Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 216554
Company: AUROBINDO PHARMA
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 |