MIDODRINE HYDROCHLORIDE | A076449 | IMPAX PHARMACEUTICALS
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Exhibit 2 - Mylan Midodrine HCl label re Suitability Petition from Haynes and... FDA-2018-P-1698 · 7 docket documents Haynes and Boone LLP filed a petition regarding Mylan's midodrine hydrochloride product, requesting FDA action on labeling suitability for the drug. The petition addresses regulatory concerns related to the product's approved labeling and seeks FDA review under established mechanisms governing gener | Suitability | 2018-05-02 | Open | Haynes and Boone LLP |
Custo Pharm Inc - Citizen Petiton FDA-2013-P-0027 · 4 docket documents Custo Pharm Inc filed this citizen petition requesting that the FDA amend the Orange Book to designate Impax Pharmaceutical's Midodrine Hydrochloride Tablets, ANDA 076449, as the reference listed drug for midodrine hydrochloride tablets 5 mg, since the previous reference listed drug Proamatine (NDA | 505(q) | 2013-01-03 | Withdrawn | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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