Application 076529

Type: ANDA
Sponsor: RANBAXY LABS LTD

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
A076529-001	LORATADINE	LORATADINE	1MG/ML	SYRUP / ORAL			2004-08-20

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	A076529-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076529-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076529-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076529-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076529-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076529-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076529-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076529-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076529-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076529-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076529-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076529-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076529-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076529-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076529-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076529-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076529-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076529-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076529-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076529-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076529-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076529-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076529-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076529-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076529-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076529-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076529-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076529-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076529-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076529-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076529-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076529-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076529-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076529-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076529-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076529-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076529-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076529-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076529-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076529-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`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 17 of 18 · 342 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
good sense allergy relief	LORATADINE	L. Perrigo Company	74bed4ad-5afe-4293-bef3-e0b9d5f64a29	2019-12-05	Warnings	Name fallback generic name: LORATADINE
LORATADINE	LORATADINE	PUBLIX SUPER MARKETS INC	8465d458-b3a7-4ada-a7de-1555942d176b	2019-08-07	Warnings	Name fallback brand name: LORATADINE generic name: LORATADINE
Loratadine	LORATADINE	Ohm Laboratories Inc.	b83de07d-37f4-42b4-b43e-29173454bef0	2019-07-17	Warnings	Name fallback brand name: Loratadine generic name: LORATADINE
Loratadine	LORATADINE	KROGER COMPANY	6f7f7005-22db-4b88-9771-e31c21e9b2b1	2019-05-22	Warnings	Name fallback brand name: Loratadine generic name: LORATADINE
CHILDRENS LORATADINE	LORATADINE	CVS PHARMACY, INC	eca96e9e-7e8f-4e8e-8ec6-43c9fee1096c	2019-02-26	Warnings	Name fallback generic name: LORATADINE
Childrens Walitin	LORATADINE	Walgreen Company	f7962107-f79a-4a04-af8d-f7b989e51f2c	2019-01-15	Warnings	Name fallback generic name: LORATADINE
LORATADINE	LORATADINE	Bionpharma Inc.	59bebce3-2b82-4521-a796-2d4c83bcf669	2019-01-08	Warnings	Name fallback brand name: LORATADINE generic name: LORATADINE
Allergy Relief	LORATADINE	Allegiant Health	0991388a-2eb8-4913-9efc-adf411eddf3a	2018-11-08	Warnings	Name fallback generic name: LORATADINE
Loratadine Allergy Relief	LORATADINE	DISCOUNT DRUG MART	55d3ee36-116b-4ec6-b409-79d67a2b54ae	2018-09-14	Warnings	Name fallback generic name: LORATADINE
Loratadine Allergy Relief	LORATADINE	WinCo Foods, LLC	506a60e8-7fec-4bb0-babc-204058ae120f	2018-08-29	Warnings	Name fallback generic name: LORATADINE
Loratadine	LORATADINE	Valu Merchandisers Company	0cd920b4-b15a-4ca9-87e2-4dd523c6d1f8	2018-08-28	Warnings	Name fallback brand name: Loratadine generic name: LORATADINE
Loratadine	LORATADINE	Chain Drug Marketing Association Inc.	b4edf5b1-398d-405a-8a42-76044b31ebb7	2018-08-27	Warnings	Name fallback brand name: Loratadine generic name: LORATADINE
CHILDRENS LORATADINE	LORATADINE	CVS PHARMACY, INC	62e94727-cbb3-4c57-b241-161ab634c680	2018-08-03	Warnings	Name fallback generic name: LORATADINE
LORATADINE	LORATADINE	Rite Aid	11926331-f6b8-4590-9dcd-755a9d946841	2018-06-12	Warnings	Name fallback brand name: LORATADINE generic name: LORATADINE
LORATADINE	LORATADINE	SMART SENSE (KMART)	c2db3398-ead6-4bb6-8aa6-f1366a846144	2018-05-16	Warnings	Name fallback brand name: LORATADINE generic name: LORATADINE
LORATADINE	LORATADINE	TIME CAP LABORATORIES INC	85b26cf3-448c-4d4f-93a2-aa89530ec1f1	2018-05-16	Warnings	Name fallback brand name: LORATADINE generic name: LORATADINE
Loratadine Allergy Relief	LORATADINE	HEB	6703e4f3-e9b8-4c70-9085-3d6ac0d7fbda	2018-05-14	Warnings	Name fallback generic name: LORATADINE
Loratadine	LORATADINE	Premier Value	778a6979-ea47-4381-8c40-84b3c2325a7e	2018-01-11	Warnings	Name fallback brand name: Loratadine generic name: LORATADINE
Loratadine Allergy Relief	LORATADINE	LIDL US, LLC	11bc027c-d28d-45f0-a4cb-24a3834a6995	2018-01-09	Warnings	Name fallback generic name: LORATADINE
Childrens Allergy	LORATADINE	CVS Pharmacy	dc5f58ef-baf0-4de4-9f6d-aedee419b59b	2017-10-02	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
21695-822	Ramipril	ramipril	Rebel Distributors Corp	ANDA	Current