Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 013132
Company: ASPEN GLOBAL INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DECA-DURABOLIN NANDROLONE DECANOATE 50MG/ML INJECTABLE;INJECTION Discontinued None No No
DECA-DURABOLIN NANDROLONE DECANOATE 100MG/ML INJECTABLE;INJECTION Discontinued None No No
DECA-DURABOLIN NANDROLONE DECANOATE 200MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No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
10/05/1962 ORIG-1 Approval Type 2 - New Active Ingredient STANDARD

Label is not available on this site.

Supplements
Action Date Submission Submission Classification Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/20/1999 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

12/23/1997 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

02/18/1994 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

06/16/1987 SUPPL-18 Labeling

Label is not available on this site.

02/10/1987 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

06/12/1986 SUPPL-16 Labeling

Label is not available on this site.

12/05/1984 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

01/07/1987 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

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