VANCOMYCIN HYDROCHLORIDE | A061667 | ANI PHARMACEUTICALS INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
ATTACHMENT 2 - Current labeling for Vancomycin Hydrochloride, For Solution, O... FDA-2020-P-2187 · 6 docket documents Lachman Consulting Services, Inc. filed a suitability petition regarding vancomycin hydrochloride oral solution 250 mg per 5 mL manufactured by ANI Pharmaceuticals Inc. under ANDA A061667. The petition concerns the current FDA-approved labeling for this product. | Suitability | 2020-11-16 | Withdrawn | Lachman Consulting Services, Inc. |
Citizen Petition from Hyman, Phelps & McNamara, P.C. FDA-2020-P-1626 · 4 docket documents The law firm Hyman, Phelps & McNamara, P.C. filed a citizen petition requesting that the FDA designate Vancomycin HCl for Oral Solution in two strengths—250 mg (base)/5 mL and 500 mg (base)/6 mL—approved under ANDA 061667 as Reference Listed Drugs in the Orange Book to establish a pathway for ANDA s | Other | 2020-07-02 | Withdrawn | Hyman, Phelps & McNamara, P.C. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$2.91
per ml
Lowest NADAC/Unit
$0.7193
per ml
Brand NDCs
0
Generic NDCs
3
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 62559083080VANCOMYCIN 250 MG/5 ML ORAL SOL | $2.91 | ML | Generic | — | 2025-12-17 |
| 62559083003VANCOMYCIN 250 MG/5 ML ORAL SOL | $0.8007 | ML | Generic | — | 2025-12-17 |
| 62559083055VANCOMYCIN 250 MG/5 ML ORAL SOL | $0.7193 | 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.