Product Details for NDA 020145
NITRO-DUR (NITROGLYCERIN)
0.1MG/HR
Marketing Status: Prescription
0.2MG/HR
Marketing Status: Prescription
0.3MG/HR
Marketing Status: Prescription
0.4MG/HR
Marketing Status: Prescription
0.6MG/HR
Marketing Status: Prescription
0.8MG/HR
Marketing Status: Prescription
0.1MG/HR
Marketing Status: Prescription
Active Ingredient: NITROGLYCERIN
Proprietary Name: NITRO-DUR
Dosage Form; Route of Administration: FILM, EXTENDED RELEASE; TRANSDERMAL
Strength: 0.1MG/HR
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code:
Application Number: N020145
Product Number: 001
Approval Date: Apr 4, 1995
Applicant Holder Full Name: USPHARMA LTD
Marketing Status: Prescription
Patent and Exclusivity Information
NITRO-DUR (NITROGLYCERIN)
Proprietary Name: NITRO-DUR
Dosage Form; Route of Administration: FILM, EXTENDED RELEASE; TRANSDERMAL
Strength: 0.1MG/HR
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code:
Application Number: N020145
Product Number: 001
Approval Date: Apr 4, 1995
Applicant Holder Full Name: USPHARMA LTD
Marketing Status: Prescription
Patent and Exclusivity Information
0.2MG/HR
Marketing Status: Prescription
Active Ingredient: NITROGLYCERIN
Proprietary Name: NITRO-DUR
Dosage Form; Route of Administration: FILM, EXTENDED RELEASE; TRANSDERMAL
Strength: 0.2MG/HR
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code:
Application Number: N020145
Product Number: 002
Approval Date: Apr 4, 1995
Applicant Holder Full Name: USPHARMA LTD
Marketing Status: Prescription
Patent and Exclusivity Information
NITRO-DUR (NITROGLYCERIN)
Proprietary Name: NITRO-DUR
Dosage Form; Route of Administration: FILM, EXTENDED RELEASE; TRANSDERMAL
Strength: 0.2MG/HR
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code:
Application Number: N020145
Product Number: 002
Approval Date: Apr 4, 1995
Applicant Holder Full Name: USPHARMA LTD
Marketing Status: Prescription
Patent and Exclusivity Information
0.3MG/HR
Marketing Status: Prescription
Active Ingredient: NITROGLYCERIN
Proprietary Name: NITRO-DUR
Dosage Form; Route of Administration: FILM, EXTENDED RELEASE; TRANSDERMAL
Strength: 0.3MG/HR
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code:
Application Number: N020145
Product Number: 003
Approval Date: Apr 4, 1995
Applicant Holder Full Name: USPHARMA LTD
Marketing Status: Prescription
Patent and Exclusivity Information
NITRO-DUR (NITROGLYCERIN)
Proprietary Name: NITRO-DUR
Dosage Form; Route of Administration: FILM, EXTENDED RELEASE; TRANSDERMAL
Strength: 0.3MG/HR
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code:
Application Number: N020145
Product Number: 003
Approval Date: Apr 4, 1995
Applicant Holder Full Name: USPHARMA LTD
Marketing Status: Prescription
Patent and Exclusivity Information
0.4MG/HR
Marketing Status: Prescription
Active Ingredient: NITROGLYCERIN
Proprietary Name: NITRO-DUR
Dosage Form; Route of Administration: FILM, EXTENDED RELEASE; TRANSDERMAL
Strength: 0.4MG/HR
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code:
Application Number: N020145
Product Number: 004
Approval Date: Apr 4, 1995
Applicant Holder Full Name: USPHARMA LTD
Marketing Status: Prescription
Patent and Exclusivity Information
NITRO-DUR (NITROGLYCERIN)
Proprietary Name: NITRO-DUR
Dosage Form; Route of Administration: FILM, EXTENDED RELEASE; TRANSDERMAL
Strength: 0.4MG/HR
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code:
Application Number: N020145
Product Number: 004
Approval Date: Apr 4, 1995
Applicant Holder Full Name: USPHARMA LTD
Marketing Status: Prescription
Patent and Exclusivity Information
0.6MG/HR
Marketing Status: Prescription
Active Ingredient: NITROGLYCERIN
Proprietary Name: NITRO-DUR
Dosage Form; Route of Administration: FILM, EXTENDED RELEASE; TRANSDERMAL
Strength: 0.6MG/HR
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code:
Application Number: N020145
Product Number: 005
Approval Date: Apr 4, 1995
Applicant Holder Full Name: USPHARMA LTD
Marketing Status: Prescription
Patent and Exclusivity Information
NITRO-DUR (NITROGLYCERIN)
Proprietary Name: NITRO-DUR
Dosage Form; Route of Administration: FILM, EXTENDED RELEASE; TRANSDERMAL
Strength: 0.6MG/HR
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code:
Application Number: N020145
Product Number: 005
Approval Date: Apr 4, 1995
Applicant Holder Full Name: USPHARMA LTD
Marketing Status: Prescription
Patent and Exclusivity Information
0.8MG/HR
Marketing Status: Prescription
Active Ingredient: NITROGLYCERIN
Proprietary Name: NITRO-DUR
Dosage Form; Route of Administration: FILM, EXTENDED RELEASE; TRANSDERMAL
Strength: 0.8MG/HR
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code:
Application Number: N020145
Product Number: 006
Approval Date: Apr 4, 1995
Applicant Holder Full Name: USPHARMA LTD
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: NITRO-DUR
Dosage Form; Route of Administration: FILM, EXTENDED RELEASE; TRANSDERMAL
Strength: 0.8MG/HR
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code:
Application Number: N020145
Product Number: 006
Approval Date: Apr 4, 1995
Applicant Holder Full Name: USPHARMA LTD
Marketing Status: Prescription
Patent and Exclusivity Information