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-five 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 |
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. | 11523-0101 | 11523-0101-1 | 1 BOTTLE in 1 CARTON (11523-0101-1) / 30 mL in 1 BOTTLE |
CLARITIN | loratadine | SYRUP;ORAL | 020641 | NDA | Bayer HealthCare LLC. | 11523-0101 | 11523-0101-2 | 1 BOTTLE in 1 CARTON (11523-0101-2) / 80 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DISCN | Dosage: | SYRUP;ORAL | Strength | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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 | ⤷ Sign Up | ⤷ Sign Up |
Bayer Healthcare Llc | CLARITIN | loratadine | SYRUP;ORAL | 020641-002 | Nov 27, 2002 | ⤷ Sign Up | ⤷ Sign Up |
Bayer Healthcare Llc | CLARITIN | loratadine | SYRUP;ORAL | 020641-002 | Nov 27, 2002 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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