LAMOTRIGINE — FDA application ANDA207497
Listed sponsor: AMNEAL PHARMS · AMRX company profile · exact_unique
Sponsor as listed in Drugs@FDA at retrieval (2026-08-07); FDA sponsor listings can lag ownership transfers.
FDA application facts
| Product | FDA-listed trade name | Active ingredient | Dosage form | Route | Strength | Marketing status | TE code | RLD |
|---|---|---|---|---|---|---|---|---|
| 001 | LAMOTRIGINE | LAMOTRIGINE | TABLET, EXTENDED RELEASE | ORAL | 25MG | Prescription | AB | No |
| 002 | LAMOTRIGINE | LAMOTRIGINE | TABLET, EXTENDED RELEASE | ORAL | 50MG | Prescription | AB | No |
| 003 | LAMOTRIGINE | LAMOTRIGINE | TABLET, EXTENDED RELEASE | ORAL | 100MG | Prescription | AB | No |
| 004 | LAMOTRIGINE | LAMOTRIGINE | TABLET, EXTENDED RELEASE | ORAL | 200MG | Prescription | AB | No |
| 005 | LAMOTRIGINE | LAMOTRIGINE | TABLET, EXTENDED RELEASE | ORAL | 250MG | Prescription | AB | No |
| 006 | LAMOTRIGINE | LAMOTRIGINE | TABLET, EXTENDED RELEASE | ORAL | 300MG | Prescription | AB | No |
Product, form, strength, reference-drug and marketing-status fields: Drugs@FDA data files; TE and RLD fields: Orange Book data files. Retrieved 2026-08-07.
Orange Book patent and exclusivity listings
No Orange Book patent or exclusivity listings joined to this application.
Compound cross-links
- LAMOTRIGINE · UNII U3H27498KS · lmmol compound PYZRQGJRPPTADH-UHFFFAOYSA-N · CHEMBL741
Ingredient–compound links use FDA openFDA/GSRS identifiers and an exact lmmol InChIKey join. Ingredient names cannot create a link.
Related pages
Sponsor company · FDA-approved application index
Peer clusters: No published peer-cluster link for this sponsor.
Sources: Drugs@FDA · Orange Book · openFDA application record. FDA data retrieved 2026-08-07.
Regulatory listing data as published by FDA; not medical or investment advice.