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 2 of 18 · 342 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Loratadine	LORATADINE	St. Mary's Medical Park Pharmacy	2bc586e4-5297-44cf-e063-6294a90a531d	2026-06-29	Warnings	Name fallback brand name: Loratadine generic name: LORATADINE
childrens allergy relief	LORATADINE	Kroger Company	52934db1-b6fc-43ca-9a8c-66ff47a94745	2026-06-29	Warnings	Name fallback generic name: LORATADINE
All Day Allergy Relief	LORATADINE	WALMART INC. (see also Equate)	db815af2-4193-4fd9-a028-4a9d54325ca8	2026-06-18	Warnings	Name fallback generic name: LORATADINE
Loratadine	LORATADINE	Cardinal Health 107, LLC	64489b01-a4a7-4c6d-ac84-1dfbd1388d84	2026-06-04	Warnings	Name fallback brand name: Loratadine generic name: LORATADINE
Loratadine	LORATADINE	Preferred Pharmaceuticals Inc.	d778c4d2-184a-4dc8-9351-66d81d0618f2	2026-05-28	Warnings	Name fallback brand name: Loratadine generic name: LORATADINE
Good Sense childrens allergy relief	LORATADINE	Preferred Pharmaceuticals Inc.	27bb0a40-35ee-4c19-bd6f-fb054c8a2586	2026-05-28	Warnings	Name fallback generic name: LORATADINE
Loratadine	LORATADINE	Preferred Pharmaceuticals Inc	0a0d700d-bdba-4c90-a947-5d61d40ce4df	2026-05-28	Warnings	Name fallback brand name: Loratadine generic name: LORATADINE
Loratadine	LORATADINE	Preferred Pharmaceuticals Inc.	c6144a33-6b33-4aca-86e5-a3f688b8b317	2026-05-28	Warnings	Name fallback brand name: Loratadine generic name: LORATADINE
allergy relief	LORATADINE	Rite Aid Corporation	5d58ed7a-e40b-417f-a216-5ec6721d361b	2026-05-27	Warnings	Name fallback generic name: LORATADINE
Allergy Relief	LORATADINE	Grocery Outlet, Inc	441cfa86-a812-f67f-e063-6394a90a2118	2026-05-21	Warnings	Name fallback generic name: LORATADINE
Loratadine	LORATADINE	AvPAK	52581dd2-9597-35cb-e063-6294a90a36c7	2026-05-21	Warnings	Name fallback brand name: Loratadine generic name: LORATADINE
Berkley and Jensen Childrens Allergy Relief	LORATADINE	BJWC	7f9b6a94-2be4-4c96-9a7d-8443f911a4cc	2026-05-21	Warnings	Name fallback generic name: LORATADINE
ValuMeds Allergy Relief Loratadine	LORATADINE	Cabinet Health P.B.C.	43bc8e38-bd74-411c-b4fe-7d809d24ae46	2026-05-20	Warnings	Name fallback generic name: LORATADINE
DYE-FREE LORATADINE	LORATADINE	Ohm Laboratories Inc.	48744daa-7079-283d-e063-6394a90a2c9a	2026-05-05	Warnings	Name fallback generic name: LORATADINE
Loratadine	LORATADINE	KROGER COMPANY	b96831f5-5e75-c526-e053-2995a90a36ad	2026-05-04	Warnings	Name fallback brand name: Loratadine generic name: LORATADINE
CONTAC Allergy	LORATADINE	Vespyr Brands LLC	4587a61d-139e-2a5b-e063-6394a90a1311	2026-05-01	Warnings	Name fallback generic name: LORATADINE
good sense allergy relief	LORATADINE	L. Perrigo Company	80e8a6e8-0c5f-4065-9545-112e146d25ee	2026-04-27	Warnings	Name fallback generic name: LORATADINE
MEDIQUE Loradamed	LORATADINE	Sportpharm LLC	d6bf0e68-f87c-49ee-a15d-df7f5bfa6221	2026-04-24	Warnings	Name fallback generic name: LORATADINE
Loratadine	LORATADINE	Preferred Pharmaceuticals Inc.	7ca5050a-328a-4aff-8954-58f092e3ed6b	2026-04-21	Warnings	Name fallback brand name: Loratadine generic name: LORATADINE
good sense childrens allergy relief	LORATADINE	L. Perrigo Company	643dfe16-9cd1-47bb-8bce-303e6885c644	2026-04-20	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