Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 207916
Company: ARBOR PHARMS LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CETYLEV ACETYLCYSTEINE 500MG TABLET, EFFERVESCENT;ORAL Discontinued None Yes No
CETYLEV ACETYLCYSTEINE 2.5GM TABLET, EFFERVESCENT;ORAL Discontinued None Yes 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
01/29/2016 ORIG-1 Approval Type 3 - New Dosage Form STANDARD; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207916s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207916Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/207916_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/16/2018 SUPPL-4 Labeling-Container/Carton Labels

Label is not available on this site.

04/18/2017 SUPPL-3 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207916s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207916Orig1s003ltr.pdf
07/20/2017 SUPPL-2 Labeling-Container/Carton Labels

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/18/2017 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207916s003lbl.pdf
01/29/2016 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207916s000lbl.pdf

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English