Details for New Drug Application (NDA): 209779
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NDA 209779 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, Fougera Pharms Inc, Padagis Israel, Actavis Labs Fl Inc, Aurobindo Pharma, Dr Reddys, Glenmark Pharms Sa, Mankind Pharma, Natco, Rubicon, Sigmapharm Labs Llc, and Baxter Hlthcare, and is included in thirty-one NDAs. It is available from twenty-four 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-three 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-three suppliers are listed for this compound. Additional details are available on the nitroglycerin profile page.
Summary for 209779
| Tradename: | NITROGLYCERIN |
| Applicant: | Rubicon |
| Ingredient: | nitroglycerin |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 209779
| Physiological Effect | Vasodilation |
Medical Subject Heading (MeSH) Categories for 209779
Suppliers and Packaging for NDA: 209779
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NITROGLYCERIN | nitroglycerin | TABLET;SUBLINGUAL | 209779 | ANDA | Advagen Pharma Ltd | 72888-138 | 72888-138-01 | 1 BOTTLE in 1 CARTON (72888-138-01) / 100 TABLET in 1 BOTTLE |
| NITROGLYCERIN | nitroglycerin | TABLET;SUBLINGUAL | 209779 | ANDA | Advagen Pharma Ltd | 72888-139 | 72888-139-01 | 1 BOTTLE in 1 CARTON (72888-139-01) / 100 TABLET in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;SUBLINGUAL | Strength | 0.3MG | ||||
| Approval Date: | May 3, 2021 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;SUBLINGUAL | Strength | 0.4MG | ||||
| Approval Date: | May 3, 2021 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;SUBLINGUAL | Strength | 0.6MG | ||||
| Approval Date: | May 3, 2021 | TE: | AB | RLD: | No | ||||
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