Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 064071
Company: SANDOZ
Company: SANDOZ
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PENICILLIN V POTASSIUM | PENICILLIN V POTASSIUM | EQ 250MG BASE | TABLET;ORAL | Discontinued | None | No | No |
PENICILLIN V POTASSIUM | PENICILLIN V POTASSIUM | EQ 500MG BASE | TABLET;ORAL | Discontinued | None | 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 |
---|---|---|---|---|---|---|---|
11/30/1995 | 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 |
---|---|---|---|---|---|
10/28/2010 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
10/11/2012 | SUPPL-6 | Labeling |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/064071s006lbl.pdf | |
09/30/2004 | SUPPL-3 | Labeling |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
10/11/2012 | SUPPL-6 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/064071s006lbl.pdf |