Details for New Drug Application (NDA): 020215
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The generic ingredient in MONOKET is isosorbide mononitrate. There are thirty-seven drug master file entries for this compound. Twenty-four 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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