Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 065189
Company: SANDOZ
Company: SANDOZ
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
AMOXICILLIN AND CLAVULANATE POTASSIUM | AMOXICILLIN; CLAVULANATE POTASSIUM | 250MG;EQ 125MG BASE | TABLET;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 |
---|---|---|---|---|---|---|---|
08/23/2005 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/065189_ORIGINAL APPROVAL_PACKAGE.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
05/01/2024 | SUPPL-30 | Labeling-Package Insert |
Label is not available on this site. |
||
04/29/2024 | SUPPL-28 | Labeling-Package Insert |
Label is not available on this site. |
||
09/22/2014 | SUPPL-16 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
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09/22/2014 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
||
09/22/2014 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
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09/26/2006 | SUPPL-6 | Labeling |
Label is not available on this site. |
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07/31/2006 | SUPPL-4 | Labeling |
Label is not available on this site. |
AMOXICILLIN AND CLAVULANATE POTASSIUM
TABLET;ORAL; 250MG;EQ 125MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
AMOXICILLIN AND CLAVULANATE POTASSIUM | AMOXICILLIN; CLAVULANATE POTASSIUM | 250MG;EQ 125MG BASE | TABLET;ORAL | Prescription | No | AB | 091569 | AUROBINDO PHARMA LTD |
AMOXICILLIN AND CLAVULANATE POTASSIUM | AMOXICILLIN; CLAVULANATE POTASSIUM | 250MG;EQ 125MG BASE | TABLET;ORAL | Prescription | No | AB | 205707 | MICRO LABS LTD INDIA |
AMOXICILLIN AND CLAVULANATE POTASSIUM | AMOXICILLIN; CLAVULANATE POTASSIUM | 250MG;EQ 125MG BASE | TABLET;ORAL | Prescription | No | AB | 065189 | SANDOZ |