Application 021512

Type: NDA
Sponsor: PERRIGO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LORATADINE	LORATADINE	TABLET;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
N021512-001	LORATADINE	LORATADINE	10MG	TABLET / ORAL			2004-06-24

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	N021512-001	LORATADINE	10MG	TABLET / ORAL	2004-06-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021512-001	LORATADINE	10MG	TABLET / ORAL	2004-06-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021512-001	LORATADINE	10MG	TABLET / ORAL	2004-06-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021512-001	LORATADINE	10MG	TABLET / ORAL	2004-06-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021512-001	LORATADINE	10MG	TABLET / ORAL	2004-06-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021512-001	LORATADINE	10MG	TABLET / ORAL	2004-06-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021512-001	LORATADINE	10MG	TABLET / ORAL	2004-06-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021512-001	LORATADINE	10MG	TABLET / ORAL	2004-06-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021512-001	LORATADINE	10MG	TABLET / ORAL	2004-06-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021512-001	LORATADINE	10MG	TABLET / ORAL	2004-06-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021512-001	LORATADINE	10MG	TABLET / ORAL	2004-06-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021512-001	LORATADINE	10MG	TABLET / ORAL	2004-06-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021512-001	LORATADINE	10MG	TABLET / ORAL	2004-06-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021512-001	LORATADINE	10MG	TABLET / ORAL	2004-06-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021512-001	LORATADINE	10MG	TABLET / ORAL	2004-06-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021512-001	LORATADINE	10MG	TABLET / ORAL	2004-06-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021512-001	LORATADINE	10MG	TABLET / ORAL	2004-06-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021512-001	LORATADINE	10MG	TABLET / ORAL	2004-06-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021512-001	LORATADINE	10MG	TABLET / ORAL	2004-06-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021512-001	LORATADINE	10MG	TABLET / ORAL	2004-06-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021512-001	LORATADINE	10MG	TABLET / ORAL	2004-06-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021512-001	LORATADINE	10MG	TABLET / ORAL	2004-06-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021512-001	LORATADINE	10MG	TABLET / ORAL	2004-06-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021512-001	LORATADINE	10MG	TABLET / ORAL	2004-06-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021512-001	LORATADINE	10MG	TABLET / ORAL	2004-06-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021512-001	LORATADINE	10MG	TABLET / ORAL	2004-06-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021512-001	LORATADINE	10MG	TABLET / ORAL	2004-06-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021512-001	LORATADINE	10MG	TABLET / ORAL	2004-06-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021512-001	LORATADINE	10MG	TABLET / ORAL	2004-06-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021512-001	LORATADINE	10MG	TABLET / ORAL	2004-06-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021512-001	LORATADINE	10MG	TABLET / ORAL	2004-06-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021512-001	LORATADINE	10MG	TABLET / ORAL	2004-06-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021512-001	LORATADINE	10MG	TABLET / ORAL	2004-06-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021512-001	LORATADINE	10MG	TABLET / ORAL	2004-06-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021512-001	LORATADINE	10MG	