Details for New Drug Application (NDA): 217970
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NDA 217970 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 Pharms Nc, Encube, Padagis Israel, Solaris Pharma Corp, Tp Anda Holdings, Fougera Pharms Inc, 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-seven NDAs. It is available from thirty-one suppliers. Additional details are available on the NITROGLYCERIN profile page.
The generic ingredient in NITROGLYCERIN is nitroglycerin. There is one drug master file entry for this compound. Thirty-nine suppliers are listed for this compound. Additional details are available on the nitroglycerin profile page.
The generic ingredient in NITROGLYCERIN is nitroglycerin. There is one drug master file entry for this compound. Thirty-nine suppliers are listed for this compound. Additional details are available on the nitroglycerin profile page.
Summary for 217970
| Tradename: | NITROGLYCERIN |
| Applicant: | Mankind Pharma |
| Ingredient: | nitroglycerin |
| Patents: | 0 |
Pharmacology for NDA: 217970
| Physiological Effect | Vasodilation |
Medical Subject Heading (MeSH) Categories for 217970
Suppliers and Packaging for NDA: 217970
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NITROGLYCERIN | nitroglycerin | TABLET;SUBLINGUAL | 217970 | ANDA | Redpharm Drug | 67296-2313 | 67296-2313-2 | 1 BOTTLE in 1 CARTON (67296-2313-2) / 25 TABLET in 1 BOTTLE |
| NITROGLYCERIN | nitroglycerin | TABLET;SUBLINGUAL | 217970 | ANDA | REMEDYREPACK INC. | 70518-4277 | 70518-4277-0 | 1 BOTTLE in 1 CARTON (70518-4277-0) / 100 TABLET in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;SUBLINGUAL | Strength | 0.3MG | ||||
| Approval Date: | Dec 5, 2023 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;SUBLINGUAL | Strength | 0.4MG | ||||
| Approval Date: | Dec 5, 2023 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;SUBLINGUAL | Strength | 0.6MG | ||||
| Approval Date: | Dec 5, 2023 | TE: | AB | RLD: | No | ||||
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