Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021375
Company: PFIZER
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ALAVERT LORATADINE 10MG TABLET, ORALLY DISINTEGRATING;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
12/19/2002 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/021375lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-375_Alvert_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-375_Alvert.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/19/2005 SUPPL-2 Manufacturing (CMC)-Formulation Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021375s002ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/19/2002 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/021375lbl.pdf

ALAVERT

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

TABLET, ORALLY DISINTEGRATING;ORAL; 10MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
ALAVERT LORATADINE 10MG TABLET, ORALLY DISINTEGRATING;ORAL Over-the-counter No 021375 PFIZER
CLARITIN HIVES RELIEF REDITAB LORATADINE 10MG TABLET, ORALLY DISINTEGRATING;ORAL Over-the-counter Yes 020704 BAYER HEALTHCARE LLC
CLARITIN REDITABS LORATADINE 10MG TABLET, ORALLY DISINTEGRATING;ORAL Over-the-counter Yes 020704 BAYER HEALTHCARE LLC
LORATADINE LORATADINE 10MG TABLET, ORALLY DISINTEGRATING;ORAL Over-the-counter No 075990 ACTAVIS LABS FL INC
LORATADINE LORATADINE 10MG TABLET, ORALLY DISINTEGRATING;ORAL Over-the-counter No 076011 PERRIGO PHARMA INTL
LORATADINE LORATADINE 10MG TABLET, ORALLY DISINTEGRATING;ORAL Over-the-counter No 075822 PFIZER
LORATADINE REDIDOSE LORATADINE 10MG TABLET, ORALLY DISINTEGRATING;ORAL Over-the-counter No 077153 SUN PHARM INDS LTD

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