CERUMENEX از شرکت PHARM RES ASSOC

اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است

CERUMENEX از شرکت PHARM RES ASSOC

New Drug Application (NDA): 011340

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
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