Details for New Drug Application (NDA): 211604
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NDA 211604 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, 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 211604
| Tradename: | NITROGLYCERIN |
| Applicant: | Natco |
| Ingredient: | nitroglycerin |
| Patents: | 0 |
Pharmacology for NDA: 211604
| Physiological Effect | Vasodilation |
Medical Subject Heading (MeSH) Categories for 211604
Suppliers and Packaging for NDA: 211604
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NITROGLYCERIN | nitroglycerin | TABLET;SUBLINGUAL | 211604 | ANDA | NuCare Pharmaceuticals,Inc. | 68071-2941 | 68071-2941-5 | 1 BOTTLE in 1 CARTON (68071-2941-5) / 25 TABLET in 1 BOTTLE |
| NITROGLYCERIN | nitroglycerin | TABLET;SUBLINGUAL | 211604 | ANDA | Natco Pharma USA LLC | 69339-173 | 69339-173-01 | 1 TABLET in 1 CARTON (69339-173-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;SUBLINGUAL | Strength | 0.3MG | ||||
| Approval Date: | Apr 30, 2019 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;SUBLINGUAL | Strength | 0.4MG | ||||
| Approval Date: | Apr 30, 2019 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;SUBLINGUAL | Strength | 0.6MG | ||||
| Approval Date: | Apr 30, 2019 | TE: | AB | RLD: | No | ||||
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