Application 078702

Type: ANDA
Sponsor: MYLAN

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 1.

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	TE codes	Approval date
A078702-001	CANDESARTAN CILEXETIL	CANDESARTAN CILEXETIL	4MG	TABLET / ORAL	AB	2013-05-03
A078702-002	CANDESARTAN CILEXETIL	CANDESARTAN CILEXETIL	8MG	TABLET / ORAL	AB	2013-05-03
A078702-003	CANDESARTAN CILEXETIL	CANDESARTAN CILEXETIL	16MG	TABLET / ORAL	AB	2013-05-03
A078702-004	CANDESARTAN CILEXETIL	CANDESARTAN CILEXETIL	32MG	TABLET / ORAL	AB	2013-05-03

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A078702-001	AB
A078702-002	AB
A078702-003	AB
A078702-004	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 5 · 164 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	A078702-001	CANDESARTAN CILEXETIL	4MG	TABLET / ORAL	AB	2013-05-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078702-002	CANDESARTAN CILEXETIL	8MG	TABLET / ORAL	AB	2013-05-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078702-003	CANDESARTAN CILEXETIL	16MG	TABLET / ORAL	AB	2013-05-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078702-004	CANDESARTAN CILEXETIL	32MG	TABLET / ORAL	AB	2013-05-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078702-001	CANDESARTAN CILEXETIL	4MG	TABLET / ORAL	AB	2013-05-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078702-002	CANDESARTAN CILEXETIL	8MG	TABLET / ORAL	AB	2013-05-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078702-003	CANDESARTAN CILEXETIL	16MG	TABLET / ORAL	AB	2013-05-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078702-004	CANDESARTAN CILEXETIL	32MG	TABLET / ORAL	AB	2013-05-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078702-001	CANDESARTAN CILEXETIL	4MG	TABLET / ORAL	AB	2013-05-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078702-002	CANDESARTAN CILEXETIL	8MG	TABLET / ORAL	AB	2013-05-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078702-003	CANDESARTAN CILEXETIL	16MG	TABLET / ORAL	AB	2013-05-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078702-004	CANDESARTAN CILEXETIL	32MG	TABLET / ORAL	AB	2013-05-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078702-001	CANDESARTAN CILEXETIL	4MG	TABLET / ORAL	AB	2013-05-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078702-002	CANDESARTAN CILEXETIL	8MG	TABLET / ORAL	AB	2013-05-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078702-003	CANDESARTAN CILEXETIL	16MG	TABLET / ORAL	AB	2013-05-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078702-004	CANDESARTAN CILEXETIL	32MG	TABLET / ORAL	AB	2013-05-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078702-001	CANDESARTAN CILEXETIL	4MG	TABLET / ORAL	AB	2013-05-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078702-002	CANDESARTAN CILEXETIL	8MG	TABLET / ORAL	AB	2013-05-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078702-003	CANDESARTAN CILEXETIL	16MG	TABLET / ORAL	AB	2013-05-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078702-004	CANDESARTAN CILEXETIL	32MG	TABLET / ORAL	AB	2013-05-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078702-001	CANDESARTAN CILEXETIL	4MG	TABLET / ORAL	AB	2013-05-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078702-002	CANDESARTAN CILEXETIL	8MG	TABLET / ORAL	AB	2013-05-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078702-003	CANDESARTAN CILEXETIL	16MG	TABLET / ORAL	AB	2013-05-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078702-004	CANDESARTAN CILEXETIL	32MG	TABLET / ORAL	AB	2013-05-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078702-001	CANDESARTAN CILEXETIL	4MG	TABLET / ORAL	AB	2013-05-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078702-002	CANDESARTAN CILEXETIL	8MG	TABLET / ORAL	AB	2013-05-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078702-003	CANDESARTAN CILEXETIL	16MG	TABLET / ORAL	AB	2013-05-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078702-004	CANDESARTAN CILEXETIL	32MG	TABLET / ORAL	AB	2013-05-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078702-001	CANDESARTAN CILEXETIL	4MG	TABLET / ORAL	AB	2013-05-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078702-002	CANDESARTAN CILEXETIL	8MG	TABLET / ORAL	AB	2013-05-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078702-003	CANDESARTAN CILEXETIL	16MG	TABLET / ORAL	AB	2013-05-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078702-004	CANDESARTAN CILEXETIL	32MG	TABLET / ORAL	AB	2013-05-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078702-001	CANDESARTAN CILEXETIL	4MG	TABLET / ORAL	AB	2013-05-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078702-002	CANDESARTAN CILEXETIL	8MG	TABLET / ORAL	AB	2013-05-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078702-003	CANDESARTAN CILEXETIL	16MG	TABLET / ORAL	AB	2013-05-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078702-004	CANDESARTAN CILEXETIL	32MG	TABLET / ORAL	AB	2013-05-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078702-001	CANDESARTAN CILEXETIL	4MG	TABLET / ORAL	AB	2013-05-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078702-002	CANDESARTAN CILEXETIL	8MG	TABLET / ORAL	AB	2013-05-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078702-003	CANDESARTAN CILEXETIL	16MG	TABLET / ORAL	AB	2013-05-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078702-004	CANDESARTAN CILEXETIL	32MG	TABLET / ORAL	AB	2013-05-03	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 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	A078702-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078702-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078702-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078702-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078702-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078702-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078702-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078702-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078702-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078702-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078702-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078702-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078702-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078702-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078702-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078702-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078702-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078702-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078702-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078702-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078702-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078702-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078702-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078702-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078702-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078702-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078702-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078702-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078702-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078702-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078702-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078702-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078702-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078702-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078702-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078702-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078702-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078702-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078702-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078702-004	AB	1	`d06236e962d9…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
candesartan cilexetil	CANDESARTAN CILEXETIL	Mylan Pharmaceuticals Inc.	904b357e-97bf-475e-90a5-f0449f2a428e	2021-05-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078702 application number: ANDA078702 ndc (product): 0378-3224 ndc (product): 0378-3231 ndc (product): 0378-3225 ndc (product): 0378-3232

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 17 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-3224	candesartan cilexetil	candesartan cilexetil	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3224	candesartan cilexetil	candesartan cilexetil	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3224	candesartan cilexetil	candesartan cilexetil	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3225	candesartan cilexetil	candesartan cilexetil	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3225	candesartan cilexetil	candesartan cilexetil	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3225	candesartan cilexetil	candesartan cilexetil	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3231	candesartan cilexetil	candesartan cilexetil	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3231	candesartan cilexetil	candesartan cilexetil	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3231	candesartan cilexetil	candesartan cilexetil	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3232	candesartan cilexetil	candesartan cilexetil	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3232	candesartan cilexetil	candesartan cilexetil	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3232	candesartan cilexetil	candesartan cilexetil	Mylan Pharmaceuticals Inc.	ANDA	Current
0781-5936	Candesartan cilexetil	Candesartan cilexetil	Sandoz Inc	ANDA	Current
0781-5937	Candesartan cilexetil	Candesartan cilexetil	Sandoz Inc	ANDA	Current
0781-5938	Candesartan cilexetil	Candesartan cilexetil	Sandoz Inc	ANDA	Current
0781-5939	Candesartan cilexetil	Candesartan cilexetil	Sandoz Inc	ANDA	Current
68151-3838	Candesartan cilexetil	Candesartan cilexetil	Carilion Materials Management	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
31381	ORIG	2013-05-07