Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076557
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 AND PSEUDOEPHEDRINE SULFATE | LORATADINE; PSEUDOEPHEDRINE SULFATE | 10MG;240MG | TABLET, EXTENDED RELEASE;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 |
---|---|---|---|---|---|---|---|
09/22/2004 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076557_original_approval_pkg.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
06/29/2010 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
||
09/20/2005 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
04/13/2005 | SUPPL-2 | Labeling |
Label is not available on this site. |
LORATADINE AND PSEUDOEPHEDRINE SULFATE
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
TABLET, EXTENDED RELEASE;ORAL; 10MG;240MG
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
---|---|---|---|---|---|---|---|
CLARITIN-D 24 HOUR | LORATADINE; PSEUDOEPHEDRINE SULFATE | 10MG;240MG | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | Yes | 020470 | BAYER HEALTHCARE LLC |
LORATADINE AND PSEUDOEPHEDRINE SULFATE | LORATADINE; PSEUDOEPHEDRINE SULFATE | 10MG;240MG | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | No | 218017 | BIONPHARMA |
LORATADINE AND PSEUDOEPHEDRINE SULFATE | LORATADINE; PSEUDOEPHEDRINE SULFATE | 10MG;240MG | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | No | 075706 | P AND L |
LORATADINE AND PSEUDOEPHEDRINE SULFATE | LORATADINE; PSEUDOEPHEDRINE SULFATE | 10MG;240MG | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | No | 075989 | PERRIGO PHARMA INTL |
LORATADINE AND PSEUDOEPHEDRINE SULFATE | LORATADINE; PSEUDOEPHEDRINE SULFATE | 10MG;240MG | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | No | 076557 | SUN PHARM INDS LTD |