LOPERAMIDE HYDROCHLORIDE | A072741 | MYLAN PHARMACEUTICALS INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from HYMAN, PHELPS & MCNAMARA, P.C. FDA-2023-P-4873 · 7 docket documents The law firm Hyman, Phelps & McNamara, P.C. filed a suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA declare Loperamide HCl Capsules in 1 mg and 4 mg strengths suitable for submission as an Abbreviated New Drug Application, with Johns | Suitability | 2023-11-03 | Denied | HYMAN, PHELPS & MCNAMARA, P.C. |
Suitability Petition from Hyman, Phelps & McNamara, PC FDA-2020-P-1730 · 6 docket documents The law firm Hyman, Phelps & McNamara, P.C., filed this suitability petition on behalf of a client pursuant to Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act and 21 C.F.R. § 314.93, requesting that FDA declare Loperamide HCl Capsules in 1 mg and 4 mg strengths suitable for submissio | Suitability | 2020-08-04 | Denied | Hyman, Phelps & McNamara, PC |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$0.0541
per ea
Lowest NADAC/Unit
$0.0541
per ea
Brand NDCs
0
Generic NDCs
3
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 51079069020LOPERAMIDE 2 MG CAPSULE | $0.0541 | EA | Generic | — | 2026-06-17 |
| 00378210001LOPERAMIDE 2 MG CAPSULE | $0.0541 | EA | Generic | — | 2026-06-17 |
| 00378210005LOPERAMIDE 2 MG CAPSULE | $0.0541 | EA | Generic | — | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.