The U.S. Food and Drug Administration has approved an Abbreviated New Drug Application (ANDA) identified as ANDA090007 for the generic drug gabapentin.
The approval covers oral capsule formulations of gabapentin in 100 mg, 300 mg, and 400 mg strengths. These products are classified as prescription human drugs.
Approved manufacturers listed in the FDA record are Time Cap Laboratories, Inc., Bi‑Coastal Pharma International LLC, and Marksans Pharma Limited. Multiple National Drug Code (NDC) identifiers are associated with the various strengths and package sizes.
The submission history includes several labeling submissions (submission numbers 4, 6, 8, and 14). All were reviewed with standard priority and received an "AP" (approved) status. Submission dates are recorded as 20 August 2020, with a later entry dated 18 May 2025.
The FDA’s openfda data also notes the pharmacological class of gabapentin as “Decreased Central Nervous System Disorganized Electrical Activity” and confirms the route of administration as oral.
Regulatory UpdatesSep 16, 2026•3 min read
FDA Approves ANDA090007 for Generic Gabapentin Capsules
FDA has approved ANDA090007 for generic gabapentin oral capsules in 100 mg, 300 mg, and 400 mg strengths, manufactured by Time Cap Laboratories, Bi‑Coastal Pharma, and Marksans Pharma.
Compiled by the Pharmacountry team · Source: FDA.gov
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