Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 064204
Company: WATSON LABS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CEFACLOR CEFACLOR EQ 125MG BASE/5ML FOR SUSPENSION;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
02/18/1998 ORIG-1 Approval Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/64204ap.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/08/2000 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

05/03/1999 SUPPL-4 Labeling

Label is not available on this site.

03/05/1999 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

02/19/1999 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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