Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019687
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.

03/09/1992 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

03/13/1992 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

08/07/1991 SUPPL-8 Labeling

Label is not available on this site.

08/21/1992 SUPPL-6 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

07/18/1990 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

06/10/1991 SUPPL-2 Labeling

Label is not available on this site.

11/27/1989 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

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