Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 062883
Company: DAVA PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMPICILLIN TRIHYDRATE AMPICILLIN/AMPICILLIN TRIHYDRATE EQ 250MG BASE CAPSULE;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
02/25/1988 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
07/22/1997 SUPPL-8 Labeling

Label is not available on this site.

07/01/1994 SUPPL-7 Labeling

Label is not available on this site.

03/31/1994 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

03/31/1994 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

01/31/1994 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

04/01/1993 SUPPL-3 Labeling

Label is not available on this site.

11/20/1991 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

11/20/1991 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

AMPICILLIN TRIHYDRATE

CAPSULE;ORAL; EQ 250MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMPICILLIN TRIHYDRATE AMPICILLIN/AMPICILLIN TRIHYDRATE EQ 250MG BASE CAPSULE;ORAL Prescription No AB 062883 DAVA PHARMS INC
AMPICILLIN TRIHYDRATE AMPICILLIN/AMPICILLIN TRIHYDRATE EQ 250MG BASE CAPSULE;ORAL Prescription No AB 064082 SANDOZ

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