Drugs@FDA: FDA-Approved Drugs
Company: TEVA
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 | 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 |
---|---|---|---|---|---|---|---|
09/18/2000 | ORIG-1 | Approval |
Letter (PDF)
Review |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/65056ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/065056_amoxicillin_toc.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
05/01/2024 | SUPPL-26 | Labeling-Package Insert |
Label is not available on this site. |
||
01/03/2024 | SUPPL-21 | Labeling-Package Insert |
Label is not available on this site. |
||
10/22/2014 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/02/2013 | SUPPL-17 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/065056s017lbl.pdf | |
02/25/2009 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
08/20/2002 | SUPPL-6 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
08/20/2002 | SUPPL-5 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
06/28/2002 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
10/24/2001 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
05/15/2001 | SUPPL-1 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
05/02/2013 | SUPPL-17 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/065056s017lbl.pdf |
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 |