Details for New Drug Application (NDA): 203934
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The generic ingredient in GABAPENTIN is gabapentin. There are twenty-nine drug master file entries for this compound. Seventy-six suppliers are listed for this compound. Additional details are available on the gabapentin profile page.
Summary for 203934
Tradename: | GABAPENTIN |
Applicant: | Zydus Pharms |
Ingredient: | gabapentin |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 203934
Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Suppliers and Packaging for NDA: 203934
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
GABAPENTIN | gabapentin | TABLET;ORAL | 203934 | ANDA | Zydus Pharmaceuticals USA Inc. | 68382-607 | 68382-607-05 | 500 TABLET in 1 BOTTLE (68382-607-05) |
GABAPENTIN | gabapentin | TABLET;ORAL | 203934 | ANDA | Zydus Pharmaceuticals USA Inc. | 68382-607 | 68382-607-16 | 90 TABLET in 1 BOTTLE (68382-607-16) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 300MG | ||||
Approval Date: | Jan 24, 2024 | TE: | AB2 | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 600MG | ||||
Approval Date: | Jan 24, 2024 | TE: | AB2 | RLD: | No |
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