DIPHENHYDRAMINE HYDROCHLORIDE | A080817 | WEST-WARD PHARMACEUTICALS INTERNATIONAL LTD
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Hyman, Phelps & MCNamara, P.C. FDA-2023-P-4371 · 8 docket documents Law firm Hyman, Phelps & McNamara, P.C., on behalf of a client, filed this suitability petition pursuant to Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that FDA declare Diphenhydramine Hydrochloride Injection in a new 500 mg/10 mL strength suitable for submission as a | Suitability | 2023-10-06 | Denied | Hyman, Phelps & MCNamara, P.C. |
Suitability Petition from Hyman, Phelps & McNamara, P.C. FDA-2023-P-2289 · 7 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that the FDA declare Diphenhydramine Hydrochloride Injection, 500 mg/10 mL (50 mg/mL), su | Suitability | 2023-06-07 | Withdrawn | Hyman, Phelps & McNamara, P.C. |
Emcure Pharmaceuticals USA Inc. - Citizen Petition FDA-2013-P-0336 · 3 docket documents Emcure Pharmaceuticals USA Inc. filed this petition requesting that the FDA accept Abbreviated New Drug Applications (ANDAs) for Diphenhydramine Hydrochloride Injection USP, 50 mg/mL in single-dose vial and multi-dose vial formulations. The petitioner seeks approval to reference the discontinued Ben | Other | 2013-04-04 | Withdrawn | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$0.9399
per ml
Lowest NADAC/Unit
$0.9399
per ml
Brand NDCs
0
Generic NDCs
2
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00641628225DIPHENHYDRAMINE 50 MG/ML VIAL | $0.9399 | ML | Generic | — | 2026-06-17 |
| 00641037625DIPHENHYDRAMINE 50 MG/ML VIAL | $0.9399 | ML | 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.