Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076134
Company: SUN PHARM INDS LTD
Company: SUN PHARM INDS LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LORATADINE | LORATADINE | 10MG | TABLET;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 |
---|---|---|---|---|---|---|---|
08/18/2003 | ORIG-1 | Approval |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/76134.ta.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/076134Orig1Approv.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
03/24/2009 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
03/23/2007 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
04/16/2007 | SUPPL-8 | Labeling |
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;ORAL; 10MG
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
---|---|---|---|---|---|---|---|
CLARITIN | LORATADINE | 10MG | TABLET;ORAL | Over-the-counter | Yes | 019658 | BAYER HEALTHCARE LLC |
CLARITIN HIVES RELIEF | LORATADINE | 10MG | TABLET;ORAL | Over-the-counter | Yes | 019658 | BAYER HEALTHCARE LLC |
LORATADINE | LORATADINE | 10MG | TABLET;ORAL | Over-the-counter | No | 076471 | APOTEX INC |
LORATADINE | LORATADINE | 10MG | TABLET;ORAL | Over-the-counter | No | 208314 | AUROBINDO PHARMA LTD |
LORATADINE | LORATADINE | 10MG | TABLET;ORAL | Over-the-counter | No | 210722 | GRANULES |
LORATADINE | LORATADINE | 10MG | TABLET;ORAL | Over-the-counter | No | 207569 | GUARDIAN DRUG |
LORATADINE | LORATADINE | 10MG | TABLET;ORAL | Over-the-counter | No | 211718 | HETERO LABS LTD V |
LORATADINE | LORATADINE | 10MG | TABLET;ORAL | Over-the-counter | No | 076154 | MYLAN |
LORATADINE | LORATADINE | 10MG | TABLET;ORAL | Over-the-counter | No | 076301 | PERRIGO |
LORATADINE | LORATADINE | 10MG | TABLET;ORAL | Over-the-counter | No | 075209 | PLD ACQUISITIONS LLC |
LORATADINE | LORATADINE | 10MG | TABLET;ORAL | Over-the-counter | No | 076134 | SUN PHARM INDS LTD |
LORATADINE | LORATADINE | 10MG | TABLET;ORAL | Over-the-counter | No | 214684 | UNIQUE PHARM |