Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 064081
Company: TEVA

Products on ANDA 064081

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 064081

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.

Labels for ANDA 064081

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