Details for New Drug Application (NDA): 214684
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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 214684
Tradename: | LORATADINE |
Applicant: | Unique Pharm |
Ingredient: | loratadine |
Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 214684
Suppliers and Packaging for NDA: 214684
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LORATADINE | loratadine | TABLET;ORAL | 214684 | ANDA | Rising Pharmaceuticals, Inc | 16571-822 | 16571-822-01 | 100 TABLET in 1 BOTTLE (16571-822-01) |
LORATADINE | loratadine | TABLET;ORAL | 214684 | ANDA | Rising Pharmaceuticals, Inc | 16571-822 | 16571-822-03 | 30 TABLET in 1 BOTTLE (16571-822-03) |
Profile for product number 001
Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Jan 7, 2021 | TE: | RLD: | No |
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