Details for New Drug Application (NDA): 218235
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NDA 218235 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 218235
| Tradename: | NITROGLYCERIN |
| Applicant: | Encube |
| Ingredient: | nitroglycerin |
| Patents: | 0 |
Pharmacology for NDA: 218235
| Physiological Effect | Vasodilation |
Medical Subject Heading (MeSH) Categories for 218235
Suppliers and Packaging for NDA: 218235
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NITROGLYCERIN | nitroglycerin | OINTMENT;TRANSDERMAL | 218235 | ANDA | Encube Ethicals, Inc. | 21922-054 | 21922-054-05 | 1 TUBE in 1 CARTON (21922-054-05) / 30 g in 1 TUBE |
| NITROGLYCERIN | nitroglycerin | OINTMENT;TRANSDERMAL | 218235 | ANDA | Encube Ethicals, Inc. | 21922-054 | 21922-054-47 | 48 POUCH in 1 CARTON (21922-054-47) / 1 g in 1 POUCH (21922-054-59) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | OINTMENT;TRANSDERMAL | Strength | 2% | ||||
| Approval Date: | Apr 15, 2025 | TE: | AB | RLD: | No | ||||
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