Details for New Drug Application (NDA): 213294
✉ 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 213294
Tradename: | LORATADINE |
Applicant: | Tenshi |
Ingredient: | loratadine |
Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 213294
Suppliers and Packaging for NDA: 213294
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LORATADINE | loratadine | TABLET, ORALLY DISINTEGRATING;ORAL | 213294 | ANDA | Dr. Reddy's Laboratories Inc. | 43598-707 | 43598-707-30 | 3 BLISTER PACK in 1 CARTON (43598-707-30) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK |
LORATADINE | loratadine | TABLET, ORALLY DISINTEGRATING;ORAL | 213294 | ANDA | Dr. Reddy's Laboratories Inc. | 43598-758 | 43598-758-10 | 1 BLISTER PACK in 1 CARTON (43598-758-10) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 10MG | ||||
Approval Date: | Oct 30, 2020 | TE: | RLD: | No |
Complete Access Available with Subscription