Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017055
Company: FERRING
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
A.P.L. GONADOTROPIN, CHORIONIC 5,000 UNITS/VIAL INJECTABLE;INJECTION Discontinued None No No
A.P.L. GONADOTROPIN, CHORIONIC 10,000 UNITS/VIAL INJECTABLE;INJECTION Discontinued None No No
A.P.L. GONADOTROPIN, CHORIONIC 20,000 UNITS/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
12/13/1974 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/23/1998 SUPPL-12 Labeling

Label is not available on this site.

05/02/1994 SUPPL-11 Labeling

Label is not available on this site.

08/13/1991 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

12/06/1989 SUPPL-9 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/07/1990 SUPPL-8 Labeling

Label is not available on this site.

04/17/1989 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

11/18/1988 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

02/24/1988 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

09/22/1982 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

02/03/1982 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

06/30/1975 SUPPL-1 Labeling

Label is not available on this site.

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