Details for New Drug Application (NDA): 210088
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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-five suppliers are listed for this compound. Additional details are available on the loratadine; pseudoephedrine sulfate profile page.
Summary for 210088
Tradename: | LORATADINE |
Applicant: | Sun Pharm |
Ingredient: | loratadine |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Medical Subject Heading (MeSH) Categories for 210088
Suppliers and Packaging for NDA: 210088
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LORATADINE | loratadine | TABLET, CHEWABLE;ORAL | 210088 | ANDA | WALGREEN COMPANY | 0363-0752 | 0363-0752-30 | 3 BLISTER PACK in 1 CARTON (0363-0752-30) / 10 TABLET, CHEWABLE in 1 BLISTER PACK |
LORATADINE | loratadine | TABLET, CHEWABLE;ORAL | 210088 | ANDA | Walgreens | 0363-0754 | 0363-0754-30 | 3 BLISTER PACK in 1 CARTON (0363-0754-30) / 10 TABLET, CHEWABLE in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET, CHEWABLE;ORAL | Strength | 5MG | ||||
Approval Date: | Apr 16, 2018 | TE: | RLD: | No |
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