Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078502
Company: CYPRESS PHARM
Company: CYPRESS PHARM
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ELIPHOS | CALCIUM ACETATE | 667MG | 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 |
---|---|---|---|---|---|---|---|
11/24/2008 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/078502Orig1Approv.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
07/12/2012 | SUPPL-6 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
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06/03/2009 | SUPPL-5 | Labeling |
Label is not available on this site. |
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03/18/2009 | SUPPL-4 | Labeling |
Label is not available on this site. |
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03/20/2009 | SUPPL-3 | Labeling |
Label is not available on this site. |
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01/21/2009 | SUPPL-2 | Labeling |
Label is not available on this site. |