Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021734
Company: TARO
Company: TARO
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LORATADINE | LORATADINE | 1MG/ML | SUSPENSION;ORAL | Over-the-counter | None | Yes | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
10/04/2005 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021734lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021734ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021734s000TOC.cfm |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
10/04/2005 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021734lbl.pdf |
LORATADINE
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
SUSPENSION;ORAL; 1MG/ML
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
---|---|---|---|---|---|---|---|
LORATADINE | LORATADINE | 1MG/ML | SUSPENSION;ORAL | Over-the-counter | Yes | 021734 | TARO |