Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 065021
Company: SUN PHARM INDS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMOXICILLIN AMOXICILLIN 125MG TABLET, CHEWABLE;ORAL Discontinued None No No
AMOXICILLIN AMOXICILLIN 250MG TABLET, CHEWABLE;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
12/23/1999 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/65021ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/30/2008 SUPPL-16 Labeling

Label is not available on this site.

07/31/2006 SUPPL-14 Labeling

Label is not available on this site.

05/04/2006 SUPPL-13 Labeling

Label is not available on this site.

04/07/2006 SUPPL-11 Labeling

Label is not available on this site.

11/29/2005 SUPPL-10 Labeling

Label is not available on this site.

04/23/2004 SUPPL-5 Labeling

Label is not available on this site.

09/29/2003 SUPPL-4 Labeling

Label is not available on this site.

12/22/2000 SUPPL-2 Labeling

Label is not available on this site.

06/29/2000 SUPPL-1 Manufacturing (CMC)-Packaging

Label is not available on this site.

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