RIZATRIPTAN BENZOATE | N205394 | GENSCO LABORATORIES LLC DBA GENSCO PHARMA
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from IntelGenx Corporation FDA-2013-P-1058 · 4 docket documents IntelGenx Corporation filed this citizen petition in August 2013 requesting that the FDA designate Rizatriptan Oral Film as therapeutically equivalent (AB) to the reference listed drug Maxalt-MLT (rizatriptan benzoate orally disintegrating tablet, NDA 20-865) under section 505(b)(2) of the Federal F | 505(q) | 2013-09-16 | Withdrawn | IntelGenx Corporation |
Source: Regulations.gov. FDA citizen petitions matched by application number.
| Patent # | Expiration | PED | Drug Substance | Drug Product | Use Code | Delist |
|---|---|---|---|---|---|---|
| 9301948 | Jul 30, 2034 | — | Yes | Yes | — | — |