Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 205564
Company: MACLEODS PHARMS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LEVOCETIRIZINE DIHYDROCHLORIDE LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET;ORAL Prescription AB 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
01/11/2016 ORIG-1 Approval STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/18/2017 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

09/18/2017 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

09/18/2017 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

LEVOCETIRIZINE DIHYDROCHLORIDE

TABLET;ORAL; 5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LEVOCETIRIZINE DIHYDROCHLORIDE LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 203027 APOTEX INC
LEVOCETIRIZINE DIHYDROCHLORIDE LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 090392 DR REDDYS LABS LTD
LEVOCETIRIZINE DIHYDROCHLORIDE LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 090385 GLENMARK GENERICS
LEVOCETIRIZINE DIHYDROCHLORIDE LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 091264 HETERO LABS LTD III
LEVOCETIRIZINE DIHYDROCHLORIDE LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 205564 MACLEODS PHARMS LTD
LEVOCETIRIZINE DIHYDROCHLORIDE LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 202046 MICRO LABS LTD INDIA
LEVOCETIRIZINE DIHYDROCHLORIDE LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 204323 NEOPHARMA
LEVOCETIRIZINE DIHYDROCHLORIDE LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 203646 SCIEGEN PHARMS INC
LEVOCETIRIZINE DIHYDROCHLORIDE LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 090362 SUN PHARM
LEVOCETIRIZINE DIHYDROCHLORIDE LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 201653 SUN PHARM INDS LTD
LEVOCETIRIZINE DIHYDROCHLORIDE LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 090229 SYNTHON PHARMS
LEVOCETIRIZINE DIHYDROCHLORIDE LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 090199 TEVA PHARMS
XYZAL LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET;ORAL Prescription Yes AB 022064 SANOFI AVENTIS US

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