CANDESARTAN CILEXETIL | A091390 | ZYDUS LIFESCIENCES LTD
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Attachment 3 - Candesartan Cilexetil PI - HIGHLIGHTS OF PRESCRIBING INFORMATI... FDA-2021-P-0510 Hyman, Phelps & McNamara, P.C. filed a suitability petition regarding candesartan cilexetil, requesting FDA consideration of the drug's suitability for approval under the abbreviated new drug application pathway. The petition references proposed prescribing information highlights for the angiotensin | Suitability | 2021-05-26 | Granted | Hyman, Phelps & McNamara, P.C. |
Attachment 2 - ATACAND PI - ATACAND- candes artan cilexetil tablet RE Suitabi... FDA-2021-P-0510 Hyman, Phelps & McNamara, P.C. filed a suitability petition regarding ATACAND (candesartan cilexetil) tablets, requesting FDA evaluation of the product's suitability for approval or related regulatory action. | Suitability | 2021-05-26 | Granted | Hyman, Phelps & McNamara, P.C. |
Attachment 1 - ATACAND - Prescription Drug Product List RE Suitability Petiti... FDA-2021-P-0510 Hyman, Phelps & McNamara, P.C. filed a suitability petition regarding Atacand (candesartan cilexetil), a prescription drug product, requesting that the FDA determine the suitability of the drug for inclusion on the Prescription Drug Product List. | Suitability | 2021-05-26 | Granted | Hyman, Phelps & McNamara, P.C. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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