Details for New Drug Application (NDA): 019658
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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 019658
Tradename: | CLARITIN HIVES RELIEF |
Applicant: | Bayer Healthcare Llc |
Ingredient: | loratadine |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Medical Subject Heading (MeSH) Categories for 019658
Suppliers and Packaging for NDA: 019658
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CLARITIN | loratadine | TABLET;ORAL | 019658 | NDA | Bayer HealthCare LLC. | 11523-1527 | 11523-1527-1 | 50 POUCH in 1 BOX (11523-1527-1) / 1 TABLET in 1 POUCH |
CLARITIN | loratadine | TABLET;ORAL | 019658 | NDA | Bayer HealthCare LLC. | 11523-1527 | 11523-1527-2 | 50 POUCH in 1 BOX (11523-1527-2) / 1 TABLET in 1 POUCH |
Profile for product number 002
Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Nov 27, 2002 | TE: | RLD: | Yes |
Profile for product number 003
Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Nov 19, 2003 | TE: | RLD: | Yes |
Expired US Patents for NDA 019658
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Bayer Healthcare Llc | CLARITIN | loratadine | TABLET;ORAL | 019658-002 | Nov 27, 2002 | ⤷ Try a Trial | ⤷ Try a Trial |
Bayer Healthcare Llc | CLARITIN | loratadine | TABLET;ORAL | 019658-002 | 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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