Details for New Drug Application (NDA): 020704
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The generic ingredient in CLARITIN REDITABS 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 020704
Tradename: | CLARITIN REDITABS |
Applicant: | Bayer Healthcare Llc |
Ingredient: | loratadine |
Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 020704
Suppliers and Packaging for NDA: 020704
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CLARITIN HIVES RELIEF REDITAB | loratadine | TABLET, ORALLY DISINTEGRATING;ORAL | 020704 | NDA | Bayer Healthcare LLC. | 11523-4329 | 11523-4329-1 | 2 CARTON in 1 PACKAGE, COMBINATION (11523-4329-1) / 3 BLISTER PACK in 1 CARTON / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK |
CLARITIN HIVES RELIEF REDITAB | loratadine | TABLET, ORALLY DISINTEGRATING;ORAL | 020704 | NDA | Bayer Healthcare LLC. | 11523-4329 | 11523-4329-2 | 6 BLISTER PACK in 1 CARTON (11523-4329-2) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK |
Profile for product number 002
Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 10MG | ||||
Approval Date: | Nov 27, 2002 | TE: | RLD: | Yes |
Profile for product number 003
Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 10MG | ||||
Approval Date: | Nov 19, 2003 | TE: | RLD: | Yes |
Expired US Patents for NDA 020704
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Bayer Healthcare Llc | CLARITIN REDITABS | loratadine | TABLET, ORALLY DISINTEGRATING;ORAL | 020704-002 | Nov 27, 2002 | ⤷ Sign Up | ⤷ Sign Up |
Bayer Healthcare Llc | CLARITIN REDITABS | loratadine | TABLET, ORALLY DISINTEGRATING;ORAL | 020704-002 | Nov 27, 2002 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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