Manages anxiety disorders. ANDA 90122, held by Alembic Pharms Ltd. Meprobamate.
As of Nov 14, 2026, ANDA 90122 (Meprobamate), held by Alembic Pharms Ltd, was first approved by FDA on Feb 18, 2009, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Meprobamate tablets are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually do not require treatment with an anxiolytic. The effectiveness of meprobamate tablets in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 18, 2009 | Original application | Approved | None posted |
| Meprobamate200MG · tablet;oral | Meprobamate | Rx |
| Meprobamate400MG · tablet;oral | Meprobamate | Rx |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
