Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 009402

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DELESTROGEN (ESTRADIOL VALERATE)
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: PAR STERILE PRODUCTS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

DELESTROGEN (ESTRADIOL VALERATE)
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: PAR STERILE PRODUCTS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

DELESTROGEN (ESTRADIOL VALERATE)
40MG/ML
Marketing Status: Prescription

Active Ingredient: ESTRADIOL VALERATE
Proprietary Name: DELESTROGEN
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 40MG/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AO
Application Number: N009402
Product Number: 003
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: PAR STERILE PRODUCTS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information