Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 085598
Company: WATSON PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TESTOSTERONE ENANTHATE TESTOSTERONE ENANTHATE 200MG/ML INJECTABLE;INJECTION Prescription AO No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/10/1980 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/18/2015 SUPPL-53 Labeling-Package Insert

Label is not available on this site.

04/19/1999 SUPPL-40 Manufacturing (CMC)

Label is not available on this site.

02/19/1999 SUPPL-38 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

02/02/1999 SUPPL-37 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

12/08/1997 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

12/04/1996 SUPPL-35 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

03/30/1993 SUPPL-34 Labeling

Label is not available on this site.

12/11/1991 SUPPL-33 Labeling

Label is not available on this site.

05/15/1991 SUPPL-32 Labeling

Label is not available on this site.

10/12/1990 SUPPL-31 Labeling

Label is not available on this site.

03/12/1990 SUPPL-30 Labeling

Label is not available on this site.

06/30/1994 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

06/30/1994 SUPPL-28 Labeling

Label is not available on this site.

04/30/1986 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

01/28/1985 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

05/19/1982 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

TESTOSTERONE ENANTHATE

INJECTABLE;INJECTION; 200MG/ML
TE Code = AO

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
TESTOSTERONE ENANTHATE TESTOSTERONE ENANTHATE 200MG/ML INJECTABLE;INJECTION Prescription No AO 091120 HIKMA FARMACEUTICA
TESTOSTERONE ENANTHATE TESTOSTERONE ENANTHATE 200MG/ML INJECTABLE;INJECTION Prescription No AO 040575 NEXUS PHARMS
TESTOSTERONE ENANTHATE TESTOSTERONE ENANTHATE 200MG/ML INJECTABLE;INJECTION Prescription No AO 085598 WATSON PHARMS INC

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