Application 075505

Type: ANDA
Sponsor: TEVA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LORATADINE	LORATADINE	SYRUP;ORAL	1MG/ML	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
A075505-001	LORATADINE	LORATADINE	1MG/ML	SYRUP / ORAL			2003-11-07

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	A075505-001	LORATADINE	1MG/ML	SYRUP / ORAL	2003-11-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075505-001	LORATADINE	1MG/ML	SYRUP / ORAL	2003-11-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075505-001	LORATADINE	1MG/ML	SYRUP / ORAL	2003-11-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075505-001	LORATADINE	1MG/ML	SYRUP / ORAL	2003-11-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075505-001	LORATADINE	1MG/ML	SYRUP / ORAL	2003-11-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075505-001	LORATADINE	1MG/ML	SYRUP / ORAL	2003-11-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075505-001	LORATADINE	1MG/ML	SYRUP / ORAL	2003-11-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075505-001	LORATADINE	1MG/ML	SYRUP / ORAL	2003-11-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075505-001	LORATADINE	1MG/ML	SYRUP / ORAL	2003-11-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075505-001	LORATADINE	1MG/ML	SYRUP / ORAL	2003-11-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075505-001	LORATADINE	1MG/ML	SYRUP / ORAL	2003-11-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075505-001	LORATADINE	1MG/ML	SYRUP / ORAL	2003-11-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075505-001	LORATADINE	1MG/ML	SYRUP / ORAL	2003-11-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075505-001	LORATADINE	1MG/ML	SYRUP / ORAL	2003-11-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075505-001	LORATADINE	1MG/ML	SYRUP / ORAL	2003-11-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075505-001	LORATADINE	1MG/ML	SYRUP / ORAL	2003-11-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075505-001	LORATADINE	1MG/ML	SYRUP / ORAL	2003-11-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075505-001	LORATADINE	1MG/ML	SYRUP / ORAL	2003-11-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075505-001	LORATADINE	1MG/ML	SYRUP / ORAL	2003-11-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075505-001	LORATADINE	1MG/ML	SYRUP / ORAL	2003-11-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075505-001	LORATADINE	1MG/ML	SYRUP / ORAL	2003-11-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075505-001	LORATADINE	1MG/ML	SYRUP / ORAL	2003-11-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075505-001	LORATADINE	1MG/ML	SYRUP / ORAL	2003-11-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075505-001	LORATADINE	1MG/ML	SYRUP / ORAL	2003-11-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075505-001	LORATADINE	1MG/ML	SYRUP / ORAL	2003-11-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075505-001	LORATADINE	1MG/ML	SYRUP / ORAL	2003-11-07	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075505-001	LORATADINE	1MG/ML	SYRUP / ORAL	2003-11-07	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075505-001	LORATADINE	1MG/ML	SYRUP / ORAL	2003-11-07	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075505-001	LORATADINE	1MG/ML	SYRUP / ORAL	2003-11-07	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075505-001	LORATADINE	1MG/ML	SYRUP / ORAL	2003-11-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075505-001	LORATADINE	1MG/ML	SYRUP / ORAL	2003-11-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075505-001	LORATADINE	1MG/ML	SYRUP / ORAL	2003-11-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075505-001	LORATADINE	1MG/ML	SYRUP / ORAL	2003-11-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075505-001	LORATADINE	1MG/ML	SYRUP / ORAL	