Details for New Drug Application (NDA): 210409
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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 210409
Tradename: | LORATADINE |
Applicant: | Hetero Labs Ltd Iii |
Ingredient: | loratadine |
Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 210409
Suppliers and Packaging for NDA: 210409
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LORATADINE | loratadine | SYRUP;ORAL | 210409 | ANDA | Camber Consumer Care Inc | 69230-322 | 69230-322-12 | 1 BOTTLE in 1 CARTON (69230-322-12) / 120 mL in 1 BOTTLE |
LORATADINE | loratadine | SYRUP;ORAL | 210409 | ANDA | Camber Consumer Care Inc | 69230-322 | 69230-322-24 | 1 BOTTLE in 1 CARTON (69230-322-24) / 240 mL in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | OTC | Dosage: | SYRUP;ORAL | Strength | 1MG/ML | ||||
Approval Date: | May 7, 2021 | TE: | RLD: | No |
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