Drugs@FDA: FDA-Approved Drugs
Company: PHARM RES ASSOC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CERUMENEX | TROLAMINE POLYPEPTIDE OLEATE CONDENSATE | 10% | SOLUTION/DROPS;OTIC | Discontinued | 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 |
---|---|---|---|---|---|---|---|
06/25/1958 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/17/2002 | SUPPL-16 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/11340s16lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/11340s16ltr.pdf | |
11/09/2000 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/09/2000 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/09/2000 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/09/2000 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/09/2000 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/09/2000 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/11/2000 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
08/21/1991 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
12/02/1988 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
06/04/1981 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
10/07/1977 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
04/17/2002 | SUPPL-16 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/11340s16lbl.pdf |