Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 065334
Company: AUROBINDO
Company: AUROBINDO
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
AMOXICILLIN | AMOXICILLIN | 200MG/5ML | FOR SUSPENSION;ORAL | Prescription | AB | No | No |
AMOXICILLIN | AMOXICILLIN | 400MG/5ML | FOR SUSPENSION;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 |
---|---|---|---|---|---|---|---|
12/28/2006 | 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 |
---|---|---|---|---|---|
05/01/2024 | SUPPL-25 | Labeling-Package Insert |
Label is not available on this site. |
||
04/09/2024 | SUPPL-20 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
04/09/2024 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
04/09/2024 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
04/09/2024 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
12/03/2012 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
11/26/2012 | SUPPL-2 | Labeling |
Label is not available on this site. |
AMOXICILLIN
FOR SUSPENSION;ORAL; 200MG/5ML
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
AMOXICILLIN | AMOXICILLIN | 200MG/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 065334 | AUROBINDO |
AMOXICILLIN | AMOXICILLIN | 200MG/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 065325 | HIKMA |
AMOXICILLIN | AMOXICILLIN | 200MG/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 065378 | SANDOZ |
AMOXICILLIN | AMOXICILLIN | 200MG/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 065119 | TEVA |
FOR SUSPENSION;ORAL; 400MG/5ML
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
AMOXICILLIN | AMOXICILLIN | 400MG/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 065334 | AUROBINDO |
AMOXICILLIN | AMOXICILLIN | 400MG/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 065325 | HIKMA |
AMOXICILLIN | AMOXICILLIN | 400MG/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 065378 | SANDOZ |
AMOXICILLIN | AMOXICILLIN | 400MG/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 065119 | TEVA |
AMOXICILLIN | AMOXICILLIN | 400MG/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 065319 | WOCKHARDT BIO AG |
AMOXIL | AMOXICILLIN | 400MG/5ML | FOR SUSPENSION;ORAL | Prescription | Yes | AB | 050760 | US ANTIBIOTICS |