Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019687
Company: FERRING
Company: FERRING
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LUTREPULSE KIT | GONADORELIN ACETATE | 0.8MG/VIAL | INJECTABLE;INJECTION | Discontinued | None | No | No |
| LUTREPULSE KIT | GONADORELIN ACETATE | 3.2MG/VIAL | 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 |
|---|---|---|---|---|---|---|---|
| 10/10/1989 | ORIG-1 | Approval | Type 2 - New Active Ingredient | STANDARD; Orphan |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/02/1993 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 04/05/1993 | SUPPL-12 | Labeling |
Label is not available on this site. |
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| 03/09/1992 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 03/13/1992 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 08/07/1991 | SUPPL-8 | Labeling |
Label is not available on this site. |
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| 08/21/1992 | SUPPL-6 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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| 07/18/1990 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/10/1991 | SUPPL-2 | Labeling |
Label is not available on this site. |
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| 11/27/1989 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |