Details for New Drug Application (NDA): 216103
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NDA 216103 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 Speclt, Mankind Pharma, Natco, Rubicon, Sigmapharm Labs Llc, Viwit Pharm, and Baxter Hlthcare, and is included in thirty-two 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-five 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-five suppliers are listed for this compound. Additional details are available on the nitroglycerin profile page.
Summary for 216103
| Tradename: | NITROGLYCERIN |
| Applicant: | Cosette |
| Ingredient: | nitroglycerin |
| Patents: | 0 |
Pharmacology for NDA: 216103
| Physiological Effect | Vasodilation |
Medical Subject Heading (MeSH) Categories for 216103
Suppliers and Packaging for NDA: 216103
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NITROGLYCERIN | nitroglycerin | OINTMENT;INTRA-ANAL | 216103 | ANDA | Cosette Pharmaceuticals, Inc. | 0713-0564 | 0713-0564-31 | 1 TUBE in 1 CARTON (0713-0564-31) / 30 g in 1 TUBE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | OINTMENT;INTRA-ANAL | Strength | 0.4% | ||||
| Approval Date: | Feb 16, 2024 | TE: | AB | RLD: | No | ||||
| Regulatory Exclusivity Expiration: | Aug 21, 2024 | ||||||||
| Regulatory Exclusivity Use: | COMPETITIVE GENERIC THERAPY | ||||||||
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