Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078862
Company: ORBION PHARMS
Company: ORBION PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Over-the-counter | None | No | No |
| CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Over-the-counter | None | No | No |
| CETIRIZINE HYDROCHLORIDE HIVES | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Over-the-counter | None | No | No |
| CETIRIZINE HYDROCHLORIDE HIVES | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET;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 |
|---|---|---|---|---|---|---|---|
| 02/19/2009 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/05/2014 | SUPPL-3 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 11/07/2014 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
CETIRIZINE HYDROCHLORIDE ALLERGY
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
TABLET;ORAL; 5MG
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Over-the-counter | No | 078780 | AMNEAL PHARMS NY |
| CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Over-the-counter | No | 078317 | APOTEX INC |
| CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Over-the-counter | No | 090760 | AUROBINDO PHARMA LTD |
| CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Over-the-counter | No | 076047 | CONTRACT PHARMACAL |
| CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Over-the-counter | No | 078343 | DR REDDYS LABS LTD |
| CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Over-the-counter | No | 078427 | GLENMARK PHARMS INC |
| CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Over-the-counter | No | 078933 | MARKSANS PHARMA |
| CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Over-the-counter | No | 076677 | MYLAN |
| CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Over-the-counter | No | 078862 | ORBION PHARMS |
| CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Over-the-counter | No | 078336 | PERRIGO R AND D |
| CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Over-the-counter | No | 077946 | PLD ACQUISITIONS |
| CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Over-the-counter | No | 077498 | SUN PHARM INDS LTD |
| CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Over-the-counter | No | 077829 | UNIQUE |
| CETIRIZINE HYDROCHLORIDE HIVES | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Over-the-counter | No | 078343 | DR REDDYS LABS LTD |
| CETIRIZINE HYDROCHLORIDE HIVES | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Over-the-counter | No | 078933 | MARKSANS PHARMA |
| CETIRIZINE HYDROCHLORIDE HIVES | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Over-the-counter | No | 076677 | MYLAN |
| CETIRIZINE HYDROCHLORIDE HIVES | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Over-the-counter | No | 078862 | ORBION PHARMS |
| CETIRIZINE HYDROCHLORIDE HIVES | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Over-the-counter | No | 078336 | PERRIGO R AND D |
| CETIRIZINE HYDROCHLORIDE HIVES | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Over-the-counter | No | 077498 | SUN PHARM INDS LTD |
| CETIRIZINE HYDROCHLORIDE HIVES | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Over-the-counter | No | 077829 | UNIQUE |
| CETIRIZINE HYDROCHLORIDE HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Over-the-counter | No | 078780 | AMNEAL PHARMS NY |
| CETIRIZINE HYDROCHLORIDE HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Over-the-counter | No | 090760 | AUROBINDO PHARMA LTD |
| ZYRTEC ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Over-the-counter | Yes | 019835 | KENVUE BRANDS |
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
TABLET;ORAL; 10MG
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| CETIRIZINE HYDROCHLORIDE | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Over-the-counter | No | 218895 | REGCON HOLDINGS |
| CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Over-the-counter | No | 078780 | AMNEAL PHARMS NY |
| CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Over-the-counter | No | 078317 | APOTEX INC |
| CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Over-the-counter | No | 090760 | AUROBINDO PHARMA LTD |
| CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Over-the-counter | No | 076047 | CONTRACT PHARMACAL |
| CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Over-the-counter | No | 078343 | DR REDDYS LABS LTD |
| CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Over-the-counter | No | 078427 | GLENMARK PHARMS INC |
| CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Over-the-counter | No | 209274 | GRANULES |
| CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Over-the-counter | No | 078933 | MARKSANS PHARMA |
| CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Over-the-counter | No | 076677 | MYLAN |
| CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Over-the-counter | No | 078862 | ORBION PHARMS |
| CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Over-the-counter | No | 078336 | PERRIGO R AND D |
| CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Over-the-counter | No | 077946 | PLD ACQUISITIONS |
| CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Over-the-counter | No | 077498 | SUN PHARM INDS LTD |
| CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Over-the-counter | No | 077829 | UNIQUE |
| CETIRIZINE HYDROCHLORIDE HIVES | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Over-the-counter | No | 078343 | DR REDDYS LABS LTD |
| CETIRIZINE HYDROCHLORIDE HIVES | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Over-the-counter | No | 078933 | MARKSANS PHARMA |
| CETIRIZINE HYDROCHLORIDE HIVES | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Over-the-counter | No | 076677 | MYLAN |
| CETIRIZINE HYDROCHLORIDE HIVES | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Over-the-counter | No | 078862 | ORBION PHARMS |
| CETIRIZINE HYDROCHLORIDE HIVES | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Over-the-counter | No | 078336 | PERRIGO R AND D |
| CETIRIZINE HYDROCHLORIDE HIVES | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Over-the-counter | No | 077498 | SUN PHARM INDS LTD |
| CETIRIZINE HYDROCHLORIDE HIVES | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Over-the-counter | No | 077829 | UNIQUE |
