Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 065162
Company: TEVA
Company: TEVA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
AMOXICILLIN AND CLAVULANATE POTASSIUM | AMOXICILLIN; CLAVULANATE POTASSIUM | 600MG/5ML;EQ 42.9MG BASE/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 |
---|---|---|---|---|---|---|---|
03/12/2004 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/065162_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-40 | Labeling, Labeling-Package Insert |
Label is not available on this site. |
||
04/26/2024 | SUPPL-36 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
04/26/2024 | SUPPL-32 | Labeling-Package Insert |
Label is not available on this site. |
||
04/26/2024 | SUPPL-29 | Labeling-Package Insert |
Label is not available on this site. |
||
04/26/2013 | SUPPL-23 | Labeling-Package Insert |
Label is not available on this site. |
||
03/05/2009 | SUPPL-21 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/065162s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/065162s021ltr.pdf | |
09/08/2006 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
10/17/2005 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
02/17/2015 | SUPPL-8 | Labeling |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
03/05/2009 | SUPPL-21 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/065162s021lbl.pdf |
AMOXICILLIN AND CLAVULANATE POTASSIUM
FOR SUSPENSION;ORAL; 600MG/5ML;EQ 42.9MG BASE/5ML
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 | 600MG/5ML;EQ 42.9MG BASE/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 201091 | AUROBINDO PHARMA LTD |
AMOXICILLIN AND CLAVULANATE POTASSIUM | AMOXICILLIN; CLAVULANATE POTASSIUM | 600MG/5ML;EQ 42.9MG BASE/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 209351 | DEVA HOLDING AS |
AMOXICILLIN AND CLAVULANATE POTASSIUM | AMOXICILLIN; CLAVULANATE POTASSIUM | 600MG/5ML;EQ 42.9MG BASE/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 065373 | HIKMA PHARMS |
AMOXICILLIN AND CLAVULANATE POTASSIUM | AMOXICILLIN; CLAVULANATE POTASSIUM | 600MG/5ML;EQ 42.9MG BASE/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 217805 | MICRO LABS |
AMOXICILLIN AND CLAVULANATE POTASSIUM | AMOXICILLIN; CLAVULANATE POTASSIUM | 600MG/5ML;EQ 42.9MG BASE/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 065358 | SANDOZ INC |
AMOXICILLIN AND CLAVULANATE POTASSIUM | AMOXICILLIN; CLAVULANATE POTASSIUM | 600MG/5ML;EQ 42.9MG BASE/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 065162 | TEVA |
AMOXICILLIN AND CLAVULANATE POTASSIUM | AMOXICILLIN; CLAVULANATE POTASSIUM | 600MG/5ML;EQ 42.9MG BASE/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 065420 | WOCKHARDT BIO AG |
AUGMENTIN ES-600 | AMOXICILLIN; CLAVULANATE POTASSIUM | 600MG/5ML;EQ 42.9MG BASE/5ML | FOR SUSPENSION;ORAL | Prescription | Yes | AB | 050755 | US ANTIBIOTICS |