Application 076154

Type: ANDA
Sponsor: MYLAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LORATADINE	LORATADINE	TABLET;ORAL	10MG	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
A076154-001	LORATADINE	LORATADINE	10MG	TABLET / ORAL			2003-08-20

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 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	A076154-001	LORATADINE	10MG	TABLET / ORAL	2003-08-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076154-001	LORATADINE	10MG	TABLET / ORAL	2003-08-20	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076154-001	LORATADINE	10MG	TABLET / ORAL	2003-08-20	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A076154-001	LORATADINE	10MG	TABLET / ORAL	2003-08-20	`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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Loratadine	LORATADINE	Safecor Health, LLC	14d1ecf5-d694-4ce0-87e4-df27f3f4d909	2026-03-31	Warnings	Exact identifier application applno (ANDA): 076154 application number: ANDA076154
Loratadine	LORATADINE	Mylan Institutional Inc.	1fc9ddd1-393d-4fe2-a9e0-d192df7331db	2025-07-22	Warnings	Exact identifier application applno (ANDA): 076154 application number: ANDA076154 ndc (product): 51079-246
Loratadine	LORATADINE	Mylan Pharmaceuticals Inc.	3b307aea-5a68-4c82-959a-cda4ffbd0a4a	2013-11-15	Warnings	Exact identifier application applno (ANDA): 076154 application number: ANDA076154 ndc (product): 0378-8880

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 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-8880	Loratadine	loratadine	Mylan Pharmaceuticals Inc.	ANDA	Current
51079-246	Loratadine	loratadine	Mylan Institutional Inc.	ANDA	Current
51079-246	Loratadine	loratadine	Mylan Institutional Inc.	ANDA	Current
55154-4375	Loratadine	loratadine	Cardinal Health 107, LLC	ANDA	Current
55154-4375	Loratadine	loratadine	Cardinal Health	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
8871	ORIG	2003-04-11