| CETIRIZINE HYDROCHLORIDE HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Over-the-counter | No | 078780 | AMNEAL PHARMS NY |
| CETIRIZINE HYDROCHLORIDE HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Over-the-counter | No | 090760 | AUROBINDO PHARMA LTD |
| ZYRTEC ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Over-the-counter | Yes | 019835 | KENVUE BRANDS |
CETIRIZINE HYDROCHLORIDE HIVES
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
TABLET;ORAL; 5MG
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Over-the-counter | No | 078780 | AMNEAL PHARMS NY |
| CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Over-the-counter | No | 078317 | APOTEX INC |
| CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Over-the-counter | No | 090760 | AUROBINDO PHARMA LTD |
| CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Over-the-counter | No | 076047 | CONTRACT PHARMACAL |
| CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Over-the-counter | No | 078343 | DR REDDYS LABS LTD |
| CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Over-the-counter | No | 078427 | GLENMARK PHARMS INC |
| CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Over-the-counter | No | 078933 | MARKSANS PHARMA |
| CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Over-the-counter | No | 076677 | MYLAN |
| CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Over-the-counter | No | 078862 | ORBION PHARMS |
| CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Over-the-counter | No | 078336 | PERRIGO R AND D |
| CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Over-the-counter | No | 077946 | PLD ACQUISITIONS |
| CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Over-the-counter | No | 077498 | SUN PHARM INDS LTD |
| CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Over-the-counter | No | 077829 | UNIQUE |
| CETIRIZINE HYDROCHLORIDE HIVES | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Over-the-counter | No | 078343 | DR REDDYS LABS LTD |
| CETIRIZINE HYDROCHLORIDE HIVES | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Over-the-counter | No | 078933 | MARKSANS PHARMA |
| CETIRIZINE HYDROCHLORIDE HIVES | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Over-the-counter | No | 076677 | MYLAN |
| CETIRIZINE HYDROCHLORIDE HIVES | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Over-the-counter | No | 078862 | ORBION PHARMS |
| CETIRIZINE HYDROCHLORIDE HIVES | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Over-the-counter | No | 078336 | PERRIGO R AND D |
| CETIRIZINE HYDROCHLORIDE HIVES | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Over-the-counter | No | 077498 | SUN PHARM INDS LTD |
| CETIRIZINE HYDROCHLORIDE HIVES | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Over-the-counter | No | 077829 | UNIQUE |
| CETIRIZINE HYDROCHLORIDE HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Over-the-counter | No | 078780 | AMNEAL PHARMS NY |
| CETIRIZINE HYDROCHLORIDE HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Over-the-counter | No | 090760 | AUROBINDO PHARMA LTD |
| ZYRTEC ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Over-the-counter | Yes | 019835 | KENVUE BRANDS |
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
TABLET;ORAL; 10MG
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| CETIRIZINE HYDROCHLORIDE | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Over-the-counter | No | 218895 | REGCON HOLDINGS |
| CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Over-the-counter | No | 078780 | AMNEAL PHARMS NY |
| CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Over-the-counter | No | 078317 | APOTEX INC |
| CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Over-the-counter | No | 090760 | AUROBINDO PHARMA LTD |
| CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Over-the-counter | No | 076047 | CONTRACT PHARMACAL |
| CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Over-the-counter | No | 078343 | DR REDDYS LABS LTD |
| CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Over-the-counter | No | 078427 | GLENMARK PHARMS INC |
| CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Over-the-counter | No | 209274 | GRANULES |
| CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Over-the-counter | No | 078933 | MARKSANS PHARMA |
| CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Over-the-counter | No | 076677 | MYLAN |
| CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Over-the-counter | No | 078862 | ORBION PHARMS |
| CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Over-the-counter | No | 078336 | PERRIGO R AND D |
| CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Over-the-counter | No | 077946 | PLD ACQUISITIONS |
| CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Over-the-counter | No | 077498 | SUN PHARM INDS LTD |
| CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Over-the-counter | No | 077829 | UNIQUE |
| CETIRIZINE HYDROCHLORIDE HIVES | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Over-the-counter | No | 078343 | DR REDDYS LABS LTD |
| CETIRIZINE HYDROCHLORIDE HIVES | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Over-the-counter | No | 078933 | MARKSANS PHARMA |
| CETIRIZINE HYDROCHLORIDE HIVES | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Over-the-counter | No | 076677 | MYLAN |
| CETIRIZINE HYDROCHLORIDE HIVES | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Over-the-counter | No | 078862 | ORBION PHARMS |
| CETIRIZINE HYDROCHLORIDE HIVES | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Over-the-counter | No | 078336 | PERRIGO R AND D |
| CETIRIZINE HYDROCHLORIDE HIVES | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Over-the-counter | No | 077498 | SUN PHARM INDS LTD |
| CETIRIZINE HYDROCHLORIDE HIVES | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Over-the-counter | No | 077829 | UNIQUE |
| CETIRIZINE HYDROCHLORIDE HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Over-the-counter | No | 078780 | AMNEAL PHARMS NY |
| CETIRIZINE HYDROCHLORIDE HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Over-the-counter | No | 090760 | AUROBINDO PHARMA LTD |
| ZYRTEC ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Over-the-counter | Yes | 019835 | KENVUE BRANDS |