Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 065256
Company: AUROBINDO
Company: AUROBINDO
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 |
---|---|---|---|---|---|---|---|
11/09/2005 | 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 |
---|---|---|---|---|---|
04/11/2024 | SUPPL-21 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
04/11/2024 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
||
04/11/2024 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
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04/11/2024 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
02/21/2013 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
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03/31/2009 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
10/28/2008 | SUPPL-3 | Labeling |
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 |