Details for New Drug Application (NDA): 077153
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The generic ingredient in LORATADINE REDIDOSE is loratadine. There are thirty-nine drug master file entries for this compound. One hundred and fifty suppliers are listed for this compound. Additional details are available on the loratadine profile page.
Summary for 077153
Tradename: | LORATADINE REDIDOSE |
Applicant: | Sun Pharm Inds Ltd |
Ingredient: | loratadine |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Medical Subject Heading (MeSH) Categories for 077153
Suppliers and Packaging for NDA: 077153
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LORATADINE REDIDOSE | loratadine | TABLET, ORALLY DISINTEGRATING;ORAL | 077153 | ANDA | Ohm Laboratories Inc. | 51660-527 | 51660-527-31 | 30 BLISTER PACK in 1 CARTON (51660-527-31) / 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 10MG | ||||
Approval Date: | Apr 11, 2007 | TE: | RLD: | No |
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