Details for New Drug Application (NDA): 020641
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The generic ingredient in CLARITIN HIVES RELIEF is loratadine. There are thirty-nine drug master file entries for this compound. One hundred and fifty suppliers are listed for this compound. Additional details are available on the loratadine profile page.
Summary for 020641
Tradename: | CLARITIN HIVES RELIEF |
Applicant: | Bayer Healthcare Llc |
Ingredient: | loratadine |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Medical Subject Heading (MeSH) Categories for 020641
Suppliers and Packaging for NDA: 020641
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CLARITIN | loratadine | SYRUP;ORAL | 020641 | NDA | Bayer HealthCare LLC. | 11523-4360 | 11523-4360-1 | 1 BOTTLE in 1 CARTON (11523-4360-1) / 60 mL in 1 BOTTLE |
CLARITIN | loratadine | SYRUP;ORAL | 020641 | NDA | Bayer HealthCare LLC. | 11523-4360 | 11523-4360-2 | 1 BOTTLE in 1 CARTON (11523-4360-2) / 120 mL in 1 BOTTLE |
Profile for product number 002
Active Rx/OTC/Discontinued: | OTC | Dosage: | SYRUP;ORAL | Strength | 1MG/ML | ||||
Approval Date: | Nov 27, 2002 | TE: | RLD: | Yes |
Profile for product number 003
Active Rx/OTC/Discontinued: | DISCN | Dosage: | SYRUP;ORAL | Strength | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Nov 19, 2003 | TE: | RLD: | Yes |
Expired US Patents for NDA 020641
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Bayer Healthcare Llc | CLARITIN | loratadine | SYRUP;ORAL | 020641-002 | Nov 27, 2002 | ⤷ Try a Trial | ⤷ Try a Trial |
Bayer Healthcare Llc | CLARITIN | loratadine | SYRUP;ORAL | 020641-002 | Nov 27, 2002 | ⤷ Try a Trial | ⤷ Try a Trial |
Bayer Healthcare Llc | CLARITIN | loratadine | SYRUP;ORAL | 020641-002 | Nov 27, 2002 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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