Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 060704
Company: IVAX SUB TEVA PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TETRACYCLINE HYDROCHLORIDE TETRACYCLINE HYDROCHLORIDE 250MG CAPSULE;ORAL Discontinued None No No
TETRACYCLINE HYDROCHLORIDE TETRACYCLINE HYDROCHLORIDE 500MG 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
07/05/1963 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/27/2014 SUPPL-35 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/060704s035lbl.pdf
06/12/2002 SUPPL-27 Manufacturing (CMC)-Facility

Label is not available on this site.

09/12/2001 SUPPL-26 Manufacturing (CMC)-Facility

Label is not available on this site.

09/07/2001 SUPPL-25 Manufacturing (CMC)-Facility

Label is not available on this site.

08/04/2000 SUPPL-24 Labeling

Label is not available on this site.

08/04/2000 SUPPL-23 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/30/2000 SUPPL-22 Labeling

Label is not available on this site.

01/28/2000 SUPPL-21 Manufacturing (CMC)-Facility

Label is not available on this site.

03/30/2000 SUPPL-20 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/20/1999 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

07/02/1999 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

07/02/1999 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

07/02/1999 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

07/02/1999 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

07/02/1999 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

12/09/1998 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

05/30/1997 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

06/04/1996 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

01/31/1996 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

01/31/1996 SUPPL-9 Labeling

Label is not available on this site.

01/31/1996 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

04/30/1996 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

09/24/1993 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

09/03/1992 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

09/03/1992 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

05/27/1992 SUPPL-3 Labeling

Label is not available on this site.

06/23/1992 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

08/22/1991 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/27/2014 SUPPL-35 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/060704s035lbl.pdf

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