MIDODRINE HYDROCHLORIDE | A076577 | MYLAN PHARMACEUTICALS INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Haynes and Boone, LLP FDA-2018-P-1698 Haynes and Boone, LLP filed this citizen petition under Section 505(j)(2)(C) requesting that the FDA determine Midodrine Hydrochloride Oral Solution, 2.5 mg/5 ml, is suitable for submission in an ANDA, with Mylan's Midodrine Hydrochloride Oral Tablets, 5 mg, as the reference listed drug. The petitio | Suitability | 2018-05-02 | Open | Haynes and Boone |
Exhibit 2 - Mylan Midodrine HCl label re Suitability Petition from Haynes and... FDA-2018-P-1698 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 |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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