Details for New Drug Application (NDA): 202538
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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 202538
Tradename: | LORATADINE |
Applicant: | Bionpharma |
Ingredient: | loratadine |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Medical Subject Heading (MeSH) Categories for 202538
Suppliers and Packaging for NDA: 202538
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LORATADINE | loratadine | CAPSULE;ORAL | 202538 | ANDA | Rite Aid Corporation | 11822-0446 | 11822-0446-0 | 30 BLISTER PACK in 1 CARTON (11822-0446-0) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK |
LORATADINE | loratadine | CAPSULE;ORAL | 202538 | ANDA | Rite Aid Corporation | 11822-2022 | 11822-2022-3 | 1 BLISTER PACK in 1 CARTON (11822-2022-3) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | OTC | Dosage: | CAPSULE;ORAL | Strength | 10MG | ||||
Approval Date: | Dec 21, 2018 | TE: | RLD: | No |
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