Application 075822

Type: ANDA
Sponsor: GLAXOSMITHKLINE

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A075822-001	LORATADINE	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL			2003-02-10

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 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A075822-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-02-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075822-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-02-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075822-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-02-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075822-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-02-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075822-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-02-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075822-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-02-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075822-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-02-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075822-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-02-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075822-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-02-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075822-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-02-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075822-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-02-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075822-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-02-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075822-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-02-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075822-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-02-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075822-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-02-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075822-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-02-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075822-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-02-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075822-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-02-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075822-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-02-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075822-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-02-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075822-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-02-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075822-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-02-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075822-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-02-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075822-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-02-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075822-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-02-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075822-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-02-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075822-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-02-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075822-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-02-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075822-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-02-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075822-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-02-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075822-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-02-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075822-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-02-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075822-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-02-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075822-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-02-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075822-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-02-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075822-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-02-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075822-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-02-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075822-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-02-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075822-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-02-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075822-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-02-10	`f41ea6bd6efb…`

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 8 of 18 · 342 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
good sense childrens allergy relief	LORATADINE	L. Perrigo Company	4ce244e2-9fbc-4371-8806-789fd3a61a09	2025-05-06	Warnings	Name fallback generic name: LORATADINE
childrens allergy relief	LORATADINE	Meijer, Inc.	f71d9155-e5fb-4735-86f6-59dd9abf6be0	2025-05-05	Warnings	Name fallback generic name: LORATADINE
equate childrens allergy	LORATADINE	Wal-Mart Stores Inc	5603d5e1-8d95-44b9-aceb-4bc37b162ab1	2025-05-05	Warnings	Name fallback generic name: LORATADINE
Loratadine	LORATADINE	Granules Pharmaceuticals Inc.	d15add22-bc2d-9730-e053-2a95a90acd3f	2025-05-05	Warnings	Name fallback brand name: Loratadine generic name: LORATADINE
Good Sense childrens allergy relief	LORATADINE	L. Perrigo Company	637e309d-9846-45a1-ad11-f67ea85c87b8	2025-05-05	Warnings	Name fallback generic name: LORATADINE
Allergy Relief	LORATADINE	Safeway	8a1b3d40-8ec4-7e76-e053-2a95a90a84b1	2025-04-30	Warnings	Name fallback generic name: LORATADINE
Loratadine	LORATADINE	Bi-Mart	1dd299e7-dfdd-459b-bb2b-83e37dd2e63d	2025-04-11	Warnings	Name fallback brand name: Loratadine generic name: LORATADINE
Allergy Relief	LORATADINE	WinCo Foods, LLC	706a59fa-3d15-4e6e-a38e-ad3f2ef46600	2025-04-08	Warnings	Name fallback generic name: LORATADINE
DYE-FREE CHILDRENS LORATADINE	LORATADINE	WAL-MART STORES, INC	ec24da65-23c1-419d-9603-08348d3b9cc7	2025-04-04	Warnings	Name fallback generic name: LORATADINE
Leader Allergy Relief	LORATADINE	Cardinal Health 110, LLC. dba Leader	6f5134c6-ece6-4e35-a0c3-13e0dfa173fa	2025-04-01	Warnings	Name fallback generic name: LORATADINE
up and up allergy relief	LORATADINE	Target Corporation	c4ef0110-89c3-4ded-9a9a-75c0f794f869	2025-03-28	Warnings	Name fallback generic name: LORATADINE
TopCare Allergy Relief 24 hour	LORATADINE	Topco Associates LLC	a500aebf-a020-4da9-afdb-a699077cb8e1	2025-03-28	Warnings	Name fallback generic name: LORATADINE
CounterAct Allergy	LORATADINE	Melaleuca, Inc.	6b5d43ad-a709-4e0b-b91c-36ea0afe7221	2025-03-17	Warnings	Name fallback generic name: LORATADINE
Loratadine ODT	LORATADINE	CVS Pharmacy, Inc.	37443f0d-bda0-4ddc-a2dd-f3daf495cb40	2025-03-17	Warnings	Name fallback generic name: LORATADINE
dg health allergy relief	LORATADINE	Dolgencorp Inc	086a0a53-7092-4dc8-9c5e-0bd78337fedf	2025-03-11	Warnings	Name fallback generic name: LORATADINE
ValuMeds Allergy Relief	LORATADINE	Cabinet Health P.B.C.	7a67f879-9df9-4536-8fd5-4b9aed05fb47	2025-02-28	Warnings	Name fallback generic name: LORATADINE
Loratadine	LORATADINE	Advanced Rx LLC	e96b4671-82dc-4cc6-a8bf-ef6f1efd8a7d	2025-02-25	Warnings	Name fallback brand name: Loratadine generic name: LORATADINE
Loratadine Allergy Relief	LORATADINE	A-S Medication Solutions	0be70365-57ee-4f2e-a30f-bdd5c292992d	2025-02-20	Warnings	Name fallback generic name: LORATADINE
Loratadine Allergy Relief	LORATADINE	A-S Medication Solutions	baaf9c23-0b54-46a2-8aec-13264479a6d7	2025-02-20	Warnings	Name fallback generic name: LORATADINE
allergy relief	LORATADINE	Meijer, Inc.	14f3d1a2-eda7-432a-8fe0-5437b95bdde6	2025-02-14	Warnings	Name fallback generic name: LORATADINE

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
22506	ORIG	2007-05-09
31030	ORIG	2003-02-10