Details for New Drug Application (NDA): 211926
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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 211926
Tradename: | LORATADINE |
Applicant: | Strides Pharma |
Ingredient: | loratadine |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Medical Subject Heading (MeSH) Categories for 211926
Suppliers and Packaging for NDA: 211926
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LORATADINE | loratadine | CAPSULE;ORAL | 211926 | ANDA | Strides Pharma Inc | 59556-882 | 59556-882-01 | 1 BLISTER PACK in 1 CARTON (59556-882-01) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK |
LORATADINE | loratadine | CAPSULE;ORAL | 211926 | ANDA | Strides Pharma Inc | 59556-882 | 59556-882-81 | 3 BLISTER PACK in 1 CARTON (59556-882-81) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 10MG | ||||
Approval Date: | Jan 15, 2020 | TE: | RLD: | No |
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