Details for New Drug Application (NDA): 021891
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NDA 021891 describes CLARITIN, which is a drug marketed by Bayer Healthcare Llc and is included in eight NDAs. It is available from six suppliers. Additional details are available on the CLARITIN profile page.
The generic ingredient in CLARITIN is loratadine; pseudoephedrine sulfate. There are thirty-nine drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the loratadine; pseudoephedrine sulfate profile page.
The generic ingredient in CLARITIN is loratadine; pseudoephedrine sulfate. There are thirty-nine drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the loratadine; pseudoephedrine sulfate profile page.
Summary for 021891
| Tradename: | CLARITIN |
| Applicant: | Bayer Healthcare Llc |
| Ingredient: | loratadine |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 021891
Suppliers and Packaging for NDA: 021891
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CHILDREN'S CLARITIN | loratadine | TABLET, CHEWABLE;ORAL | 021891 | NDA | Bayer HealthCare LLC. | 11523-0123 | 11523-0123-1 | 1 KIT in 1 CARTON (11523-0123-1) |
| CHILDREN'S CLARITIN | loratadine | TABLET, CHEWABLE;ORAL | 021891 | NDA | Bayer HealthCare LLC. | 11523-4328 | 11523-4328-1 | 1 BLISTER PACK in 1 CARTON (11523-4328-1) / 10 TABLET, CHEWABLE in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET, CHEWABLE;ORAL | Strength | 5MG | ||||
| Approval Date: | Aug 23, 2006 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET, CHEWABLE;ORAL | Strength | 10MG | ||||
| Approval Date: | Nov 21, 2018 | TE: | RLD: | Yes | |||||
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