Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 075219
Company: TEVA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DICLOFENAC POTASSIUM DICLOFENAC POTASSIUM 50MG TABLET;ORAL Prescription AB 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
08/06/1998 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75219ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/05/2014 SUPPL-13 Labeling-Package Insert

Label is not available on this site.

05/21/2009 SUPPL-12 Labeling

Label is not available on this site.

05/19/2006 SUPPL-10 Labeling

Label is not available on this site.

03/13/2006 SUPPL-9 Labeling

Label is not available on this site.

08/22/2002 SUPPL-7 Labeling

Label is not available on this site.

02/01/2000 SUPPL-6 Manufacturing (CMC)-Facility

Label is not available on this site.

02/01/2000 SUPPL-5 Manufacturing (CMC)-Facility

Label is not available on this site.

12/02/1999 SUPPL-4 Manufacturing (CMC)-Facility

Label is not available on this site.

12/02/1999 SUPPL-3 Manufacturing (CMC)-Facility

Label is not available on this site.

DICLOFENAC POTASSIUM

TABLET;ORAL; 50MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DICLOFENAC POTASSIUM DICLOFENAC POTASSIUM 50MG TABLET;ORAL Prescription No AB 076561 AMICI
DICLOFENAC POTASSIUM DICLOFENAC POTASSIUM 50MG TABLET;ORAL Prescription No AB 075229 CASI PHARMS INC
DICLOFENAC POTASSIUM DICLOFENAC POTASSIUM 50MG TABLET;ORAL Prescription No AB 075463 MYLAN
DICLOFENAC POTASSIUM DICLOFENAC POTASSIUM 50MG TABLET;ORAL Prescription No AB 075219 TEVA

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