Details for New Drug Application (NDA): 019670
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NDA 019670 describes CLARITIN-D, which is a drug marketed by Bayer Healthcare Llc and is included in two NDAs. It is available from one supplier. Additional details are available on the CLARITIN-D profile page.
The generic ingredient in CLARITIN-D is loratadine; pseudoephedrine sulfate. There are thirty-nine drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the loratadine; pseudoephedrine sulfate profile page.
The generic ingredient in CLARITIN-D is loratadine; pseudoephedrine sulfate. There are thirty-nine drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the loratadine; pseudoephedrine sulfate profile page.
Summary for 019670
| Tradename: | CLARITIN-D |
| Applicant: | Bayer Healthcare Llc |
| Ingredient: | loratadine; pseudoephedrine sulfate |
| Patents: | 0 |
Pharmacology for NDA: 019670
| Mechanism of Action | Adrenergic alpha-Agonists |
Suppliers and Packaging for NDA: 019670
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CLARITIN-D | loratadine; pseudoephedrine sulfate | TABLET, EXTENDED RELEASE;ORAL | 019670 | NDA | Bayer HealthCare LLC. | 11523-7162 | 11523-7162-1 | 1 BLISTER PACK in 1 CARTON (11523-7162-1) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK |
| CLARITIN-D | loratadine; pseudoephedrine sulfate | TABLET, EXTENDED RELEASE;ORAL | 019670 | NDA | Bayer HealthCare LLC. | 11523-7162 | 11523-7162-2 | 2 BLISTER PACK in 1 CARTON (11523-7162-2) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK |
Profile for product number 002
| Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 5MG;120MG | ||||
| Approval Date: | Nov 27, 2002 | TE: | RLD: | Yes | |||||
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