Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 210719
Company: PPI-DAC
Company: PPI-DAC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE | 5MG;120MG | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | None | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
11/16/2018 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
TABLET, EXTENDED RELEASE;ORAL; 5MG;120MG
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
---|---|---|---|---|---|---|---|
CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE | 5MG;120MG | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | No | 077170 | IVAX SUB TEVA PHARMS |
CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE | 5MG;120MG | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | No | 077991 | PLD ACQUISITIONS |
CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE | 5MG;120MG | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | No | 210719 | PPI-DAC |
CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE | 5MG;120MG | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | No | 090922 | SUN PHARM INDS LTD |
CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE | 5MG;120MG | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | No | 210507 | UNICHEM |
ZYRTEC-D 12 HOUR | CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE | 5MG;120MG | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | Yes | 021150 | J AND J CONSUMER INC |