Product Details for NDA 016911
DELALUTIN (HYDROXYPROGESTERONE CAPROATE)
125MG/ML (125MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
250MG/ML (250MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
125MG/ML (125MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: HYDROXYPROGESTERONE CAPROATE
Proprietary Name: DELALUTIN
Dosage Form; Route of Administration: SOLUTION; INTRAMUSCULAR
Strength: 125MG/ML (125MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N016911
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: BRISTOL MYERS SQUIBB
Marketing Status: Discontinued
Patent and Exclusivity Information
DELALUTIN (HYDROXYPROGESTERONE CAPROATE)
Proprietary Name: DELALUTIN
Dosage Form; Route of Administration: SOLUTION; INTRAMUSCULAR
Strength: 125MG/ML (125MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N016911
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: BRISTOL MYERS SQUIBB
Marketing Status: Discontinued
Patent and Exclusivity Information
250MG/ML (250MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: HYDROXYPROGESTERONE CAPROATE
Proprietary Name: DELALUTIN
Dosage Form; Route of Administration: SOLUTION; INTRAMUSCULAR
Strength: 250MG/ML (250MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N016911
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: BRISTOL MYERS SQUIBB
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: DELALUTIN
Dosage Form; Route of Administration: SOLUTION; INTRAMUSCULAR
Strength: 250MG/ML (250MG/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: N016911
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: BRISTOL MYERS SQUIBB
Marketing Status: Discontinued
Patent and Exclusivity Information