Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020443
Company: EMD SERONO INC
Company: EMD SERONO INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
GEREF | SERMORELIN ACETATE | EQ 0.5MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
GEREF | SERMORELIN ACETATE | EQ 1MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |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 |
---|---|---|---|---|---|---|---|
09/26/1997 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD; Orphan |
Label is not available on this site. |