Home Applications 208477 Application 208477
Type ANDA
Sponsor AUROBINDO PHARMA LTD Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 LORATADINE LORATADINE TABLET, ORALLY DISINTEGRATING;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 A208477-001 LORATADINE LORATADINE 10MG TABLET, ORALLY DISINTEGRATING / ORAL 2018-04-11
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 Product TE source text RLD / RS Approval date Source SHA-256 2022-10-28 04:53 UTC 2022-10 A208477-001 LORATADINE 10MG TABLET, ORALLY DISINTEGRATING / ORAL 2018-04-11 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A208477-001 LORATADINE 10MG TABLET, ORALLY DISINTEGRATING / ORAL 2018-04-11 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A208477-001 LORATADINE 10MG TABLET, ORALLY DISINTEGRATING / ORAL 2018-04-11 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A208477-001 LORATADINE 10MG TABLET, ORALLY DISINTEGRATING / ORAL 2018-04-11 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 · 15 matching rows.
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 · 41 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0363-4020 CHILDRENS LORATADINE ODT Loratadine WALGREEN CO. ANDA Current 0363-4020 CHILDRENS LORATADINE ODT Loratadine WALGREEN CO. ANDA Current 0363-4020 CHILDRENS LORATADINE ODT Loratadine WALGREEN CO. ANDA Current 0363-9937 Loratadine ODT Loratadine WALGREEN CO. ANDA Current 0363-9937 Loratadine ODT Loratadine WALGREEN CO. ANDA Current 0363-9937 Loratadine ODT Loratadine WALGREEN CO. ANDA Current 0363-9937 Loratadine ODT Loratadine WALGREEN CO. ANDA Current 0536-1367 Loratadine ODT Loratadine Rugby Laboratories ANDA Current 46122-539 Loratadine ODT Loratadine Amerisource Bergen ANDA Current 46122-539 Loratadine ODT Loratadine Amerisource Bergen ANDA Current 46122-539 Loratadine ODT Loratadine Amerisource Bergen ANDA Current 46122-539 Loratadine ODT Loratadine Amerisource Bergen ANDA Current 46122-539 Loratadine ODT Loratadine Amerisource Bergen ANDA Current 49035-806 Loratadine ODT Loratadine Wal-Mart Stores, Inc. ANDA Current 49035-806 Loratadine ODT Loratadine Wal-Mart Stores, Inc. ANDA Current 49035-806 Loratadine ODT Loratadine Wal-Mart Stores, Inc. ANDA Current 49035-806 Loratadine ODT Loratadine Wal-Mart Stores, Inc. ANDA Current 49035-806 Loratadine ODT Loratadine Wal-Mart Stores, Inc. ANDA Current 49035-806 Loratadine ODT Loratadine Wal-Mart Stores, Inc. ANDA Current 53943-035 Loratadine ODT Loratadine DISCOUNT DRUG MART ANDA Current 53943-035 Loratadine ODT Loratadine DISCOUNT DRUG MART ANDA Current 53943-035 Loratadine ODT Loratadine DISCOUNT DRUG MART ANDA Current 58602-744 Loratadine ODT Loratadine Aurohealth LLC ANDA Current 58602-744 Loratadine ODT Loratadine Aurohealth LLC ANDA Current 58602-744 Loratadine ODT Loratadine Aurohealth LLC ANDA Current 58602-821 Loratadine ODT Loratadine Aurohealth LLC ANDA Current 58602-821 Loratadine ODT Loratadine Aurohealth LLC ANDA Current 58602-821 Loratadine ODT Loratadine Aurohealth LLC ANDA Current 58602-830 Loratadine ODT Loratadine Aurohealth LLC ANDA Current 58602-830 Loratadine ODT Loratadine Aurohealth LLC ANDA Current 58602-830 Loratadine ODT Loratadine Aurohealth LLC ANDA Current 58602-881 Loratadine ODT Loratadine Aurohealth LLC ANDA Current 60000-950 Loratadine ODT Loratadine Ahold U.S.A., Inc, ANDA Current 60000-950 Loratadine ODT Loratadine Ahold U.S.A., Inc, ANDA Current 60000-950 Loratadine ODT Loratadine Ahold U.S.A., Inc, ANDA Current 68016-088 Loratadine ODT Loratadine Chain Drug Consortium, LLC ANDA Current 68016-088 Loratadine ODT Loratadine Chain Drug Consortium, LLC ANDA Current 68016-088 Loratadine ODT Loratadine Chain Drug Consortium, LLC ANDA Current 69842-085 Loratadine ODT Loratadine CVS Pharmacy, Inc. ANDA Current 69842-085 Loratadine ODT Loratadine CVS Pharmacy, Inc. ANDA Current 69842-085 Loratadine ODT Loratadine CVS Pharmacy, Inc. ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 72836 SUPPL 2022-12-09