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Details for New Drug Application (NDA): 021150
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NDA 021150 describes ZYRTEC-D 12 HOUR, which is a drug marketed by J And J Consumer Inc and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the ZYRTEC-D 12 HOUR profile page.
The generic ingredient in ZYRTEC-D 12 HOUR is cetirizine hydrochloride; pseudoephedrine hydrochloride. There are thirty-nine drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the cetirizine hydrochloride; pseudoephedrine hydrochloride profile page.
The generic ingredient in ZYRTEC-D 12 HOUR is cetirizine hydrochloride; pseudoephedrine hydrochloride. There are thirty-nine drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the cetirizine hydrochloride; pseudoephedrine hydrochloride profile page.
Summary for 021150
| Tradename: | ZYRTEC-D 12 HOUR |
| Applicant: | J And J Consumer Inc |
| Ingredient: | cetirizine hydrochloride; pseudoephedrine hydrochloride |
| Patents: | 3 |
Suppliers and Packaging for NDA: 021150
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ZYRTEC-D 12 HOUR | cetirizine hydrochloride; pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021150 | NDA | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | 50580-728 | 50580-728-12 | 2 BLISTER PACK in 1 CARTON (50580-728-12) > 6 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK |
| ZYRTEC-D 12 HOUR | cetirizine hydrochloride; pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021150 | NDA | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | 50580-728 | 50580-728-24 | 4 BLISTER PACK in 1 CARTON (50580-728-24) > 6 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK |
Paragraph IV (Patent) Challenges for 021150
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| ZYRTEC-D 12 HOUR | TABLET, EXTENDED RELEASE;ORAL | cetirizine hydrochloride; pseudoephedrine hydrochloride | 021150 | 2004-06-02 |
Profile for product number 002
| Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 5MG;120MG | ||||
| Approval Date: | Nov 9, 2007 | TE: | RLD: | Yes | |||||
| Patent: | Start Trial | Patent Expiration: | Jul 13, 2019 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATMENT OF SEASONAL AND PERENNIAL ALLERGIC RHINITIS SYMPTOMS | ||||||||
| Patent: | Start Trial | Patent Expiration: | Jun 10, 2022 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | Start Trial | Patent Expiration: | Jun 10, 2022 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF SEASONAL AND PERENNIAL ALLERGIC RHINITIS SYMPTOMS | ||||||||
Expired US Patents for NDA 021150
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| J And J Consumer Inc | ZYRTEC-D 12 HOUR | cetirizine hydrochloride; pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021150-002 | Nov 9, 2007 | Start Trial | Start Trial |
| J And J Consumer Inc | ZYRTEC-D 12 HOUR | cetirizine hydrochloride; pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021150-002 | Nov 9, 2007 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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