Application 208931

Type: ANDA
Sponsor: AUROBINDO PHARMA 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 44.

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
A208931-001	LORATADINE	LORATADINE	1MG/ML	SYRUP / ORAL			2018-06-29

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 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2022-10-28 04:53 UTC	2022-10	A208931-001	LORATADINE	1MG/ML	SYRUP / ORAL	2018-06-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208931-001	LORATADINE	1MG/ML	SYRUP / ORAL	2018-06-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208931-001	LORATADINE	1MG/ML	SYRUP / ORAL	2018-06-29	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A208931-001	LORATADINE	1MG/ML	SYRUP / ORAL	2018-06-29	`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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Loratadine	LORATADINE ORAL	KROGER COMPANY	b963d83b-584f-c447-e053-2995a90ad973	2026-07-06	Warnings	Exact identifier application applno (ANDA): 208931 application number: ANDA208931 ndc (product): 30142-062
Loratadine	LORATADINE ORAL	BluePoint Laboratories	ab820f80-b5fc-7896-e053-2995a90a4b1c	2025-05-15	Warnings	Exact identifier application applno (ANDA): 208931 application number: ANDA208931 ndc (product): 68001-449
Loratadine	LORATADINE ORAL	Aurohealth LLC	0b86a9fe-db7e-470a-a8fa-d7d4373116ba	2025-01-20	Warnings	Exact identifier application applno (ANDA): 208931 application number: ANDA208931 ndc (product): 58602-423
Loratadine	LORATADINE ORAL	Better Living Brands LLC	f7dc7a3d-6709-d7e7-e053-6394a90acde8	2023-09-26	Warnings	Exact identifier application applno (ANDA): 208931 application number: ANDA208931

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 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
30142-062	Loratadine	Loratadine Oral	KROGER COMPANY	ANDA	Current
30142-062	Loratadine	Loratadine Oral	KROGER COMPANY	ANDA	Current
58602-423	Loratadine	Loratadine Oral	Aurohealth LLC	ANDA	Current
58602-423	Loratadine	Loratadine Oral	Aurohealth LLC	ANDA	Current
58602-423	Loratadine	Loratadine Oral	Aurohealth LLC	ANDA	Current
58602-423	Loratadine	Loratadine Oral	Aurohealth LLC	ANDA	Current
68001-449	Loratadine	Loratadine Oral	BluePoint Laboratories	ANDA	Current