Details for New Drug Application (NDA): 075728
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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-four suppliers are listed for this compound. Additional details are available on the loratadine; pseudoephedrine sulfate profile page.
Summary for 075728
Tradename: | LORATADINE |
Applicant: | Perrigo |
Ingredient: | loratadine |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Medical Subject Heading (MeSH) Categories for 075728
Suppliers and Packaging for NDA: 075728
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LORATADINE | loratadine | SYRUP;ORAL | 075728 | ANDA | L. Perrigo Company | 0113-0671 | 0113-0671-26 | 1 BOTTLE in 1 CARTON (0113-0671-26) / 120 mL in 1 BOTTLE |
LORATADINE | loratadine | SYRUP;ORAL | 075728 | ANDA | L. Perrigo Company | 0113-1719 | 0113-1719-06 | 1 BOTTLE in 1 CARTON (0113-1719-06) / 240 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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