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Details for New Drug Application (NDA): 078367

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NDA 078367 describes DESLORATADINE, which is a drug marketed by Taro, Mylan Pharms Inc, Lupin Pharms, Belcher Pharms, Orchid Hlthcare, Sun Pharm Inds, Perrigo R And D, Sandoz, Dr Reddys Labs Ltd, Reddys, and Taro Pharm Inds, and is included in twelve NDAs. It is available from twelve suppliers. Additional details are available on the DESLORATADINE profile page.

The generic ingredient in DESLORATADINE is desloratadine; pseudoephedrine sulfate. There are sixteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the desloratadine; pseudoephedrine sulfate profile page.

Summary for NDA: 078367

Therapeutic Class:Respiratory Tract Agents

Pharmacology for NDA: 078367

Suppliers and Packaging for NDA: 078367

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TABLET, ORALLY DISINTEGRATING;ORAL 078367 ANDA Dr. Reddy's Laboratories Limited 55111-360 55111-360-06 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (55111-360-06)
TABLET, ORALLY DISINTEGRATING;ORAL 078367 ANDA Dr. Reddy's Laboratories Limited 55111-360 55111-360-31 5 BLISTER PACK in 1 CARTON (55111-360-31) > 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK

Summary for product number 001

Approval Date:Jul 12, 2010TE:ABRLD:No

Summary for product number 002

Approval Date:Jul 12, 2010TE:ABRLD:No

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