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DESLORATADINE

ANDA

DESLORATADINE | A078357 | ORBION PHARMACEUTICALS PRIVATE LTD

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: CLARINEX(TE code: AB)

API Supply Chain10 active DMFs6 inactive

10 active API suppliers hold Drug Master Files for this ingredient.

MOREPEN LABORATORIES LTDDESLORATADINE

DMF 176522004

SUN PHARMACEUTICAL INDUSTRIES LTDDESLORATADINE

DMF 190142005

LUPIN LTDDESLORATADINE USP

DMF 190832005

ORBION PHARMACEUTICALS PRIVATE LTDDESLORATADINE

DMF 193392006

ALIVUS LIFE SCIENCES LTDDESLORATADINE

DMF 194282006

DR REDDYS LABORATORIES LTDDESLORATADINE USP

DMF 194562006

CADILA PHARMACEUTICALS LTDDESLORATADINE

DMF 211332007

MATRIX PHARMACORP PRIVATE LTDDESLORATADINE USP

DMF 211872007

TARO PHARMACEUTICAL INDUSTRIES LTDDESLORATADINE

DMF 242752010

VASUDHA PHARMA CHEM LTDDESLORATADINE USP

DMF 288252014

CIPLA LTDInactiveDESLORATADINE

DMF 191822006

TEVA PHARMACEUTICAL INDUSTRIES LTDInactiveDESLORATADINE DRUG SUBSTANCE

DMF 194032006

DIVIS LABORATORIES LTDInactiveDESLORATADINE

DMF 194412006

SUN PHARMACEUTICAL INDUSTRIES LTDInactiveDESLORATADINE DRUG SUBSTANCE

DMF 195082006

CIPLA LTDInactiveDESLORATADINE FORM I: FORM II (89:11)

DMF 223122009

HAINAN POLY PHARMACEUTICAL CO LTDInactiveDESLORATADINE

DMF 239262010

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Mar 30, 2010	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 5MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Feb 19, 2010

No patent or exclusivity listings for this strength.