Application 206214

Type: ANDA
Sponsor: MARKSANS PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LORATADINE	LORATADINE	CAPSULE;ORAL	10MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A206214-001	LORATADINE	LORATADINE	10MG	CAPSULE / ORAL			2016-09-23

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`e64feba35796…`

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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ALLERGY RELIEF	LORATADINE	CARDINAL HEALTH 110, LLC. DBA LEADER	052e0ea2-441f-42cc-b62c-f2574f995bff	2026-03-31	Warnings	Exact identifier application applno (ANDA): 206214 application number: ANDA206214
LORATADINE	LORATADINE	CVS HEALTH CORP	899800a7-89bc-4a39-88b0-f19d78934daf	2026-03-26	Warnings	Exact identifier application applno (ANDA): 206214 application number: ANDA206214 ndc (product): 69842-686
LORATADINE	LORATADINE	KROGER COMPANY	0599cc64-419d-452f-ac50-ac0311006729	2025-12-29	Warnings	Exact identifier application applno (ANDA): 206214 application number: ANDA206214 ndc (product): 41226-686
Allergy Relief	LORATADINE	Safeway	8a1b3d40-8ec4-7e76-e053-2a95a90a84b1	2025-04-30	Warnings	Exact identifier application applno (ANDA): 206214 application number: ANDA206214 ndc (product): 21130-195
ALLERGY RELIEF	LORATADINE	TARGET CORPORATION	7cb1364b-0852-3444-e053-2991aa0a3629	2025-02-01	Warnings	Exact identifier application applno (ANDA): 206214 application number: ANDA206214 ndc (product): 11673-986
Allergy Relief	LORATADINE	CHAIN DRUG MARKETING ASSOCIATION, INC.	e0cb8057-4755-482d-84f4-9275f7b85cd0	2024-08-12	Warnings	Exact identifier application applno (ANDA): 206214 application number: ANDA206214
WAL-ITIN	LORATADINE	WALGREENS	9e155aae-4735-4aab-bda9-c21ea29529a4	2022-11-11	Warnings	Exact identifier application applno (ANDA): 206214 application number: ANDA206214 ndc (product): 0363-1686
Loratadine	LORATADINE	MARKSANS PHARMA LIMITED	c30907f9-1761-41e5-bd4e-2613e756e1c6	2021-11-15	Warnings	Exact identifier application applno (ANDA): 206214 application number: ANDA206214 ndc (product): 25000-021
LORATADINE	LORATADINE	SMART SENSE (KMART)	c2db3398-ead6-4bb6-8aa6-f1366a846144	2018-05-16	Warnings	Exact identifier application applno (ANDA): 206214 application number: ANDA206214 ndc (product): 49738-686
LORATADINE	LORATADINE	TIME CAP LABORATORIES INC	85b26cf3-448c-4d4f-93a2-aa89530ec1f1	2018-05-16	Warnings	Exact identifier application applno (ANDA): 206214 application number: ANDA206214 ndc (product): 49483-686

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 24 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0363-1686	WAL-ITIN	LORATADINE	WALGREENS	ANDA	Current
0363-1686	WAL-ITIN	LORATADINE	WALGREENS	ANDA	Current
0363-1686	WAL-ITIN	LORATADINE	WALGREENS	ANDA	Current
11673-986	ALLERGY RELIEF	LORATADINE	TARGET CORPORATION	ANDA	Current
11673-986	ALLERGY RELIEF	LORATADINE	TARGET CORPORATION	ANDA	Current
11673-986	ALLERGY RELIEF	LORATADINE	TARGET CORPORATION	ANDA	Current
11822-0713	Allergy Relief	Loratadine	RITE AID	ANDA	Current
21130-195	Allergy Relief	Loratadine	Safeway	ANDA	Current
25000-021	Loratadine	Loratadine	MARKSANS PHARMA LIMITED	ANDA	Current
25000-021	loratadine	loratadine	MARKSANS PHARMA LIMITED	ANDA	Current
36800-965	Allergy Relief	Loratadine	TopCare	ANDA	Current
36800-965	Allergy Relief	Loratadine	TopCare	ANDA	Current
41226-686	LORATADINE	LORATADINE	KROGER COMPANY	ANDA	Current
49035-686	LORATADINE SOFTGELS	Loratadine	Wal-Mart Stores Inc	ANDA	Current
49483-686	LORATADINE	LORATADINE	TIME CAP LABORATORIES INC	ANDA	Current
49738-686	LORATADINE	LORATADINE	SMART SENSE (KMART)	ANDA	Current
50804-840	Allergy Relief	Loratadine	GOODSENSE	ANDA	Current
50804-840	Allergy Relief	Loratadine	GOODSENSE	ANDA	Current
63868-669	Allergy Relief	loratadine	CHAIN DRUG MARKETING ASSOCIATION INC.	ANDA	Current
68016-055	Allergy Relief	Loratadine	CHAIN DRUG CONSORTIUM	ANDA	Current
69842-686	LORATADINE	LORATADINE	CVS HEALTH CORP	ANDA	Current
69842-686	LORATADINE	LORATADINE	CVS HEALTH CORP	ANDA	Current
69842-686	LORATADINE	LORATADINE	CVS HEALTH CORP	ANDA	Current
70000-0217	LORATADINE	LORATADINE	Cardinal Health	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
45611	ORIG	2016-10-12
45481	ORIG	2016-09-27