TABLET / ORAL	2004-06-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021512-001	LORATADINE	10MG	TABLET / ORAL	2004-06-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021512-001	LORATADINE	10MG	TABLET / ORAL	2004-06-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021512-001	LORATADINE	10MG	TABLET / ORAL	2004-06-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021512-001	LORATADINE	10MG	TABLET / ORAL	2004-06-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021512-001	LORATADINE	10MG	TABLET / ORAL	2004-06-24	`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 15 of 17 · 336 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
signature care allergy relief	LORATADINE	Safeway	0a4b8eef-762e-42cc-84ee-0018a9a3be58	2022-04-04	Warnings	Name fallback generic name: LORATADINE
Loratadine antihistamine	LORATADINE	Proficient Rx LP	e9b87f79-ebed-4677-8e50-00cb4282ee56	2022-04-01	Warnings	Name fallback generic name: LORATADINE
Loratadine	LORATADINE	Rising Pharmaceuticals, Inc	d28128a3-af54-440e-9bd4-0fccf393d18a	2022-03-10	Warnings	Name fallback brand name: Loratadine generic name: LORATADINE
topcare childrens allergy	LORATADINE	Topco Associates LLC	6e175fae-05dd-45c2-b9ab-7d49369a3c05	2022-02-28	Warnings	Name fallback generic name: LORATADINE
Loratadine	LORATADINE	SAFEWAY INC.	1092b8af-25f2-4c25-b3bc-5ffb14e96024	2021-12-21	Warnings	Name fallback brand name: Loratadine generic name: LORATADINE
Loratadine	LORATADINE	CVS Pharmacy	e63f082c-ff50-43ed-ad2c-598b352413e8	2021-12-21	Warnings	Name fallback brand name: Loratadine generic name: LORATADINE
Topcare Allergy Relief	LORATADINE	Topco Associates LLC	32f4e1d1-c830-4752-8251-bcc233bf03f6	2021-11-29	Warnings	Name fallback generic name: LORATADINE
Loratadine	LORATADINE	MARKSANS PHARMA LIMITED	c30907f9-1761-41e5-bd4e-2613e756e1c6	2021-11-15	Warnings	Name fallback brand name: Loratadine generic name: LORATADINE
careone allergy relief	LORATADINE	American Sales Company	fdacfd88-eb85-4a33-9863-c6ff484fea4e	2021-11-15	Warnings	Name fallback generic name: LORATADINE
Childrens Allergy Relief	LORATADINE	H E B	704ee04d-6bdd-4d0a-ba24-2a9fd79a90fb	2021-08-24	Warnings	Name fallback generic name: LORATADINE
Basic Care Childrens Allergy Relief	LORATADINE	Amazon.com Services LLC	e2c83874-aa95-477a-9cfd-cecfd776ba0e	2021-08-12	Warnings	Name fallback generic name: LORATADINE
good sense allergy relief	LORATADINE	L. Perrigo Company	a8f97128-3af8-493d-8e66-a1e07f594131	2021-07-14	Warnings	Name fallback generic name: LORATADINE
Allergy Relief	LORATADINE	DISCOUNT DRUG MART	c29bf35f-1f19-c3c9-e053-2995a90ac1b6	2021-07-12	Warnings	Name fallback generic name: LORATADINE
Loratadine	LORATADINE	Cardinal Health, 110 dba LEADER	db9d2182-6bf1-424a-a144-f2694c47989f	2021-06-23	Warnings	Name fallback brand name: Loratadine generic name: LORATADINE
dg health allergy relief	LORATADINE	Dolgencorp, LLC	c18c40ae-19c8-4699-842a-43a5c4c236d5	2021-06-22	Warnings	Name fallback generic name: LORATADINE
leader childrens allergy relief	LORATADINE	Cardinal Health 110, LLC. dba Leader	20b438e1-f461-48fa-b007-4c02ecb91b68	2021-06-17	Warnings	Name fallback generic name: LORATADINE
Allergy Relief	LORATADINE	HARRIS TEETER	b8f67f52-906e-c7a8-e053-2995a90a5cbd	2021-04-29	Warnings	Name fallback generic name: LORATADINE
Childrens Allergy	LORATADINE	Wal-Mart Stores Inc	9fb3a3a8-8812-4238-b596-291b79085db9	2021-04-15	Warnings	Name fallback generic name: LORATADINE
Loratadine	LORATADINE	KROGER COMPANY	f5fbfb52-197c-437c-8977-23bd7f2ac7bd	2021-04-08	Warnings	Name fallback brand name: Loratadine generic name: LORATADINE
Allergy Relief	LORATADINE	Ohm Laboratories Inc.	de3a7725-5d1b-4195-a9f8-43f92888997c	2021-04-06	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
42197	ORIG	2007-06-04
37109	ORIG	2004-06-25
27981	ORIG	2004-06-25