Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 206214
Company: MARKSANS PHARMA
Company: MARKSANS PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LORATADINE | LORATADINE | 10MG | CAPSULE;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 |
---|---|---|---|---|---|---|---|
09/23/2016 | ORIG-1 | Approval | STANDARD |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206214Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206214Orig1s000ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
09/23/2016 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206214Orig1s000lbl.pdf |
LORATADINE
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
CAPSULE;ORAL; 10MG
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
---|---|---|---|---|---|---|---|
CLARITIN | LORATADINE | 10MG | CAPSULE;ORAL | Over-the-counter | Yes | 021952 | BAYER HEALTHCARE LLC |
LORATADINE | LORATADINE | 10MG | CAPSULE;ORAL | Over-the-counter | No | 202538 | BIONPHARMA |
LORATADINE | LORATADINE | 10MG | CAPSULE;ORAL | Over-the-counter | No | 206214 | MARKSANS PHARMA |