Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019836
Company: SHIRE
Company: SHIRE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SUPPRELIN | HISTRELIN ACETATE | EQ 0.2MG BASE/ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| SUPPRELIN | HISTRELIN ACETATE | EQ 0.5MG BASE/ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| SUPPRELIN | HISTRELIN ACETATE | EQ 1MG BASE/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 |
|---|---|---|---|---|---|---|---|
| 12/24/1991 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/23/1997 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/17/1997 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/11/1997 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |