Details for New Drug Application (NDA): 021993
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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 021993
Tradename: | CLARITIN REDITABS |
Applicant: | Bayer Healthcare Llc |
Ingredient: | loratadine |
Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 021993
Suppliers and Packaging for NDA: 021993
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CLARITIN REDITABS | loratadine | TABLET, ORALLY DISINTEGRATING;ORAL | 021993 | NDA | Bayer HealthCare LLC | 11523-7202 | 11523-7202-1 | 3 BLISTER PACK in 1 CARTON (11523-7202-1) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK |
CLARITIN REDITABS | loratadine | TABLET, ORALLY DISINTEGRATING;ORAL | 021993 | NDA | Bayer HealthCare LLC | 11523-7202 | 11523-7202-3 | 1 BLISTER PACK in 1 CARTON (11523-7202-3) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 5MG | ||||
Approval Date: | Dec 12, 2006 | TE: | RLD: | Yes |
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