Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 201374
Company: ANCHEN PHARMS
Company: ANCHEN PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LAMOTRIGINE | LAMOTRIGINE | 25MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
LAMOTRIGINE | LAMOTRIGINE | 50MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
LAMOTRIGINE | LAMOTRIGINE | 100MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
LAMOTRIGINE | LAMOTRIGINE | 200MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
LAMOTRIGINE | LAMOTRIGINE | 250MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
LAMOTRIGINE | LAMOTRIGINE | 300MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
12/26/2012 | ORIG-1 | Approval |
Review (PDF)
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Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/201374Orig1s000Approv.pdf |