Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 065119
Company: TEVA
Company: TEVA
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 | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
12/04/2002 | 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 |
---|---|---|---|---|---|
01/03/2024 | SUPPL-31 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
06/17/2020 | SUPPL-26 | Labeling-Package Insert |
Label is not available on this site. |
||
11/20/2012 | SUPPL-20 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/065119s020lbl.pdf | |
11/26/2012 | SUPPL-18 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
06/10/2011 | SUPPL-15 | Labeling |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
11/20/2012 | SUPPL-20 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/065119s020lbl.pdf |
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 |