Details for New Drug Application (NDA): 211718
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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 211718
Tradename: | LORATADINE |
Applicant: | Hetero Labs Ltd V |
Ingredient: | loratadine |
Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 211718
Suppliers and Packaging for NDA: 211718
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LORATADINE | loratadine | TABLET;ORAL | 211718 | ANDA | Preferred Pharmaceuticals Inc. | 68788-8605 | 68788-8605-0 | 10 TABLET in 1 BOTTLE (68788-8605-0) |
LORATADINE | loratadine | TABLET;ORAL | 211718 | ANDA | Preferred Pharmaceuticals Inc. | 68788-8605 | 68788-8605-1 | 14 TABLET in 1 BOTTLE (68788-8605-1) |
Profile for product number 001
Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Jul 28, 2023 | TE: | RLD: | No |
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