Details for New Drug Application (NDA): 218879
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NDA 218879 describes SUBVENITE, which is a drug marketed by Owp Pharms and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the SUBVENITE profile page.
The generic ingredient in SUBVENITE is lamotrigine. There are thirty-two drug master file entries for this compound. Fifty-one suppliers are listed for this compound. Additional details are available on the lamotrigine profile page.
The generic ingredient in SUBVENITE is lamotrigine. There are thirty-two drug master file entries for this compound. Fifty-one suppliers are listed for this compound. Additional details are available on the lamotrigine profile page.
Summary for 218879
| Tradename: | SUBVENITE |
| Applicant: | Owp Pharms |
| Ingredient: | lamotrigine |
| Patents: | 2 |
Pharmacology for NDA: 218879
| Mechanism of Action | Dihydrofolate Reductase Inhibitors Organic Cation Transporter 2 Inhibitors |
| Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Suppliers and Packaging for NDA: 218879
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SUBVENITE | lamotrigine | SUSPENSION;ORAL | 218879 | NDA | OWP Pharmaceuticals, Inc. | 69102-418 | 69102-418-01 | 1 BOTTLE in 1 PACKAGE (69102-418-01) / 240 mL in 1 BOTTLE |
| SUBVENITE | lamotrigine | SUSPENSION;ORAL | 218879 | NDA | OWP Pharmaceuticals, Inc. | 69102-418 | 69102-418-02 | 2 BOTTLE in 1 PACKAGE (69102-418-02) / 240 mL in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION;ORAL | Strength | 10MG/ML | ||||
| Approval Date: | Sep 16, 2025 | TE: | RLD: | Yes | |||||
| Patent: | 11,596,634 | Patent Expiration: | May 29, 2040 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | ADJUNCTIVE THERAPY FOR PARTIAL-ONSET, PRIMARY GENERALIZED TONIC-CLONIC (PGTC), OR LENNOX-GASTAUT SEIZURES IN PATIENTS 2 YEARS AND OLDER | ||||||||
| Patent: | 11,596,634 | Patent Expiration: | May 29, 2040 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | CONVERSION TO MONOTHERAPY FOR PARTIAL-ONSET SEIZURES IN PATIENTS 16 YEARS AND OLDER | ||||||||
| Patent: | 11,596,634 | Patent Expiration: | May 29, 2040 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | MAINTENANCE TREATMENT OF BIPOLAR I DISORDER TO DELAY MOOD EPISODES | ||||||||
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