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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. Forty-three 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. Forty-three 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 |
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 |
Paragraph IV (Patent) Challenges for 019670
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| CLARITIN-D | TABLET, EXTENDED RELEASE;ORAL | loratadine; pseudoephedrine sulfate | 019670 |
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 | |||||
Expired US Patents for NDA 019670
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Bayer Healthcare Llc | CLARITIN-D | loratadine; pseudoephedrine sulfate | TABLET, EXTENDED RELEASE;ORAL | 019670-002 | Nov 27, 2002 | Start Trial | Start Trial |
| Bayer Healthcare Llc | CLARITIN-D | loratadine; pseudoephedrine sulfate | TABLET, EXTENDED RELEASE;ORAL | 019670-002 | Nov 27, 2002 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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