Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 065117
Company: SANDOZ INC
Company: SANDOZ INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
AMOXICILLIN AND CLAVULANATE POTASSIUM | AMOXICILLIN; CLAVULANATE POTASSIUM | 500MG;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 |
---|---|---|---|---|---|---|---|
11/27/2002 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/065117.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
05/01/2024 | SUPPL-34 | Labeling-Package Insert |
Label is not available on this site. |
||
02/23/2023 | SUPPL-33 | Labeling-Package Insert |
Label is not available on this site. |
||
09/25/2014 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
||
05/20/2010 | SUPPL-13 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
09/29/2009 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
07/31/2006 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
09/01/2005 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
03/26/2004 | SUPPL-2 | Labeling |
Label is not available on this site. |
AMOXICILLIN AND CLAVULANATE POTASSIUM
TABLET;ORAL; 500MG;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 | 500MG;EQ 125MG BASE | TABLET;ORAL | Prescription | No | AB | 091569 | AUROBINDO PHARMA LTD |
AMOXICILLIN AND CLAVULANATE POTASSIUM | AMOXICILLIN; CLAVULANATE POTASSIUM | 500MG;EQ 125MG BASE | TABLET;ORAL | Prescription | No | AB | 209992 | DEVA HOLDING AS |
AMOXICILLIN AND CLAVULANATE POTASSIUM | AMOXICILLIN; CLAVULANATE POTASSIUM | 500MG;EQ 125MG BASE | TABLET;ORAL | Prescription | No | AB | 205707 | MICRO LABS LTD INDIA |
AMOXICILLIN AND CLAVULANATE POTASSIUM | AMOXICILLIN; CLAVULANATE POTASSIUM | 500MG;EQ 125MG BASE | TABLET;ORAL | Prescription | No | AB | 065064 | SANDOZ |
AMOXICILLIN AND CLAVULANATE POTASSIUM | AMOXICILLIN; CLAVULANATE POTASSIUM | 500MG;EQ 125MG BASE | TABLET;ORAL | Prescription | No | AB | 065117 | SANDOZ INC |
AMOXICILLIN AND CLAVULANATE POTASSIUM | AMOXICILLIN; CLAVULANATE POTASSIUM | 500MG;EQ 125MG BASE | TABLET;ORAL | Prescription | No | AB | 065101 | TEVA |