Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 060456
Company: TEVA
Company: TEVA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PENICILLIN-VK | PENICILLIN V POTASSIUM | EQ 125MG BASE/5ML | FOR SOLUTION;ORAL | Prescription | None | No | No |
| PENICILLIN-VK | PENICILLIN V POTASSIUM | EQ 250MG BASE/5ML | FOR SOLUTION;ORAL | Prescription | None | 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 |
|---|---|---|---|---|---|---|---|
| 07/31/1968 | 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 |
|---|---|---|---|---|---|
| 07/16/2014 | SUPPL-52 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/30/2008 | SUPPL-48 | Labeling |
Label is not available on this site. |
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| 05/31/2007 | SUPPL-46 | Labeling |
Label is not available on this site. |
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| 10/30/2001 | SUPPL-42 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 07/27/2001 | SUPPL-41 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 05/15/2001 | SUPPL-40 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 07/07/2000 | SUPPL-39 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 08/19/1997 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/30/1996 | SUPPL-37 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/27/1996 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/24/1996 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/14/1995 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/22/1994 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/02/1994 | SUPPL-32 | Labeling |
Label is not available on this site. |
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| 08/25/1993 | SUPPL-31 | Labeling |
Label is not available on this site. |
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| 02/26/1993 | SUPPL-30 | Labeling |
Label is not available on this site. |
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| 11/10/1988 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |