Details for New Drug Application (NDA): 075209
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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 075209
Tradename: | LORATADINE |
Applicant: | Pld Acquisitions Llc |
Ingredient: | loratadine |
Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 075209
Suppliers and Packaging for NDA: 075209
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LORATADINE | loratadine | TABLET;ORAL | 075209 | ANDA | Walgreens | 0363-0858 | 0363-0858-03 | 1 BOTTLE, PLASTIC in 1 BOX (0363-0858-03) / 30 TABLET in 1 BOTTLE, PLASTIC |
LORATADINE | loratadine | TABLET;ORAL | 075209 | ANDA | Walgreens | 0363-0858 | 0363-0858-05 | 5 BLISTER PACK in 1 CARTON (0363-0858-05) / 1 TABLET in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Jan 21, 2003 | TE: | RLD: | No |
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