CANDESARTAN CILEXETIL | A078702 | MYLAN PHARMACEUTICALS INC
| 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.
Highest NADAC/Unit
$0.5617
per ea
Lowest NADAC/Unit
$0.4980
per ea
Brand NDCs
0
Generic NDCs
8
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00378322477CANDESARTAN CILEXETIL 4 MG TAB | $0.5617 | EA | Generic | — | 2026-10-21 |
| 00378322493CANDESARTAN CILEXETIL 4 MG TAB | $0.5617 | EA | Generic | — | 2026-10-21 |
| 00378323293CANDESARTAN CILEXETIL 32 MG TB | $0.5530 | EA | Generic | — | 2026-10-21 |
| 00378323277CANDESARTAN CILEXETIL 32 MG TB | $0.5530 | EA | Generic | — | 2026-10-21 |
| 00378322577CANDESARTAN CILEXETIL 8 MG TAB | $0.5246 | EA | Generic | — | 2026-10-21 |
| 00378322593CANDESARTAN CILEXETIL 8 MG TAB | $0.5246 | EA | Generic | — | 2026-10-21 |
| 00378323177CANDESARTAN CILEXETIL 16 MG TB | $0.4980 | EA | Generic | — | 2026-10-21 |
| 00378323193CANDESARTAN CILEXETIL 16 MG TB | $0.4980 | EA | Generic | — | 2026-10-21 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.