Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 016832
Company: ABBOTT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CYLERT PEMOLINE 18.75MG TABLET;ORAL Discontinued None No No
CYLERT PEMOLINE 37.5MG TABLET;ORAL Discontinued None No No
CYLERT PEMOLINE 75MG TABLET;ORAL 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
01/27/1975 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/21/2003 SUPPL-22 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/016832s022_017703s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/16832slr022,17703slr018ltr.pdf
01/06/2003 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

09/12/2002 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

09/04/2002 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

05/28/1999 SUPPL-18 Labeling

Label is not available on this site.

05/08/1998 SUPPL-16 Manufacturing (CMC)-Packaging Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/016832a_s016.pdf
12/12/1997 SUPPL-15 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/016832a_s015.pdf
09/09/1996 SUPPL-14 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/1996-016832a_s014.pdf
04/11/1996 SUPPL-13 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/1996-016832a_s013.pdf
02/16/1990 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

06/15/1987 SUPPL-11 Labeling

Label is not available on this site.

09/06/1984 SUPPL-9 Labeling

Label is not available on this site.

03/30/1979 SUPPL-6 Labeling

Label is not available on this site.

06/06/1978 SUPPL-5 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/12/1977 SUPPL-4 Manufacturing (CMC)-Formulation

Label is not available on this site.

03/14/1979 SUPPL-3 Labeling

Label is not available on this site.

03/25/1975 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/21/2003 SUPPL-22 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/016832s022_017703s018lbl.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