Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 062946
Company: TEVA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMOXICILLIN AMOXICILLIN 125MG/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
11/01/1988 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
02/01/2000 SUPPL-9 Labeling

Label is not available on this site.

07/07/1999 SUPPL-7 Labeling

Label is not available on this site.

09/13/1996 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

02/23/1994 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

02/24/1995 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

05/27/1993 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

05/27/1993 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

03/24/1992 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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