Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021134

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NITROSTAT (NITROGLYCERIN)
0.3MG
Marketing Status: Prescription

Active Ingredient: NITROGLYCERIN
Proprietary Name: NITROSTAT
Dosage Form; Route of Administration: TABLET; SUBLINGUAL
Strength: 0.3MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021134
Product Number: 001
Approval Date: May 1, 2000
Applicant Holder Full Name: VIATRIS SPECIALTY LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

NITROSTAT (NITROGLYCERIN)
0.4MG
Marketing Status: Prescription

Active Ingredient: NITROGLYCERIN
Proprietary Name: NITROSTAT
Dosage Form; Route of Administration: TABLET; SUBLINGUAL
Strength: 0.4MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021134
Product Number: 002
Approval Date: May 1, 2000
Applicant Holder Full Name: VIATRIS SPECIALTY LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

NITROSTAT (NITROGLYCERIN)
0.6MG
Marketing Status: Prescription

Active Ingredient: NITROGLYCERIN
Proprietary Name: NITROSTAT
Dosage Form; Route of Administration: TABLET; SUBLINGUAL
Strength: 0.6MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N021134
Product Number: 003
Approval Date: May 1, 2000
Applicant Holder Full Name: VIATRIS SPECIALTY LLC
Marketing Status:  Prescription
Patent and Exclusivity Information