2003-11-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075505-001	LORATADINE	1MG/ML	SYRUP / ORAL	2003-11-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075505-001	LORATADINE	1MG/ML	SYRUP / ORAL	2003-11-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075505-001	LORATADINE	1MG/ML	SYRUP / ORAL	2003-11-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075505-001	LORATADINE	1MG/ML	SYRUP / ORAL	2003-11-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075505-001	LORATADINE	1MG/ML	SYRUP / ORAL	2003-11-07	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075505-001	LORATADINE	1MG/ML	SYRUP / ORAL	2003-11-07	`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 14 of 17 · 336 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Loratadine	LORATADINE	Chain Drug Consortium, LLC	21199958-ac67-4f72-8a8c-4d7d31fa9da4	2022-11-04	Warnings	Name fallback brand name: Loratadine generic name: LORATADINE
Loratadine ODT	LORATADINE	Chain Drug Consortium, LLC	7674009d-492d-4005-a652-f12b91428c0d	2022-11-04	Warnings	Name fallback generic name: LORATADINE
Loratadine	LORATADINE	McLane Company, Inc.	f988f9fb-463d-4aaa-b83d-54a3b114e570	2022-11-04	Warnings	Name fallback brand name: Loratadine generic name: LORATADINE
Loratadine ODT	LORATADINE	DISCOUNT DRUG MART	b4a11eb4-cff8-4280-9dc9-757d51100354	2022-11-04	Warnings	Name fallback generic name: LORATADINE
Loratadine ODT	LORATADINE	Ahold U.S.A., Inc,	092aec8d-57d5-4487-8e1a-b4b586bee7cf	2022-11-04	Warnings	Name fallback generic name: LORATADINE
Loratadine ODT	LORATADINE	Wal-Mart Stores, Inc.	f399f7ab-ab51-46ff-bce9-3014eb021930	2022-11-04	Warnings	Name fallback generic name: LORATADINE
Loratadine ODT	LORATADINE	Aurohealth LLC	1ba8e521-0b0f-419c-b7c3-fa9586f83f36	2022-11-03	Warnings	Name fallback generic name: LORATADINE
Loratadine ODT	LORATADINE	Aurohealth LLC	9f44382f-c289-402d-bb98-ec5fa80fc25d	2022-11-03	Warnings	Name fallback generic name: LORATADINE
Loratadine ODT	LORATADINE	Aurohealth LLC	8c119b12-f512-4207-b354-7244d1f9963a	2022-11-03	Warnings	Name fallback generic name: LORATADINE
Loratadine	LORATADINE	Aurohealth LLC	839e2e03-9ebb-4a44-b753-fb174bd36115	2022-11-03	Warnings	Name fallback brand name: Loratadine generic name: LORATADINE
basic care allergy relief	LORATADINE	Amazon.com Services LLC	a4a7f024-972b-4a16-9cb8-28954c2a74c6	2022-10-18	Warnings	Name fallback generic name: LORATADINE
dg health allergy relief	LORATADINE	Dolgencorp, LLC	04258018-3d57-46d7-9595-04786da3f51a	2022-10-13	Warnings	Name fallback generic name: LORATADINE
welby childrens allergy relief	LORATADINE	Aldi Inc	402c635d-4116-4767-baa9-e956fed02884	2022-09-26	Warnings	Name fallback generic name: LORATADINE
Loratadine	LORATADINE	Winco Foods, LLC.	2a6cf697-0084-4522-bc89-b3e0f96a598d	2022-08-17	Warnings	Name fallback brand name: Loratadine generic name: LORATADINE
Loratadine	LORATADINE	WALGREENS CO.	71adc5b3-3a91-4a1f-acb3-78922a7d9d5a	2022-08-09	Warnings	Name fallback brand name: Loratadine generic name: LORATADINE
Loratadine ODT	LORATADINE	Aurohealth LLC	a6e04fe7-23d3-47d7-9f18-5c4298fbc28b	2022-06-20	Warnings	Name fallback generic name: LORATADINE
Loratadine	LORATADINE	BluePoint Laboratories	adc506ed-7a7a-facc-e053-2a95a90ae147	2022-06-20	Warnings	Name fallback brand name: Loratadine generic name: LORATADINE
Loratadine	LORATADINE	Aurohealth LLC	c6bfb54a-04d8-41c1-9fa9-5d4bae0a66d1	2022-06-18	Warnings	Name fallback brand name: Loratadine generic name: LORATADINE
Dye-Free Childrens Loratadine	LORATADINE	RITE AID	322d9a03-a908-4858-b25e-6eba2411fa03	2022-06-02	Warnings	Name fallback generic name: LORATADINE
Allergy Relief	LORATADINE	AAA PHARMACEUTICAL, INC.	9c8535e3-6a60-4640-b37e-a2260936d9af	2022-04-21	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
8699	ORIG	2003-12-12