Details for New Drug Application (NDA): 211900
✉ Email this page to a colleague
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 211900
Tradename: | LORATADINE |
Applicant: | Aurobindo Pharma |
Ingredient: | loratadine |
Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 211900
Suppliers and Packaging for NDA: 211900
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LORATADINE | loratadine | CAPSULE;ORAL | 211900 | ANDA | Aurohealth LLC | 58602-818 | 58602-818-05 | 5 BLISTER PACK in 1 CARTON (58602-818-05) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK |
LORATADINE | loratadine | CAPSULE;ORAL | 211900 | ANDA | Aurohealth LLC | 58602-818 | 58602-818-08 | 4 BLISTER PACK in 1 CARTON (58602-818-08) / 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: | Mar 24, 2023 | TE: | RLD: | No |
Complete Access Available with Subscription