Application 207569

Type: ANDA
Sponsor: GUARDIAN DRUG

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
A207569-001	LORATADINE	LORATADINE	10MG	TABLET / ORAL			2019-03-12

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	A207569-001	LORATADINE	10MG	TABLET / ORAL	2019-03-12	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207569-001	LORATADINE	10MG	TABLET / ORAL	2019-03-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207569-001	LORATADINE	10MG	TABLET / ORAL	2019-03-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207569-001	LORATADINE	10MG	TABLET / ORAL	2019-03-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207569-001	LORATADINE	10MG	TABLET / ORAL	2019-03-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207569-001	LORATADINE	10MG	TABLET / ORAL	2019-03-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207569-001	LORATADINE	10MG	TABLET / ORAL	2019-03-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207569-001	LORATADINE	10MG	TABLET / ORAL	2019-03-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207569-001	LORATADINE	10MG	TABLET / ORAL	2019-03-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207569-001	LORATADINE	10MG	TABLET / ORAL	2019-03-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207569-001	LORATADINE	10MG	TABLET / ORAL	2019-03-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207569-001	LORATADINE	10MG	TABLET / ORAL	2019-03-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207569-001	LORATADINE	10MG	TABLET / ORAL	2019-03-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207569-001	LORATADINE	10MG	TABLET / ORAL	2019-03-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207569-001	LORATADINE	10MG	TABLET / ORAL	2019-03-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207569-001	LORATADINE	10MG	TABLET / ORAL	2019-03-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207569-001	LORATADINE	10MG	TABLET / ORAL	2019-03-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207569-001	LORATADINE	10MG	TABLET / ORAL	2019-03-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207569-001	LORATADINE	10MG	TABLET / ORAL	2019-03-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207569-001	LORATADINE	10MG	TABLET / ORAL	2019-03-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207569-001	LORATADINE	10MG	TABLET / ORAL	2019-03-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207569-001	LORATADINE	10MG	TABLET / ORAL	2019-03-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207569-001	LORATADINE	10MG	TABLET / ORAL	2019-03-12	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207569-001	LORATADINE	10MG	TABLET / ORAL	2019-03-12	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207569-001	LORATADINE	10MG	TABLET / ORAL	2019-03-12	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207569-001	LORATADINE	10MG	TABLET / ORAL	2019-03-12	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207569-001	LORATADINE	10MG	TABLET / ORAL	2019-03-12	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207569-001	LORATADINE	10MG	TABLET / ORAL	2019-03-12	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207569-001	LORATADINE	10MG	TABLET / ORAL	2019-03-12	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207569-001	LORATADINE	10MG	TABLET / ORAL	2019-03-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207569-001	LORATADINE	10MG	TABLET / ORAL	2019-03-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207569-001	LORATADINE	10MG	TABLET / ORAL	2019-03-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207569-001	LORATADINE	10MG	TABLET / ORAL	2019-03-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207569-001	LORATADINE	10MG	TABLET / ORAL	2019-03-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207569-001	LORATADINE	10MG	TABLET / ORAL	2019-03-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207569-001	LORATADINE	10MG	TABLET / ORAL	2019-03-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207569-001	LORATADINE	10MG	TABLET / ORAL	2019-03-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207569-001	LORATADINE	10MG	TABLET / ORAL	2019-03-12	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207569-001	LORATADINE	10MG	TABLET / ORAL	2019-03-12	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207569-001	LORATADINE	10MG	TABLET / ORAL	2019-03-12	`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 10 of 18 · 342 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Allervarx	LORATADINE	Innovus Pharmaceuticals, Inc.	885e81ae-5ea3-4d14-8666-8c2698767014	2024-12-27	Warnings	Name fallback generic name: LORATADINE
LORATADINE	LORATADINE	Bionpharma Inc.	4fa705fb-859e-4046-b153-a8338c50a97d	2024-12-23	Warnings	Name fallback brand name: LORATADINE generic name: LORATADINE
Sunmark childrens loratadine	LORATADINE	Strategic Sourcing Services LLC	ed94cba7-c2c4-4cbe-9021-f554a51d51f2	2024-12-19	Warnings	Name fallback generic name: LORATADINE
Childrens Loratadine	LORATADINE	Strategic Sourcing Services LLC	280739e5-94e5-4d1e-ba65-2b4304cbac97	2024-12-19	Warnings	Name fallback generic name: LORATADINE
Loratadine	LORATADINE	Spirit Pharmaceuticals LLC	af0cdab2-27a4-5f30-e053-2a95a90a5e71	2024-12-13	Warnings	Name fallback brand name: Loratadine generic name: LORATADINE
foster and thrive allergy relief	LORATADINE	Strategic Sourcing Services LLC	aff1ab34-51b0-488c-931e-c95aad226572	2024-12-11	Warnings	Name fallback generic name: LORATADINE
good neighbor pharmacy loratadine	LORATADINE	Amerisource Bergen	9dda0f0b-fbab-47ee-8db8-95bd126fc61c	2024-12-11	Warnings	Name fallback generic name: LORATADINE
Childrens Loratadine Sugar Free	LORATADINE	American Sales Company	6977d7e0-9d01-4f5e-8d55-98dabb719585	2024-12-09	Warnings	Name fallback generic name: LORATADINE
exchange select allergy relief	LORATADINE	Army & Air Force Exchange Service	ea5622d9-4e71-4a1f-9200-6b4cecac1215	2024-12-02	Warnings	Name fallback generic name: LORATADINE
Loratadine	LORATADINE	American Health Packaging	411f3692-99ff-49d7-8594-e6f404f5861f	2024-11-21	Warnings	Name fallback brand name: Loratadine generic name: LORATADINE
Loratadine	LORATADINE	WALGREENS CO.	c9e12155-a699-4fa7-aac8-da7d5ddab4ae	2024-11-19	Warnings	Name fallback brand name: Loratadine generic name: LORATADINE
good neighbor pharmacy childrens loratadine	LORATADINE	Amerisource Bergen	46cdccaf-a6f2-4a49-a2b0-7ba0df17bfa8	2024-11-19	Warnings	Name fallback generic name: LORATADINE
Basic Care Allergy Relief	LORATADINE	Amazon.com Services LLC	76e35b3f-3382-4e14-a25f-5544c75ff7c8	2024-11-05	Warnings	Name fallback generic name: LORATADINE
Loratadine	LORATADINE	Aurohealth LLC	a057241d-a655-4847-9d2d-d45293f45d87	2024-10-23	Warnings	Name fallback brand name: Loratadine generic name: LORATADINE
Loratadine Allergy Relief	LORATADINE	Proficient Rx LP	a6b9a1bf-1013-4a15-b3b2-a226a75a1ffb	2024-10-01	Warnings	Name fallback generic name: LORATADINE
good sense allergy relief	LORATADINE	A-S Medication Solutions	9cc3d50a-81ce-4c9d-9721-209169a332e0	2024-08-21	Warnings	Name fallback generic name: LORATADINE
Allergy Relief	LORATADINE	CHAIN DRUG MARKETING ASSOCIATION, INC.	e0cb8057-4755-482d-84f4-9275f7b85cd0	2024-08-12	Warnings	Name fallback generic name: LORATADINE
allergy relief	LORATADINE	Meijer Distribution Inc	9261a02b-db43-462f-9f06-fb5624070e20	2024-08-06	Warnings	Name fallback generic name: LORATADINE
UP AND UP CHILDRENS ALLERGY	LORATADINE	Target Corporation	a9f6ae02-cf29-4111-99e7-7e6b1ecb88f0	2024-07-31	Warnings	Name fallback generic name: LORATADINE
Childrens Allergy	LORATADINE	CVS Pharmacy	13c40819-24af-48f1-8371-9e32dc5339a1	2024-07-26	Warnings	Name fallback generic name: LORATADINE

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
53041-285	Guardian Loratadine	Loratadine	Guardian Drug Company	ANDA	Current