-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021093-003	ATACAND HCT	32MG;25MG	TABLET / ORAL	AB	RLD, RS	2008-05-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021093-001	ATACAND HCT	16MG;12.5MG	TABLET / ORAL	AB	RLD	2000-09-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021093-002	ATACAND HCT	32MG;12.5MG	TABLET / ORAL	AB	RLD	2000-09-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021093-003	ATACAND HCT	32MG;25MG	TABLET / ORAL	AB	RLD, RS	2008-05-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021093-001	ATACAND HCT	16MG;12.5MG	TABLET / ORAL	AB	RLD	2000-09-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021093-002	ATACAND HCT	32MG;12.5MG	TABLET / ORAL	AB	RLD	2000-09-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021093-003	ATACAND HCT	32MG;25MG	TABLET / ORAL	AB	RLD, RS	2008-05-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021093-001	ATACAND HCT	16MG;12.5MG	TABLET / ORAL	AB	RLD	2000-09-05	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021093-002	ATACAND HCT	32MG;12.5MG	TABLET / ORAL	AB	RLD	2000-09-05	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021093-003	ATACAND HCT	32MG;25MG	TABLET / ORAL	AB	RLD, RS	2008-05-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021093-001	ATACAND HCT	16MG;12.5MG	TABLET / ORAL	AB	RLD	2000-09-05	`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	N021093-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021093-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021093-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021093-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021093-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021093-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021093-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021093-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021093-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021093-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021093-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021093-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021093-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021093-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021093-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021093-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021093-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021093-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021093-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021093-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021093-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021093-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021093-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021093-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021093-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021093-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021093-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021093-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021093-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021093-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021093-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021093-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021093-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021093-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021093-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021093-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021093-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021093-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021093-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021093-001	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
ATACAND HCT	CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE	ANI Pharmaceuticals, Inc.	d91152c4-66ba-466f-b4f9-0da628d42b1d	2025-12-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021093 application number: NDA021093 ndc (product): 62559-652 ndc (product): 62559-651 ndc (product): 62559-650
Candesartan Cilexetil and Hydrochlorothiazide	CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE	ANI Pharmaceuticals, Inc.	bd8d318d-167a-4b26-935d-265dde3193de	2025-12-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021093 application number: NDA021093 ndc (product): 62559-660 ndc (product): 62559-662 ndc (product): 62559-661

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 26 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0186-0162	ATACAND HCT	Candesartan cilexetil and Hydrochlorothiazide	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-0322	ATACAND HCT	Candesartan cilexetil and Hydrochlorothiazide	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-0324	ATACAND HCT	Candesartan cilexetil Hydrochlorothiazide	AstraZeneca Pharmaceuticals LP	NDA	Current
62559-650	ATACAND HCT	Candesartan Cilexetil and Hydrochlorothiazide	ANI Pharmaceuticals, Inc.	NDA	Current
62559-650	ATACAND HCT	Candesartan Cilexetil and Hydrochlorothiazide	ANI Pharmaceuticals, Inc.	NDA	Current
62559-650	ATACAND HCT	Candesartan Cilexetil and Hydrochlorothiazide	ANI Pharmaceuticals, Inc.	NDA	Current
62559-651	ATACAND HCT	Candesartan Cilexetil and Hydrochlorothiazide	ANI Pharmaceuticals, Inc.	NDA	Current
62559-651	ATACAND HCT	Candesartan Cilexetil and Hydrochlorothiazide	ANI Pharmaceuticals, Inc.	NDA	Current
62559-651	ATACAND HCT	Candesartan Cilexetil and Hydrochlorothiazide	ANI Pharmaceuticals, Inc.	NDA	Current
62559-652	ATACAND HCT	Candesartan Cilexetil and Hydrochlorothiazide	ANI Pharmaceuticals, Inc.	NDA	Current
62559-652	ATACAND HCT	Candesartan Cilexetil and Hydrochlorothiazide	ANI Pharmaceuticals, Inc.	NDA	Current
62559-652	ATACAND HCT	Candesartan Cilexetil and Hydrochlorothiazide	ANI Pharmaceuticals, Inc.	NDA	Current
62559-660	Candesartan Cilexetil and Hydrochlorothiazide	Candesartan Cilexetil and Hydrochlorothiazide	ANI Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
62559-660	Candesartan Cilexetil and Hydrochlorothiazide	Candesartan Cilexetil and Hydrochlorothiazide	ANI Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
62559-660	Candesartan Cilexetil and Hydrochlorothiazide	Candesartan Cilexetil and Hydrochlorothiazide	ANI Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
62559-661	Candesartan Cilexetil and Hydrochlorothiazide	Candesartan Cilexetil and Hydrochlorothiazide	ANI Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
62559-661	Candesartan Cilexetil and Hydrochlorothiazide	Candesartan Cilexetil and Hydrochlorothiazide	ANI Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
62559-661	Candesartan Cilexetil and Hydrochlorothiazide	Candesartan Cilexetil and Hydrochlorothiazide	ANI Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
62559-662	Candesartan Cilexetil and Hydrochlorothiazide	Candesartan Cilexetil and Hydrochlorothiazide	ANI Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
62559-662	Candesartan Cilexetil and Hydrochlorothiazide	Candesartan Cilexetil and Hydrochlorothiazide	ANI Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
62559-662	Candesartan Cilexetil and Hydrochlorothiazide	Candesartan Cilexetil and Hydrochlorothiazide	ANI Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
63629-3377	ATACAND HCT	Candesartan cilexetil and Hydrochlorothiazide	Bryant Ranch Prepack	NDA	Current
63629-3377	ATACAND HCT	Candesartan cilexetil and Hydrochlorothiazide	Bryant Ranch Prepack	NDA	Current
70518-2720	Candesartan Cilexetil and Hydrochlorothiazide	Candesartan Cilexetil and Hydrochlorothiazide	REMEDYREPACK INC.	NDA AUTHORIZED GENERIC	Current
70518-2720	Candesartan Cilexetil and Hydrochlorothiazide	Candesartan Cilexetil and Hydrochlorothiazide	REMEDYREPACK INC.	NDA AUTHORIZED GENERIC	Current
70518-2720	Candesartan Cilexetil and Hydrochlorothiazide	Candesartan Cilexetil and Hydrochlorothiazide	REMEDYREPACK INC.	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
64429	SUPPL	2020-08-27
64381	SUPPL	2020-08-24
14381	SUPPL	2016-03-04
4322	SUPPL	2016-02-11
14380	SUPPL	2015-02-10
4320	SUPPL	2015-02-10
4321	SUPPL	2013-04-30
36107	SUPPL	2013-04-29
4319	SUPPL	2012-04-02
36106	SUPPL	2012-03-29
44096	ORIG	2011-12-22
4318	SUPPL	2011-06-17
36105	SUPPL	2011-06-16
4317	SUPPL	2011-03-16
14379	SUPPL	2011-03-11
26758	SUPPL	2008-05-20
26757	SUPPL	2006-08-18
14378	SUPPL	2006-08-18
4316	SUPPL	2004-12-30
21446	ORIG	2004-05-27
26756	ORIG	2000-09-05
14377	ORIG	2000-09-05