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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 004056

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STILBESTROL (DIETHYLSTILBESTROL)
0.2MG/ML
Marketing Status: Discontinued
Active Ingredient: DIETHYLSTILBESTROL
Proprietary Name: STILBESTROL
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 0.2MG/ML
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N004056
Product Number: 003
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: BRISTOL MYERS SQUIBB
Marketing Status:  Discontinued
Patent and Exclusivity Information
STILBESTROL (DIETHYLSTILBESTROL)
0.5MG/ML
Marketing Status: Discontinued
Active Ingredient: DIETHYLSTILBESTROL
Proprietary Name: STILBESTROL
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 0.5MG/ML
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N004056
Product Number: 004
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: BRISTOL MYERS SQUIBB
Marketing Status:  Discontinued
Patent and Exclusivity Information
STILBESTROL (DIETHYLSTILBESTROL)
1MG/ML
Marketing Status: Discontinued
Active Ingredient: DIETHYLSTILBESTROL
Proprietary Name: STILBESTROL
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 1MG/ML
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N004056
Product Number: 005
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: BRISTOL MYERS SQUIBB
Marketing Status:  Discontinued
Patent and Exclusivity Information
STILBESTROL (DIETHYLSTILBESTROL)
5MG/ML
Marketing Status: Discontinued
Active Ingredient: DIETHYLSTILBESTROL
Proprietary Name: STILBESTROL
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 5MG/ML
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N004056
Product Number: 006
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: BRISTOL MYERS SQUIBB
Marketing Status:  Discontinued
Patent and Exclusivity Information
STILBESTROL (DIETHYLSTILBESTROL)
0.1MG
Marketing Status: Discontinued
Active Ingredient: DIETHYLSTILBESTROL
Proprietary Name: STILBESTROL
Dosage Form; Route of Administration: SUPPOSITORY; VAGINAL
Strength: 0.1MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N004056
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
STILBESTROL (DIETHYLSTILBESTROL)
0.5MG
Marketing Status: Discontinued
Active Ingredient: DIETHYLSTILBESTROL
Proprietary Name: STILBESTROL
Dosage Form; Route of Administration: SUPPOSITORY; VAGINAL
Strength: 0.5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N004056
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
STILBETIN (DIETHYLSTILBESTROL)
0.1MG
Marketing Status: Discontinued
Active Ingredient: DIETHYLSTILBESTROL
Proprietary Name: STILBETIN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 0.1MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N004056
Product Number: 007
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: BRISTOL MYERS SQUIBB
Marketing Status:  Discontinued
Patent and Exclusivity Information
STILBETIN (DIETHYLSTILBESTROL)
0.25MG
Marketing Status: Discontinued
Active Ingredient: DIETHYLSTILBESTROL
Proprietary Name: STILBETIN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 0.25MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N004056
Product Number: 017
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: BRISTOL MYERS SQUIBB
Marketing Status:  Discontinued
Patent and Exclusivity Information
STILBETIN (DIETHYLSTILBESTROL)
0.5MG
Marketing Status: Discontinued
Active Ingredient: DIETHYLSTILBESTROL
Proprietary Name: STILBETIN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 0.5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N004056
Product Number: 008
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: BRISTOL MYERS SQUIBB
Marketing Status:  Discontinued
Patent and Exclusivity Information
STILBETIN (DIETHYLSTILBESTROL)
1MG
Marketing Status: Discontinued
Active Ingredient: DIETHYLSTILBESTROL
Proprietary Name: STILBETIN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 1MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N004056
Product Number: 009
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: BRISTOL MYERS SQUIBB
Marketing Status:  Discontinued
Patent and Exclusivity Information
STILBETIN (DIETHYLSTILBESTROL)
5MG
Marketing Status: Discontinued
Active Ingredient: DIETHYLSTILBESTROL
Proprietary Name: STILBETIN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N004056
Product Number: 010
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: BRISTOL MYERS SQUIBB
Marketing Status:  Discontinued
Patent and Exclusivity Information
STILBETIN (DIETHYLSTILBESTROL)
0.1MG
Marketing Status: Discontinued
Active Ingredient: DIETHYLSTILBESTROL
Proprietary Name: STILBETIN
Dosage Form; Route of Administration: TABLET, DELAYED RELEASE; ORAL
Strength: 0.1MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N004056
Product Number: 011
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: BRISTOL MYERS SQUIBB
Marketing Status:  Discontinued
Patent and Exclusivity Information
STILBETIN (DIETHYLSTILBESTROL)
0.5MG
Marketing Status: Discontinued
Active Ingredient: DIETHYLSTILBESTROL
Proprietary Name: STILBETIN
Dosage Form; Route of Administration: TABLET, DELAYED RELEASE; ORAL
Strength: 0.5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N004056
Product Number: 012
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: BRISTOL MYERS SQUIBB
Marketing Status:  Discontinued
Patent and Exclusivity Information
STILBETIN (DIETHYLSTILBESTROL)
1MG
Marketing Status: Discontinued
Active Ingredient: DIETHYLSTILBESTROL
Proprietary Name: STILBETIN
Dosage Form; Route of Administration: TABLET, DELAYED RELEASE; ORAL
Strength: 1MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N004056
Product Number: 013
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: BRISTOL MYERS SQUIBB
Marketing Status:  Discontinued
Patent and Exclusivity Information
STILBETIN (DIETHYLSTILBESTROL)
5MG
Marketing Status: Discontinued
Active Ingredient: DIETHYLSTILBESTROL
Proprietary Name: STILBETIN
Dosage Form; Route of Administration: TABLET, DELAYED RELEASE; ORAL
Strength: 5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N004056
Product Number: 014
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: BRISTOL MYERS SQUIBB
Marketing Status:  Discontinued
Patent and Exclusivity Information
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