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 4 of 18 · 342 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Alavert Allergy	LORATADINE	Foundation Consumer Brands	039ea563-9796-4270-b84a-50dd25a9d976	2026-02-23	Warnings	Name fallback generic name: LORATADINE
Alavert Allergy	LORATADINE	Foundation Consumer Brands	f741d1cf-0ecb-4405-8596-07af394537db	2026-02-23	Warnings	Name fallback generic name: LORATADINE
Loratadine Allergy Relief	LORATADINE	A-S Medication Solutions	a53e5635-8633-4c28-b04f-cdfb3d851e68	2026-02-19	Warnings	Name fallback generic name: LORATADINE
Berkley and Jensen Allergy Relief	LORATADINE	BJWC	e981a0ef-08e9-4ac3-92a1-411217e0a251	2026-02-16	Warnings	Name fallback generic name: LORATADINE
Loratadine	LORATADINE	Major Pharmaceuticals	60162446-4fa1-4ee3-ae20-19fadc2491ab	2026-02-09	Warnings	Name fallback brand name: Loratadine generic name: LORATADINE
Childrens Loratadine Oral	LORATADINE	Atlantic Biologicals	4a1a6981-133c-d45b-e063-6294a90a4a09	2026-02-05	Warnings	Name fallback generic name: LORATADINE
Allergy Relief	LORATADINE	Kroger Company	dac0b200-6b02-4c8a-b1dd-a4d5341dfb2d	2026-02-05	Warnings	Name fallback generic name: LORATADINE
Loratadine	LORATADINE	Strategic Sourcing Services, LLC	a527f83a-4ae9-47b1-94e0-7ab3148b025f	2026-01-29	Warnings	Name fallback brand name: Loratadine generic name: LORATADINE
Allergy Relief	LORATADINE	HyVee Inc	b6ee2b7f-8e01-4962-b28f-91e5cac85276	2026-01-28	Warnings	Name fallback generic name: LORATADINE
Childrens Loratadine Sugar Free	LORATADINE	Preferred Pharmaceuticals Inc.	23936948-71bf-4c18-9160-22b7075e675d	2026-01-15	Warnings	Name fallback generic name: LORATADINE
Childrens Loratadine Sugar Free	LORATADINE	Walgreen Company	42a73448-104a-4c7f-aea0-cef44d15f5f1	2026-01-13	Warnings	Name fallback generic name: LORATADINE
LORATADINE	LORATADINE	Advagen Pharma Limited	a5699a95-c0a7-43ea-9bab-bbfaba3c8aa5	2026-01-05		Name fallback brand name: LORATADINE generic name: LORATADINE
LORATADINE	LORATADINE	KROGER COMPANY	0599cc64-419d-452f-ac50-ac0311006729	2025-12-29	Warnings	Name fallback brand name: LORATADINE generic name: LORATADINE
Claritin	LORATADINE	Select Consumer Group	3c9ad1f8-e8ef-bcd0-e063-6394a90ac20e	2025-12-28	Warnings	Name fallback generic name: LORATADINE
Loratadine	LORATADINE	GRANULES USA, INC.	c3c9bc45-7ed5-abf4-e053-2995a90a40ff	2025-12-22	Warnings	Name fallback brand name: Loratadine generic name: LORATADINE
Loratadine antihistamine	LORATADINE	NCS HealthCare of KY, LLC dba Vangard Labs	f3d05276-21bd-419d-8dba-07ce278d3375	2025-12-22	Warnings	Name fallback generic name: LORATADINE
Loratadine	LORATADINE	Safeway, Inc	f2a2a754-0170-e37c-e053-2a95a90a4dca	2025-12-19	Warnings	Name fallback brand name: Loratadine generic name: LORATADINE
Loratadine	LORATADINE	Walgreens	fd796139-ea9f-f4db-e053-6394a90acdf3	2025-12-19	Warnings	Name fallback brand name: Loratadine generic name: LORATADINE
Allergy Relief	LORATADINE	Valu Merchandisers Company	05927511-6b7a-4e29-96b4-3043493acf11	2025-12-11	Warnings	Name fallback generic name: LORATADINE
Loratadine	LORATADINE	Major Pharmaceuticals	dee25423-377b-4b94-a4a8-0dfb8f51aaab	2025-12-08	Warnings	Name fallback brand name: Loratadine 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