Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076207
Company: FRESENIUS KABI USA
Company: FRESENIUS KABI USA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PAMIDRONATE DISODIUM | PAMIDRONATE DISODIUM | 30MG/10ML (3MG/ML) | INJECTABLE;INJECTION | Discontinued | None | No | No |
| PAMIDRONATE DISODIUM | PAMIDRONATE DISODIUM | 90MG/10ML (9MG/ML) | INJECTABLE;INJECTION | 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 |
|---|---|---|---|---|---|---|---|
| 05/17/2002 | 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 |
|---|---|---|---|---|---|
| 07/02/2015 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/21/2012 | SUPPL-11 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
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| 09/18/2008 | SUPPL-7 | Labeling |
Label is not available on this site. |
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| 02/23/2007 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 11/29/2005 | SUPPL-4 | Labeling |
Label is not available on this site. |
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| 01/21/2005 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 02/13/2004 | SUPPL-1 | Labeling |
Label is not available on this site. |