Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076050
Company: PERRIGO PHARMA INTL
Company: PERRIGO PHARMA INTL
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LORATADINE AND PSEUDOEPHEDRINE SULFATE | LORATADINE; PSEUDOEPHEDRINE SULFATE | 5MG;120MG | 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 |
---|---|---|---|---|---|---|---|
01/30/2003 | ORIG-1 | Approval |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/76050APltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/076050Orig1Approv.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
10/21/2014 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/21/2005 | SUPPL-11 | Labeling |
Label is not available on this site. |
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09/22/2004 | SUPPL-7 | Labeling |
Label is not available on this site. |
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07/28/2004 | SUPPL-5 | 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; 5MG;120MG
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
---|---|---|---|---|---|---|---|
CLARITIN-D | LORATADINE; PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | Yes | 019670 | BAYER HEALTHCARE LLC |
LORATADINE AND PSEUDOEPHEDRINE SULFATE | LORATADINE; PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | No | 076050 | PERRIGO PHARMA INTL |