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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020649

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EDEX (ALPROSTADIL)
0.01MG/VIAL
Marketing Status: Prescription
Active Ingredient: ALPROSTADIL
Proprietary Name: EDEX
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 0.01MG/VIAL
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AP
Application Number: N020649
Product Number: 002
Approval Date: Jun 12, 1997
Applicant Holder Full Name: ENDO OPERATIONS LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
EDEX (ALPROSTADIL)
0.01MG/VIAL
Marketing Status: Prescription
Active Ingredient: ALPROSTADIL
Proprietary Name: EDEX
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 0.01MG/VIAL
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N020649
Product Number: 005
Approval Date: Jul 30, 1998
Applicant Holder Full Name: ENDO OPERATIONS LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
EDEX (ALPROSTADIL)
0.02MG/VIAL
Marketing Status: Prescription
Active Ingredient: ALPROSTADIL
Proprietary Name: EDEX
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 0.02MG/VIAL
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N020649
Product Number: 006
Approval Date: Jul 30, 1998
Applicant Holder Full Name: ENDO OPERATIONS LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
EDEX (ALPROSTADIL)
0.02MG/VIAL
Marketing Status: Prescription
Active Ingredient: ALPROSTADIL
Proprietary Name: EDEX
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 0.02MG/VIAL
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AP
Application Number: N020649
Product Number: 003
Approval Date: Jun 12, 1997
Applicant Holder Full Name: ENDO OPERATIONS LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
EDEX (ALPROSTADIL)
0.04MG/VIAL
Marketing Status: Prescription
Active Ingredient: ALPROSTADIL
Proprietary Name: EDEX
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 0.04MG/VIAL
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N020649
Product Number: 004
Approval Date: Jun 12, 1997
Applicant Holder Full Name: ENDO OPERATIONS LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
EDEX (ALPROSTADIL)
0.04MG/VIAL
Marketing Status: Prescription
Active Ingredient: ALPROSTADIL
Proprietary Name: EDEX
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 0.04MG/VIAL
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N020649
Product Number: 007
Approval Date: Jul 30, 1998
Applicant Holder Full Name: ENDO OPERATIONS LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
EDEX (ALPROSTADIL)
0.005MG/VIAL
Marketing Status: Discontinued
Active Ingredient: ALPROSTADIL
Proprietary Name: EDEX
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 0.005MG/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N020649
Product Number: 001
Approval Date: Jun 12, 1997
Applicant Holder Full Name: ENDO OPERATIONS LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information
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