Details for New Drug Application (NDA): 087355
✉ Email this page to a colleague
NDA 087355 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, Solaris Pharma Corp, 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-six NDAs. It is available from thirty 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-eight 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-eight suppliers are listed for this compound. Additional details are available on the nitroglycerin profile page.
Summary for 087355
| Tradename: | NITROGLYCERIN |
| Applicant: | Fougera Pharms Inc |
| Ingredient: | nitroglycerin |
| Patents: | 0 |
Pharmacology for NDA: 087355
| Physiological Effect | Vasodilation |
Medical Subject Heading (MeSH) Categories for 087355
Suppliers and Packaging for NDA: 087355
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NITROGLYCERIN | nitroglycerin | OINTMENT;TRANSDERMAL | 087355 | ANDA | Savage Laboratories a division of Fougera Pharmaceuticals, LLC | 0281-0326 | 0281-0326-08 | 48 PACKET in 1 BOX (0281-0326-08) / 1 g in 1 PACKET |
| NITROGLYCERIN | nitroglycerin | OINTMENT;TRANSDERMAL | 087355 | ANDA | Savage Laboratories a division of Fougera Pharmaceuticals, LLC | 0281-0326 | 0281-0326-30 | 30 g in 1 TUBE (0281-0326-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | OINTMENT;TRANSDERMAL | Strength | 2% | ||||
| Approval Date: | Jul 8, 1988 | TE: | AB | RLD: | Yes | ||||
Complete Access Available with Subscription
