Application 075565

Type: ANDA
Sponsor: PHARM ASSOC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LORATADINE	LORATADINE	SYRUP;ORAL	1MG/ML	No	No
002	LORATADINE	LORATADINE	SYRUP; ORAL	5MG/5ML	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
A075565-001	LORATADINE	LORATADINE	1MG/ML	SYRUP / ORAL			2004-10-05

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	A075565-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-10-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075565-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-10-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075565-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-10-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075565-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-10-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075565-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-10-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075565-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-10-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075565-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-10-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075565-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-10-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075565-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-10-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075565-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-10-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075565-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-10-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075565-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-10-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075565-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-10-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075565-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-10-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075565-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-10-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075565-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-10-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075565-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-10-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075565-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-10-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075565-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-10-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075565-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-10-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075565-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-10-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075565-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-10-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075565-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-10-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075565-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-10-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075565-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-10-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075565-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-10-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075565-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-10-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075565-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-10-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075565-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-10-05	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075565-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-10-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075565-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-10-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075565-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-10-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075565-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-10-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075565-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-10-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075565-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-10-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075565-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-10-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075565-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-10-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075565-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-10-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075565-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-10-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075565-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-10-05	`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 3 of 18 · 342 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Loratadine 10mg	LORATADINE	BETTER LIVING BRANDS, LLC	46d615dd-45d5-2dfc-e063-6394a90a5d42	2026-04-18	Warnings	Name fallback generic name: LORATADINE
All Day Allergy Relief	LORATADINE	WALMART INC. (see also Equate)	80958503-400c-422a-a641-e1a3d5a9a6a8	2026-04-17	Warnings	Name fallback generic name: LORATADINE
Loratadine	LORATADINE	Camber Consumer Care Inc	4dec6d48-78e0-48a4-9274-25f6cbf26a2c	2026-04-10	Warnings	Name fallback brand name: Loratadine generic name: LORATADINE
Childrens Loratadine	LORATADINE	Sun Pharmaceutical Industries, Inc.	78e11f1c-c8a4-4b2a-b7dc-ae1b2dea26d0	2026-04-08	Warnings	Name fallback generic name: LORATADINE
Loratadine	LORATADINE	NuCare Pharmaceuticals,Inc.	16f00a3a-0777-f70c-e063-6294a90a71c9	2026-04-06	Warnings	Name fallback brand name: Loratadine generic name: LORATADINE
ALLERGY RELIEF 10 mg	LORATADINE	TWIN MED LLC	d943f548-aa0d-4476-e053-2a95a90a7bd4	2026-04-01	Warnings	Name fallback generic name: LORATADINE
ALLERGY RELIEF	LORATADINE	CARDINAL HEALTH 110, LLC. DBA LEADER	052e0ea2-441f-42cc-b62c-f2574f995bff	2026-03-31	Warnings	Name fallback generic name: LORATADINE
Loratadine	LORATADINE	Safecor Health, LLC	14d1ecf5-d694-4ce0-87e4-df27f3f4d909	2026-03-31	Warnings	Name fallback brand name: Loratadine generic name: LORATADINE
LORATADINE	LORATADINE	CVS HEALTH CORP	899800a7-89bc-4a39-88b0-f19d78934daf	2026-03-26	Warnings	Name fallback brand name: LORATADINE generic name: LORATADINE
Loratadine	LORATADINE	CVS Pharmacy, Inc.	3937f769-e8e2-4b32-8338-21b0a74a8697	2026-03-20	Warnings	Name fallback brand name: Loratadine generic name: LORATADINE
Loratadine Allergy Relief	LORATADINE	PD-Rx Pharmaceuticals, Inc.	7127b39d-3686-4249-b720-43c02b4c4654	2026-03-19	Warnings	Name fallback generic name: LORATADINE
Childrens Loratadine Oral	LORATADINE	A-S Medication Solutions	0a42baae-554b-4b93-8780-fe45c42fabc0	2026-03-18	Warnings	Name fallback generic name: LORATADINE
CHILDRENS ALLERGY RELIEF	LORATADINE	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	0e84571d-87b6-4742-ac62-9ed68a115c72	2026-03-17	Warnings	Name fallback generic name: LORATADINE
Loratadine	LORATADINE	NuCare Pharmaceuticals,Inc.	c0e3057d-2dd2-de2b-e053-2995a90a1a1d	2026-03-05	Warnings	Name fallback brand name: Loratadine generic name: LORATADINE
Loratadine antihistamine	LORATADINE	PD-Rx Pharmaceuticals, Inc.	039f144b-891b-4ab0-e063-6394a90aa4c8	2026-02-26	Warnings	Name fallback generic name: LORATADINE
Loratadine antihistamine	LORATADINE	PD-Rx Pharmaceuticals, Inc.	775885f9-0580-4eca-94d8-44fce1dcdccd	2026-02-26	Warnings	Name fallback generic name: LORATADINE
Loratadine	LORATADINE	ATLANTIC BIOLOGICALS CORP.	999a1080-5bbd-4027-b6e7-a90a6941ee27	2026-02-26	Warnings	Name fallback brand name: Loratadine generic name: LORATADINE
Dr Simi All Day Allergy Relief	LORATADINE	Farmacias De Similares TX LLC	3c5b2eaa-24da-3314-e063-6294a90a5b21	2026-02-26	Warnings	Name fallback generic name: LORATADINE
allergy relief	LORATADINE	CVS Pharmacy	0038bc38-c205-4d8d-ab78-1abbcd76829e	2026-02-25	Warnings	Name fallback generic name: LORATADINE
allergy relief	LORATADINE	Kroger Company	745d48f2-504d-4e3d-abf8-768d201cf814	2026-02-24	Warnings	Name fallback generic name: LORATADINE

Reported adverse events (FAERS/openFDA)#

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