Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 065228
Company: SANDOZ
Company: SANDOZ
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
AMOXICILLIN | AMOXICILLIN | 500MG | TABLET;ORAL | Prescription | AB | No | No |
AMOXICILLIN | AMOXICILLIN | 875MG | TABLET;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 |
---|---|---|---|---|---|---|---|
07/13/2005 | 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-20 | Labeling-Package Insert |
Label is not available on this site. |
||
04/25/2024 | SUPPL-19 | Labeling-Package Insert |
Label is not available on this site. |
||
04/25/2024 | SUPPL-17 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
06/03/2020 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
06/03/2020 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
11/25/2014 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
02/22/2013 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
AMOXICILLIN
TABLET;ORAL; 500MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
AMOXICILLIN | AMOXICILLIN | 500MG | TABLET;ORAL | Prescription | No | AB | 065256 | AUROBINDO |
AMOXICILLIN | AMOXICILLIN | 500MG | TABLET;ORAL | Prescription | No | AB | 065228 | SANDOZ |
AMOXICILLIN | AMOXICILLIN | 500MG | TABLET;ORAL | Prescription | No | AB | 065056 | TEVA |
TABLET;ORAL; 875MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
AMOXICILLIN | AMOXICILLIN | 875MG | TABLET;ORAL | Prescription | No | AB | 065256 | AUROBINDO |
AMOXICILLIN | AMOXICILLIN | 875MG | TABLET;ORAL | Prescription | No | AB | 065255 | HIKMA |
AMOXICILLIN | AMOXICILLIN | 875MG | TABLET;ORAL | Prescription | No | AB | 065228 | SANDOZ |
AMOXICILLIN | AMOXICILLIN | 875MG | TABLET;ORAL | Prescription | No | AB | 065056 | TEVA |