Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 064082
Company: SANDOZ
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
AMPICILLIN TRIHYDRATE AMPICILLIN/AMPICILLIN TRIHYDRATE EQ 500MG 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
08/29/1995 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
09/30/2004 SUPPL-8 Labeling

Label is not available on this site.

04/07/1997 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

11/04/1996 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

11/04/1996 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

11/04/1996 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

CAPSULE;ORAL; EQ 500MG 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 500MG BASE CAPSULE;ORAL Prescription No AB 062882 DAVA PHARMS INC
AMPICILLIN TRIHYDRATE AMPICILLIN/AMPICILLIN TRIHYDRATE EQ 500MG BASE CAPSULE;ORAL Prescription No AB 064082 SANDOZ

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English