Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 065259
Company: LUPIN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CEFDINIR CEFDINIR 125MG/5ML FOR SUSPENSION;ORAL Prescription AB No No
CEFDINIR CEFDINIR 250MG/5ML FOR SUSPENSION;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
05/31/2006 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/065259s000LTR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/01/2010 SUPPL-13 Labeling

Label is not available on this site.

06/11/2008 SUPPL-6 Labeling

Label is not available on this site.

12/13/2007 SUPPL-5 Labeling

Label is not available on this site.

09/11/2007 SUPPL-4 Labeling

Label is not available on this site.

05/07/2007 SUPPL-2 Labeling

Label is not available on this site.

05/07/2007 SUPPL-1 Manufacturing (CMC)-New Strength

Label is not available on this site.

CEFDINIR

FOR SUSPENSION;ORAL; 125MG/5ML
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CEFDINIR CEFDINIR 125MG/5ML FOR SUSPENSION;ORAL Prescription No AB 065473 AUROBINDO PHARMA
CEFDINIR CEFDINIR 125MG/5ML FOR SUSPENSION;ORAL Prescription No AB 065259 LUPIN
CEFDINIR CEFDINIR 125MG/5ML FOR SUSPENSION;ORAL Prescription No AB 065429 ORCHID HLTHCARE
CEFDINIR CEFDINIR 125MG/5ML FOR SUSPENSION;ORAL Prescription No AB 065337 SANDOZ
CEFDINIR CEFDINIR 125MG/5ML FOR SUSPENSION;ORAL Prescription No AB 065332 TEVA PHARMS

FOR SUSPENSION;ORAL; 250MG/5ML
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CEFDINIR CEFDINIR 250MG/5ML FOR SUSPENSION;ORAL Prescription No AB 065473 AUROBINDO PHARMA
CEFDINIR CEFDINIR 250MG/5ML FOR SUSPENSION;ORAL Prescription No AB 065259 LUPIN
CEFDINIR CEFDINIR 250MG/5ML FOR SUSPENSION;ORAL Prescription No AB 065429 ORCHID HLTHCARE
CEFDINIR CEFDINIR 250MG/5ML FOR SUSPENSION;ORAL Prescription No AB 065337 SANDOZ
CEFDINIR CEFDINIR 250MG/5ML FOR SUSPENSION;ORAL Prescription No AB 065332 TEVA PHARMS

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