Details for New Drug Application (NDA): 211821
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The generic ingredient in LAMOTRIGINE is lamotrigine. There are thirty-two drug master file entries for this compound. Fifty-three suppliers are listed for this compound. Additional details are available on the lamotrigine profile page.
Summary for 211821
Tradename: | LAMOTRIGINE |
Applicant: | Alembic |
Ingredient: | lamotrigine |
Patents: | 0 |
Pharmacology for NDA: 211821
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: 211821
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LAMOTRIGINE | lamotrigine | TABLET, EXTENDED RELEASE;ORAL | 211821 | ANDA | Alembic Pharmaceuticals Limited | 46708-417 | 46708-417-30 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-417-30) |
LAMOTRIGINE | lamotrigine | TABLET, EXTENDED RELEASE;ORAL | 211821 | ANDA | Alembic Pharmaceuticals Limited | 46708-417 | 46708-417-91 | 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-417-91) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 200MG | ||||
Approval Date: | Oct 1, 2024 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 250MG | ||||
Approval Date: | Oct 1, 2024 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 300MG | ||||
Approval Date: | Oct 1, 2024 | TE: | AB | RLD: | No |
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