Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076011
Company: PERRIGO PHARMA INTL
Company: PERRIGO PHARMA INTL
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LORATADINE | 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 |
---|---|---|---|---|---|---|---|
09/29/2003 | ORIG-1 | Approval |
Label is not available on this site. |
LORATADINE
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 | FDN CONSUMER |
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 | 208477 | AUROBINDO PHARMA LTD |
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 | 214280 | RUBICON |
LORATADINE | LORATADINE | 10MG | TABLET, ORALLY DISINTEGRATING;ORAL | Over-the-counter | No | 213294 | TENSHI |
LORATADINE REDIDOSE | LORATADINE | 10MG | TABLET, ORALLY DISINTEGRATING;ORAL | Over-the-counter | No | 077153 | SUN PHARM INDS LTD |