Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 078364
Company: SANDOZ
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DESLORATADINE DESLORATADINE 5MG TABLET;ORAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/03/2010 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/22/2019 SUPPL-10 Labeling-Patient Package Insert, Labeling-Package Insert

Label is not available on this site.

02/13/2015 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

01/09/2014 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

DESLORATADINE

TABLET;ORAL; 5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CLARINEX DESLORATADINE 5MG TABLET;ORAL Prescription Yes AB 021165 MERCK SHARP DOHME
DESLORATADINE DESLORATADINE 5MG TABLET;ORAL Prescription No AB 078355 BELCHER PHARMS
DESLORATADINE DESLORATADINE 5MG TABLET;ORAL Prescription No AB 078365 DR REDDYS LABS LTD
DESLORATADINE DESLORATADINE 5MG TABLET;ORAL Prescription No AB 078352 LUPIN PHARMS
DESLORATADINE DESLORATADINE 5MG TABLET;ORAL Prescription No AB 078357 ORCHID HLTHCARE
DESLORATADINE DESLORATADINE 5MG TABLET;ORAL Prescription No AB 078361 PERRIGO
DESLORATADINE DESLORATADINE 5MG TABLET;ORAL Prescription No AB 078364 SANDOZ
DESLORATADINE DESLORATADINE 5MG TABLET;ORAL Prescription No AB 078359 SUN PHARM INDS

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English