Details for New Drug Application (NDA): 021134
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The generic ingredient in NITROSTAT is nitroglycerin. There are thirty-six drug master file entries for this compound. Thirty-three suppliers are listed for this compound. Additional details are available on the nitroglycerin profile page.
Summary for 021134
Tradename: | NITROSTAT |
Applicant: | Viatris |
Ingredient: | nitroglycerin |
Patents: | 0 |
Pharmacology for NDA: 021134
Physiological Effect | Vasodilation |
Medical Subject Heading (MeSH) Categories for 021134
Suppliers and Packaging for NDA: 021134
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
NITROSTAT | nitroglycerin | TABLET;SUBLINGUAL | 021134 | NDA | Parke-Davis Div of Pfizer Inc | 0071-0417 | 0071-0417-24 | 1 BOTTLE in 1 CARTON (0071-0417-24) / 100 TABLET in 1 BOTTLE |
NITROSTAT | nitroglycerin | TABLET;SUBLINGUAL | 021134 | NDA | Parke-Davis Div of Pfizer Inc | 0071-0418 | 0071-0418-13 | 4 BOTTLE in 1 CARTON (0071-0418-13) / 25 TABLET in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;SUBLINGUAL | Strength | 0.3MG | ||||
Approval Date: | May 1, 2000 | TE: | AB | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;SUBLINGUAL | Strength | 0.4MG | ||||
Approval Date: | May 1, 2000 | TE: | AB | RLD: | Yes |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;SUBLINGUAL | Strength | 0.6MG | ||||
Approval Date: | May 1, 2000 | TE: | AB | RLD: | Yes |
Expired US Patents for NDA 021134
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Viatris | NITROSTAT | nitroglycerin | TABLET;SUBLINGUAL | 021134-001 | May 1, 2000 | ⤷ Sign Up | ⤷ Sign Up |
Viatris | NITROSTAT | nitroglycerin | TABLET;SUBLINGUAL | 021134-003 | May 1, 2000 | ⤷ Sign Up | ⤷ Sign Up |
Viatris | NITROSTAT | nitroglycerin | TABLET;SUBLINGUAL | 021134-002 | May 1, 2000 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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