Details for New Drug Application (NDA): 077421
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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 077421
Tradename: | LORATADINE |
Applicant: | Lannett Co Inc |
Ingredient: | loratadine |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Medical Subject Heading (MeSH) Categories for 077421
Suppliers and Packaging for NDA: 077421
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LORATADINE | loratadine | SYRUP;ORAL | 077421 | ANDA | MEIJER, INC. | 41250-539 | 41250-539-04 | 1 BOTTLE, PLASTIC in 1 BOX (41250-539-04) / 120 mL in 1 BOTTLE, PLASTIC |
LORATADINE | loratadine | SYRUP;ORAL | 077421 | ANDA | A-S Medication Solutions | 50090-1454 | 50090-1454-0 | 120 mL in 1 CARTON (50090-1454-0) |
Profile for product number 001
Active Rx/OTC/Discontinued: | OTC | Dosage: | SYRUP;ORAL | Strength | 1MG/ML | ||||
Approval Date: | Jun 29, 2006 | TE: | RLD: | No |
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