Application 210302

Type: ANDA
Sponsor: ALEMBIC PHARMS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CANDESARTAN CILEXETIL	CANDESARTAN CILEXETIL	TABLET;ORAL	4MG	No	No
002	CANDESARTAN CILEXETIL	CANDESARTAN CILEXETIL	TABLET;ORAL	8MG	No	No
003	CANDESARTAN CILEXETIL	CANDESARTAN CILEXETIL	TABLET;ORAL	16MG	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
A210302-001	CANDESARTAN CILEXETIL	CANDESARTAN CILEXETIL	4MG	TABLET / ORAL	AB	2018-12-04
A210302-002	CANDESARTAN CILEXETIL	CANDESARTAN CILEXETIL	8MG	TABLET / ORAL	AB	2018-12-04
A210302-003	CANDESARTAN CILEXETIL	CANDESARTAN CILEXETIL	16MG	TABLET / ORAL	AB	2018-12-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210302-001	AB
A210302-002	AB
A210302-003	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	A210302-001	CANDESARTAN CILEXETIL	4MG	TABLET / ORAL	AB	2018-12-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210302-002	CANDESARTAN CILEXETIL	8MG	TABLET / ORAL	AB	2018-12-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210302-003	CANDESARTAN CILEXETIL	16MG	TABLET / ORAL	AB	2018-12-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210302-001	CANDESARTAN CILEXETIL	4MG	TABLET / ORAL	AB	2018-12-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210302-002	CANDESARTAN CILEXETIL	8MG	TABLET / ORAL	AB	2018-12-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210302-003	CANDESARTAN CILEXETIL	16MG	TABLET / ORAL	AB	2018-12-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210302-001	CANDESARTAN CILEXETIL	4MG	TABLET / ORAL	AB	2018-12-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210302-002	CANDESARTAN CILEXETIL	8MG	TABLET / ORAL	AB	2018-12-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210302-003	CANDESARTAN CILEXETIL	16MG	TABLET / ORAL	AB	2018-12-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210302-001	CANDESARTAN CILEXETIL	4MG	TABLET / ORAL	AB	2018-12-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210302-002	CANDESARTAN CILEXETIL	8MG	TABLET / ORAL	AB	2018-12-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210302-003	CANDESARTAN CILEXETIL	16MG	TABLET / ORAL	AB	2018-12-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210302-001	CANDESARTAN CILEXETIL	4MG	TABLET / ORAL	AB	2018-12-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210302-002	CANDESARTAN CILEXETIL	8MG	TABLET / ORAL	AB	2018-12-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210302-003	CANDESARTAN CILEXETIL	16MG	TABLET / ORAL	AB	2018-12-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210302-001	CANDESARTAN CILEXETIL	4MG	TABLET / ORAL	AB	2018-12-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210302-002	CANDESARTAN CILEXETIL	8MG	TABLET / ORAL	AB	2018-12-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210302-003	CANDESARTAN CILEXETIL	16MG	TABLET / ORAL	AB	2018-12-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210302-001	CANDESARTAN CILEXETIL	4MG	TABLET / ORAL	AB	2018-12-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210302-002	CANDESARTAN CILEXETIL	8MG	TABLET / ORAL	AB	2018-12-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210302-003	CANDESARTAN CILEXETIL	16MG	TABLET / ORAL	AB	2018-12-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210302-001	CANDESARTAN CILEXETIL	4MG	TABLET / ORAL	AB	2018-12-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210302-002	CANDESARTAN CILEXETIL	8MG	TABLET / ORAL	AB	2018-12-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210302-003	CANDESARTAN CILEXETIL	16MG	TABLET / ORAL	AB	2018-12-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210302-001	CANDESARTAN CILEXETIL	4MG	TABLET / ORAL	AB	2018-12-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210302-002	CANDESARTAN CILEXETIL	8MG	TABLET / ORAL	AB	2018-12-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210302-003	CANDESARTAN CILEXETIL	16MG	TABLET / ORAL	AB	2018-12-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210302-001	CANDESARTAN CILEXETIL	4MG	TABLET / ORAL	AB	2018-12-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210302-002	CANDESARTAN CILEXETIL	8MG	TABLET / ORAL	AB	2018-12-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210302-003	CANDESARTAN CILEXETIL	16MG	TABLET / ORAL	AB	2018-12-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210302-001	CANDESARTAN CILEXETIL	4MG	TABLET / ORAL	AB	2018-12-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210302-002	CANDESARTAN CILEXETIL	8MG	TABLET / ORAL	AB	2018-12-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210302-003	CANDESARTAN CILEXETIL	16MG	TABLET / ORAL	AB	2018-12-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210302-001	CANDESARTAN CILEXETIL	4MG	TABLET / ORAL	AB	2018-12-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210302-002	CANDESARTAN CILEXETIL	8MG	TABLET / ORAL	AB	2018-12-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210302-003	CANDESARTAN CILEXETIL	16MG	TABLET / ORAL	AB	2018-12-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210302-001	CANDESARTAN CILEXETIL	4MG	TABLET / ORAL	AB	2018-12-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210302-002	CANDESARTAN CILEXETIL	8MG	TABLET / ORAL	AB	2018-12-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210302-003	CANDESARTAN CILEXETIL	16MG	TABLET / ORAL	AB	2018-12-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210302-001	CANDESARTAN CILEXETIL	4MG	TABLET / ORAL	AB	2018-12-04	`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	