Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 090229
Company: SYNTHON PHARMS
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
11/26/2010 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/090229s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/07/2017 SUPPL-16 Labeling-Container/Carton Labels

Label is not available on this site.

06/29/2015 SUPPL-13 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

06/29/2015 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

06/29/2015 SUPPL-7 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

06/30/2011 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

06/27/2011 SUPPL-3 Labeling-Container/Carton Labels

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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