Details for New Drug Application (NDA): 076805
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The generic ingredient in LORATADINE is loratadine; pseudoephedrine sulfate. There are thirty-nine drug master file entries for this compound. Thirty-two suppliers are listed for this compound. Additional details are available on the loratadine; pseudoephedrine sulfate profile page.
Summary for 076805
Tradename: | LORATADINE |
Applicant: | Taro |
Ingredient: | loratadine |
Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 076805
Suppliers and Packaging for NDA: 076805
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LORATADINE | loratadine | SYRUP;ORAL | 076805 | ANDA | Walgreen Company | 0363-2131 | 0363-2131-08 | 1 BOTTLE in 1 CARTON (0363-2131-08) / 120 mL in 1 BOTTLE |
LORATADINE | loratadine | SYRUP;ORAL | 076805 | ANDA | Rite Aid Corporation | 11822-2131 | 11822-2131-8 | 1 BOTTLE in 1 CARTON (11822-2131-8) / 120 mL in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | OTC | Dosage: | SYRUP;ORAL | Strength | 1MG/ML | ||||
Approval Date: | Aug 20, 2004 | TE: | RLD: | No |
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