Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076047
Company: CONTRACT PHARMACAL
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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/27/2007 ORIG-1 Approval Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/076047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/076047ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/27/2007 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/076047lbl.pdf

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 077318 CIPLA 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 202277 IPCA LABS LTD
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 ORCHID HLTHCARE
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 077499 SUN PHARM INDS INC
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 078072 TARO
CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG TABLET;ORAL Over-the-counter No 079191 TORRENT PHARMS LLC
CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG TABLET;ORAL Over-the-counter No 078680 UNICHEM
CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG TABLET;ORAL Over-the-counter No 077829 UNIQUE PHARM LABS
CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG TABLET;ORAL Over-the-counter No 078427 WOCKHARDT
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 202277 IPCA 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 ORCHID HLTHCARE
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 077499 SUN PHARM INDS INC
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 078680 UNICHEM
CETIRIZINE HYDROCHLORIDE HIVES CETIRIZINE HYDROCHLORIDE 5MG TABLET;ORAL Over-the-counter No 077829 UNIQUE PHARM LABS
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
CETIRIZINE HYDROCHLORIDE HIVES RELIEF CETIRIZINE HYDROCHLORIDE 5MG TABLET;ORAL Over-the-counter No 079191 TORRENT PHARMS LLC

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 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 077318 CIPLA 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 209274 GRANULES INDIA LTD
CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 10MG TABLET;ORAL Over-the-counter No 202277 IPCA LABS LTD
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 ORCHID HLTHCARE
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 077499 SUN PHARM INDS INC
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 079191 TORRENT PHARMS LLC
CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 10MG TABLET;ORAL Over-the-counter No 078680 UNICHEM
CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 10MG TABLET;ORAL Over-the-counter No 077829 UNIQUE PHARM LABS
CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 10MG TABLET;ORAL Over-the-counter No 078427 WOCKHARDT
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 202277 IPCA 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 ORCHID HLTHCARE
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 077499 SUN PHARM INDS INC
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 078680 UNICHEM
CETIRIZINE HYDROCHLORIDE HIVES CETIRIZINE HYDROCHLORIDE 10MG TABLET;ORAL Over-the-counter No 077829 UNIQUE PHARM LABS
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
CETIRIZINE HYDROCHLORIDE HIVES RELIEF CETIRIZINE HYDROCHLORIDE 10MG TABLET;ORAL Over-the-counter No 078072 TARO
CETIRIZINE HYDROCHLORIDE HIVES RELIEF CETIRIZINE HYDROCHLORIDE 10MG TABLET;ORAL Over-the-counter No 079191 TORRENT PHARMS LLC
ZYRTEC ALLERGY CETIRIZINE HYDROCHLORIDE 10MG TABLET;ORAL Over-the-counter Yes 019835 J AND J CONSUMER INC

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