Product Details for NDA 009402
DELESTROGEN (ESTRADIOL VALERATE)
10MG/ML
Marketing Status: Prescription
20MG/ML
Marketing Status: Prescription
40MG/ML
Marketing Status: Discontinued
10MG/ML
Marketing Status: Prescription
Active Ingredient: ESTRADIOL VALERATE
Proprietary Name: DELESTROGEN
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 10MG/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AO
Application Number: N009402
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: ENDO OPERATIONS LTD
Marketing Status: Prescription
Patent and Exclusivity Information
DELESTROGEN (ESTRADIOL VALERATE)
Proprietary Name: DELESTROGEN
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 10MG/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AO
Application Number: N009402
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: ENDO OPERATIONS LTD
Marketing Status: Prescription
Patent and Exclusivity Information
20MG/ML
Marketing Status: Prescription
Active Ingredient: ESTRADIOL VALERATE
Proprietary Name: DELESTROGEN
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 20MG/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AO
Application Number: N009402
Product Number: 004
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: ENDO OPERATIONS LTD
Marketing Status: Prescription
Patent and Exclusivity Information
DELESTROGEN (ESTRADIOL VALERATE)
Proprietary Name: DELESTROGEN
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 20MG/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AO
Application Number: N009402
Product Number: 004
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: ENDO OPERATIONS LTD
Marketing Status: Prescription
Patent and Exclusivity Information
40MG/ML
Marketing Status: Discontinued
Active Ingredient: ESTRADIOL VALERATE
Proprietary Name: DELESTROGEN
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 40MG/ML
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N009402
Product Number: 003
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: ENDO OPERATIONS LTD
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: DELESTROGEN
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 40MG/ML
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N009402
Product Number: 003
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: ENDO OPERATIONS LTD
Marketing Status: Discontinued
Patent and Exclusivity Information