Details for New Drug Application (NDA): 218583
✉ Email this page to a colleague
NDA 218583 describes NITROGLYCERIN, which is a drug marketed by Lannett Co Inc, Mylan Technologies, Zydus Pharms, Abraxis Pharm, Am Regent, Hospira, Intl Medication, Luitpold, Smith And Nephew, Cosette, Encube, Tp Anda Holdings, Fougera Pharms Inc, Padagis Israel, Actavis Labs Fl Inc, Aurobindo Pharma, Dr Reddys, Glenmark Speclt, Mankind Pharma, Natco, Rubicon Research, Sigmapharm Labs Llc, Viwit Pharm, and Baxter Hlthcare, and is included in thirty-five NDAs. It is available from twenty-eight suppliers. Additional details are available on the NITROGLYCERIN profile page.
The generic ingredient in NITROGLYCERIN is nitroglycerin. There are thirty-six drug master file entries for this compound. Thirty-seven suppliers are listed for this compound. Additional details are available on the nitroglycerin profile page.
The generic ingredient in NITROGLYCERIN is nitroglycerin. There are thirty-six drug master file entries for this compound. Thirty-seven suppliers are listed for this compound. Additional details are available on the nitroglycerin profile page.
Summary for 218583
| Tradename: | NITROGLYCERIN |
| Applicant: | Viwit Pharm |
| Ingredient: | nitroglycerin |
| Patents: | 0 |
Pharmacology for NDA: 218583
| Physiological Effect | Vasodilation |
Medical Subject Heading (MeSH) Categories for 218583
Suppliers and Packaging for NDA: 218583
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NITROGLYCERIN | nitroglycerin | TABLET;SUBLINGUAL | 218583 | ANDA | Solco Healthcare U.S., LLC | 43547-985 | 43547-985-04 | 4 BOTTLE in 1 CARTON (43547-985-04) / 25 TABLET in 1 BOTTLE |
| NITROGLYCERIN | nitroglycerin | TABLET;SUBLINGUAL | 218583 | ANDA | Solco Healthcare U.S., LLC | 43547-985 | 43547-985-10 | 1 BOTTLE in 1 CARTON (43547-985-10) / 100 TABLET in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;SUBLINGUAL | Strength | 0.3MG | ||||
| Approval Date: | Oct 15, 2024 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;SUBLINGUAL | Strength | 0.4MG | ||||
| Approval Date: | Oct 15, 2024 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;SUBLINGUAL | Strength | 0.6MG | ||||
| Approval Date: | Oct 15, 2024 | TE: | AB | RLD: | No | ||||
Complete Access Available with Subscription
