Application 201865

Type: ANDA
Sponsor: TARO

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
A201865-001	LORATADINE	LORATADINE	1MG/ML	SYRUP / ORAL			2015-07-31

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 2 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
2022-09-29 23:25 UTC	2022-09	A201865-001	LORATADINE	1MG/ML	SYRUP / ORAL	2015-07-31	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A201865-001	LORATADINE	1MG/ML	SYRUP / ORAL	2015-07-31	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A201865-001	LORATADINE	1MG/ML	SYRUP / ORAL	2015-07-31	`a50c72e98297…`

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 1 of 1 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Childrens Loratadine Sugar Free	LORATADINE	Sun Pharmaceutical Industries, Inc.	96a76906-58ad-40cd-be27-4ea254e298c5	2026-07-14	Warnings	Exact identifier application applno (ANDA): 201865 application number: ANDA201865 ndc (product): 51672-2108
Loratadine	LORATADINE	WALGREEN COMPANY	3881afaf-8d0d-4154-85a8-79a3c7806b49	2025-11-17	Warnings	Exact identifier application applno (ANDA): 201865 application number: ANDA201865
Childrens Allergy	LORATADINE	Wal-Mart Stores Inc	9fb3a3a8-8812-4238-b596-291b79085db9	2021-04-15	Warnings	Exact identifier application applno (ANDA): 201865 application number: ANDA201865 ndc (product): 49035-538
Childrens Walitin	LORATADINE	Walgreen Company	f7962107-f79a-4a04-af8d-f7b989e51f2c	2019-01-15	Warnings	Exact identifier application applno (ANDA): 201865 application number: ANDA201865 ndc (product): 0363-2108
Childrens Allergy	LORATADINE	CVS Pharmacy	dc5f58ef-baf0-4de4-9f6d-aedee419b59b	2017-10-02	Warnings	Exact identifier application applno (ANDA): 201865 application number: ANDA201865 ndc (product): 69842-535

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 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0363-2108	Childrens Walitin	Loratadine	Walgreen Company	ANDA	Current
49035-538	Childrens Allergy	Loratadine	Wal-Mart Stores Inc	ANDA	Current
49035-538	Childrens Allergy	Loratadine	Wal-Mart Stores Inc	ANDA	Current
51672-2108	Childrens Loratadine	Loratadine	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-2108	Childrens Loratadine	Loratadine	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
69842-535	Childrens Allergy	Loratadine	CVS Pharmacy	ANDA	Current