Application 202079

Type: ANDA
Sponsor: APOTEX INC

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
004	CANDESARTAN CILEXETIL	CANDESARTAN CILEXETIL	TABLET;ORAL	32MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A202079-001	CANDESARTAN CILEXETIL	CANDESARTAN CILEXETIL	4MG	TABLET / ORAL	2014-01-10
A202079-002	CANDESARTAN CILEXETIL	CANDESARTAN CILEXETIL	8MG	TABLET / ORAL	2014-01-10
A202079-003	CANDESARTAN CILEXETIL	CANDESARTAN CILEXETIL	16MG	TABLET / ORAL	2014-01-10
A202079-004	CANDESARTAN CILEXETIL	CANDESARTAN CILEXETIL	32MG	TABLET / ORAL	2014-01-10

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 3 of 5 · 176 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A202079-001	CANDESARTAN CILEXETIL	4MG	TABLET / ORAL	2014-01-10	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202079-002	CANDESARTAN CILEXETIL	8MG	TABLET / ORAL	2014-01-10	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202079-003	CANDESARTAN CILEXETIL	16MG	TABLET / ORAL	2014-01-10	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202079-004	CANDESARTAN CILEXETIL	32MG	TABLET / ORAL	2014-01-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202079-001	CANDESARTAN CILEXETIL	4MG	TABLET / ORAL	2014-01-10	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202079-002	CANDESARTAN CILEXETIL	8MG	TABLET / ORAL	2014-01-10	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202079-003	CANDESARTAN CILEXETIL	16MG	TABLET / ORAL	2014-01-10	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202079-004	CANDESARTAN CILEXETIL	32MG	TABLET / ORAL	2014-01-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202079-001	CANDESARTAN CILEXETIL	4MG	TABLET / ORAL	2014-01-10	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A202079-002	CANDESARTAN CILEXETIL	8MG	TABLET / ORAL	2014-01-10	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A202079-003	CANDESARTAN CILEXETIL	16MG	TABLET / ORAL	2014-01-10	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A202079-004	CANDESARTAN CILEXETIL	32MG	TABLET / ORAL	2014-01-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202079-001	CANDESARTAN CILEXETIL	4MG	TABLET / ORAL	2014-01-10	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202079-002	CANDESARTAN CILEXETIL	8MG	TABLET / ORAL	2014-01-10	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202079-003	CANDESARTAN CILEXETIL	16MG	TABLET / ORAL	2014-01-10	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202079-004	CANDESARTAN CILEXETIL	32MG	TABLET / ORAL	2014-01-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202079-001	CANDESARTAN CILEXETIL	4MG	TABLET / ORAL	2014-01-10	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A202079-002	CANDESARTAN CILEXETIL	8MG	TABLET / ORAL	2014-01-10	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A202079-003	CANDESARTAN CILEXETIL	16MG	TABLET / ORAL	2014-01-10	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A202079-004	CANDESARTAN CILEXETIL	32MG	TABLET / ORAL	2014-01-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202079-001	CANDESARTAN CILEXETIL	4MG	TABLET / ORAL	2014-01-10	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A202079-002	CANDESARTAN CILEXETIL	8MG	TABLET / ORAL	2014-01-10	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A202079-003	CANDESARTAN CILEXETIL	16MG	TABLET / ORAL	2014-01-10	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A202079-004	CANDESARTAN CILEXETIL	32MG	TABLET / ORAL	2014-01-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202079-001	CANDESARTAN CILEXETIL	4MG	TABLET / ORAL	2014-01-10	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A202079-002	CANDESARTAN CILEXETIL	8MG	TABLET / ORAL	2014-01-10	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A202079-003	CANDESARTAN CILEXETIL	16MG	TABLET / ORAL	2014-01-10	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A202079-004	CANDESARTAN CILEXETIL	32MG	TABLET / ORAL	2014-01-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202079-001	CANDESARTAN CILEXETIL	4MG	TABLET / ORAL	2014-01-10	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A202079-002	CANDESARTAN CILEXETIL	8MG	TABLET / ORAL	2014-01-10	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A202079-003	CANDESARTAN CILEXETIL	16MG	TABLET / ORAL	2014-01-10	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A202079-004	CANDESARTAN CILEXETIL	32MG	TABLET / ORAL	2014-01-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202079-001	CANDESARTAN CILEXETIL	4MG	TABLET / ORAL	2014-01-10	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A202079-002	CANDESARTAN CILEXETIL	8MG	TABLET / ORAL	2014-01-10	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A202079-003	CANDESARTAN CILEXETIL	16MG	TABLET / ORAL	2014-01-10	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A202079-004	CANDESARTAN CILEXETIL	32MG	TABLET / ORAL	2014-01-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202079-001	CANDESARTAN CILEXETIL	4MG	TABLET / ORAL	2014-01-10	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A202079-002	CANDESARTAN CILEXETIL	8MG	TABLET / ORAL	2014-01-10	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A202079-003	CANDESARTAN CILEXETIL	16MG	TABLET / ORAL	2014-01-10	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A202079-004	CANDESARTAN CILEXETIL	32MG	TABLET / ORAL	2014-01-10	`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 1 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Candesartan cilexetil	CANDESARTAN CILEXETIL	Viona Pharmaceuticals Inc	9da86c48-5911-4512-8c71-eca4a6418cf6	2026-09-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Candesartan cilexetil generic name: CANDESARTAN CILEXETIL
Candesartan cilexetil	CANDESARTAN CILEXETIL	Golden State Medical Supply, Inc.	15601654-76da-04cf-e063-6394a90a2cb5	2026-01-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Candesartan cilexetil generic name: CANDESARTAN CILEXETIL
Candesartan cilexetil	CANDESARTAN CILEXETIL	Zydus Lifesciences Limited	26df3269-3682-4ce0-be81-8c029254b5a8	2025-12-24		Name fallback brand name: Candesartan cilexetil generic name: CANDESARTAN CILEXETIL
ATACAND	CANDESARTAN CILEXETIL	ANI Pharmaceuticals, Inc.	94a59260-d2b6-464a-b5b9-bbc599e57e10	2025-12-22	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CANDESARTAN CILEXETIL
Candesartan cilexetil	CANDESARTAN CILEXETIL	ANI Pharmaceuticals, Inc.	4621249c-1f44-4d95-8513-a1a2b1859e41	2025-12-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Candesartan cilexetil generic name: CANDESARTAN CILEXETIL
CANDESARTAN CILEXETIL	CANDESARTAN CILEXETIL	Bryant Ranch Prepack	9afc130e-a784-49fe-9772-27c492724f08	2023-09-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: CANDESARTAN CILEXETIL generic name: CANDESARTAN CILEXETIL
CANDESARTAN CILEXETIL	CANDESARTAN CILEXETIL	Alembic Pharmaceuticals Limited	d5b43fa0-6678-4219-99f1-10d273d49baf	2023-01-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: CANDESARTAN CILEXETIL generic name: CANDESARTAN CILEXETIL
CANDESARTAN CILEXETIL	CANDESARTAN CILEXETIL	Alembic Pharmaceuticals Limited	d23fe59a-2ad6-4885-a0d8-2239048f05a3	2023-01-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: CANDESARTAN CILEXETIL generic name: CANDESARTAN CILEXETIL
CANDESARTAN CILEXETIL	CANDESARTAN CILEXETIL	Alembic Pharmaceuticals Inc.	0f2b2fa3-249b-4756-a3f1-3223a004d9cb	2021-10-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: CANDESARTAN CILEXETIL generic name: CANDESARTAN CILEXETIL
CANDESARTAN CILEXETIL	CANDESARTAN CILEXETIL	Alembic Pharmaceuticals Inc.	8a515af5-bd53-43f1-b40a-aa0f332bc2ab	2021-09-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: CANDESARTAN CILEXETIL generic name: CANDESARTAN CILEXETIL
candesartan cilexetil	CANDESARTAN CILEXETIL	Mylan Pharmaceuticals Inc.	904b357e-97bf-475e-90a5-f0449f2a428e	2021-05-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: candesartan cilexetil generic name: CANDESARTAN CILEXETIL

Reported adverse events (FAERS/openFDA)#

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