Details for New Drug Application (NDA): 020215
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NDA 020215 describes MONOKET, which is a drug marketed by Omnivium Pharms and is included in one NDA. It is available from three suppliers. Additional details are available on the MONOKET profile page.
The generic ingredient in MONOKET is isosorbide mononitrate. There are thirty-seven drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the isosorbide mononitrate profile page.
The generic ingredient in MONOKET is isosorbide mononitrate. There are thirty-seven drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the isosorbide mononitrate profile page.
Summary for 020215
| Tradename: | MONOKET |
| Applicant: | Omnivium Pharms |
| Ingredient: | isosorbide mononitrate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 020215
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MONOKET | isosorbide mononitrate | TABLET;ORAL | 020215 | NDA AUTHORIZED GENERIC | Lannett Company, Inc. | 62175-106 | 62175-106-01 | 100 TABLET in 1 BOTTLE (62175-106-01) |
| MONOKET | isosorbide mononitrate | TABLET;ORAL | 020215 | NDA AUTHORIZED GENERIC | Lannett Company, Inc. | 62175-107 | 62175-107-01 | 100 TABLET in 1 BOTTLE (62175-107-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 20MG | ||||
| Approval Date: | Jun 30, 1993 | TE: | AB | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | Jun 30, 1993 | TE: | AB | RLD: | Yes | ||||
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