A210302-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210302-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210302-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210302-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210302-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210302-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210302-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210302-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210302-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210302-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210302-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210302-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210302-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210302-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210302-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210302-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210302-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210302-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210302-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210302-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210302-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210302-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210302-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210302-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210302-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210302-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210302-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210302-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210302-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210302-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210302-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210302-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210302-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210302-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210302-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210302-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210302-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210302-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210302-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210302-001	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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CANDESARTAN CILEXETIL	CANDESARTAN CILEXETIL	Bryant Ranch Prepack	9afc130e-a784-49fe-9772-27c492724f08	2023-09-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210302 application number: ANDA210302
CANDESARTAN CILEXETIL	CANDESARTAN CILEXETIL	Alembic Pharmaceuticals Limited	d5b43fa0-6678-4219-99f1-10d273d49baf	2023-01-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210302 application number: ANDA210302 ndc (product): 46708-342 ndc (product): 46708-341 ndc (product): 46708-343
CANDESARTAN CILEXETIL	CANDESARTAN CILEXETIL	Alembic Pharmaceuticals Inc.	8a515af5-bd53-43f1-b40a-aa0f332bc2ab	2021-09-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210302 application number: ANDA210302 ndc (product): 62332-343 ndc (product): 62332-341 ndc (product): 62332-342

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 23 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
46708-341	CANDESARTAN CILEXETIL	CANDESARTAN CILEXETIL	Alembic Pharmaceuticals Limited	ANDA	Current
46708-341	CANDESARTAN CILEXETIL	CANDESARTAN CILEXETIL	Alembic Pharmaceuticals Limited	ANDA	Current
46708-342	CANDESARTAN CILEXETIL	CANDESARTAN CILEXETIL	Alembic Pharmaceuticals Limited	ANDA	Current
46708-342	CANDESARTAN CILEXETIL	CANDESARTAN CILEXETIL	Alembic Pharmaceuticals Limited	ANDA	Current
46708-343	CANDESARTAN CILEXETIL	CANDESARTAN CILEXETIL	Alembic Pharmaceuticals Limited	ANDA	Current
46708-343	CANDESARTAN CILEXETIL	CANDESARTAN CILEXETIL	Alembic Pharmaceuticals Limited	ANDA	Current
62332-341	CANDESARTAN CILEXETIL	CANDESARTAN CILEXETIL	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-341	CANDESARTAN CILEXETIL	CANDESARTAN CILEXETIL	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-341	CANDESARTAN CILEXETIL	CANDESARTAN CILEXETIL	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-341	CANDESARTAN CILEXETIL	CANDESARTAN CILEXETIL	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-342	CANDESARTAN CILEXETIL	CANDESARTAN CILEXETIL	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-342	CANDESARTAN CILEXETIL	CANDESARTAN CILEXETIL	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-342	CANDESARTAN CILEXETIL	CANDESARTAN CILEXETIL	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-342	CANDESARTAN CILEXETIL	CANDESARTAN CILEXETIL	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-343	CANDESARTAN CILEXETIL	CANDESARTAN CILEXETIL	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-343	CANDESARTAN CILEXETIL	CANDESARTAN CILEXETIL	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-343	CANDESARTAN CILEXETIL	CANDESARTAN CILEXETIL	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-343	CANDESARTAN CILEXETIL	CANDESARTAN CILEXETIL	Alembic Pharmaceuticals Inc.	ANDA	Current
70518-2719	CANDESARTAN CILEXETIL	CANDESARTAN CILEXETIL	REMEDYREPACK INC.	ANDA	Current
70518-2719	CANDESARTAN CILEXETIL	CANDESARTAN CILEXETIL	REMEDYREPACK INC.	ANDA	Current
70518-2719	CANDESARTAN CILEXETIL	CANDESARTAN CILEXETIL	REMEDYREPACK INC.	ANDA	Current
70518-2884	CANDESARTAN CILEXETIL	CANDESARTAN CILEXETIL	REMEDYREPACK INC.	ANDA	Current
70518-2884	CANDESARTAN CILEXETIL	CANDESARTAN CILEXETIL	REMEDYREPACK INC.	ANDA	Current