Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 064081
Company: TEVA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CEFACLOR CEFACLOR EQ 250MG BASE CAPSULE;ORAL Discontinued None No No
CEFACLOR CEFACLOR EQ 500MG BASE CAPSULE;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
09/16/1996 ORIG-1 Approval Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/64081_Cefaclor_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/64081_Cefaclor_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/64081_Cefaclor.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/25/1999 SUPPL-5 Labeling

Label is not available on this site.

10/28/1998 SUPPL-4 Labeling

Label is not available on this site.

12/10/1997 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

01/10/1997 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

01/10/1997 SUPPL-1 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
09/16/1996 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/64081_Cefaclor_prntlbl.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