Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 013132

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DECA-DURABOLIN (NANDROLONE DECANOATE)
50MG/ML
Marketing Status: Discontinued

Active Ingredient: NANDROLONE DECANOATE
Proprietary Name: DECA-DURABOLIN
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 50MG/ML
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N013132
Product Number: 001
Approval Date: Jun 12, 1986
Applicant Holder Full Name: WOODWARD SPECIALTY LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information

DECA-DURABOLIN (NANDROLONE DECANOATE)
100MG/ML
Marketing Status: Discontinued

Active Ingredient: NANDROLONE DECANOATE
Proprietary Name: DECA-DURABOLIN
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 100MG/ML
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N013132
Product Number: 002
Approval Date: Jun 12, 1986
Applicant Holder Full Name: WOODWARD SPECIALTY LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information

DECA-DURABOLIN (NANDROLONE DECANOATE)
200MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: NANDROLONE DECANOATE
Proprietary Name: DECA-DURABOLIN
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 200MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N013132
Product Number: 003
Approval Date: Jun 12, 1986
Applicant Holder Full Name: WOODWARD SPECIALTY LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information