CANDESARTAN CILEXETIL | N020838 | ANI PHARMACEUTICALS INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Hyman, Phelps & McNamara, P.C. FDA-2021-P-0510 The law firm Hyman, Phelps & McNamara filed a suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act and 21 C.F.R. § 314.93 on behalf of a client requesting that FDA declare Candesartan Cilexetil Tablets, 2 mg, suitable for submission as an ANDA, with ANI Pharmace | Suitability | 2021-05-26 | Open | Hyman |
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 | Open | Hyman |
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 | Open | Hyman |
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 | Open | Hyman |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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