Details for New Drug Application (NDA): 021993
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NDA 021993 describes CLARITIN REDITABS, which is a drug marketed by Bayer Healthcare Llc and is included in two NDAs. It is available from two suppliers. Additional details are available on the CLARITIN REDITABS profile page.
The generic ingredient in CLARITIN REDITABS 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.
The generic ingredient in CLARITIN REDITABS 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 021993
| Tradename: | CLARITIN REDITABS |
| Applicant: | Bayer Healthcare Llc |
| Ingredient: | loratadine |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
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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