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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 216554
Company: AUROBINDO PHARMA

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 None 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
10/31/2023 ORIG-1 Approval STANDARD

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/01/2024 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

AMPICILLIN TRIHYDRATE

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 216554 AUROBINDO PHARMA
AMPICILLIN TRIHYDRATE AMPICILLIN/AMPICILLIN TRIHYDRATE EQ 500MG BASE CAPSULE;ORAL Prescription No AB 064082 SANDOZ
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