VANCOMYCIN HYDROCHLORIDE | A061667 | ANI PHARMACEUTICALS INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Citizen Petition from Lachman Consulting Services, Inc. FDA-2020-P-2318 Lachman Consulting Services, Inc. filed this suitability petition on behalf of a client on December 18, 2020, requesting that the FDA declare Vancomycin Hydrochloride for Oral Solution EQ 125 mg (base)/5 mL suitable for submission as an ANDA under Section 505(j)(2)(C) of the FD&C Act, referencing AN | Suitability | 2020-12-22 | Open | Lachman Consulting Services |
ATTACHMENT 2 - Current labeling for Vancomycin Hydrochloride, For Solution, O... FDA-2020-P-2187 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 | Open | Lachman Consulting Services |
Suitability Petition Supplement from King & Spalding LLP FDA-2006-P-0344 King & Spalding LLP filed supplements to two suitability petitions for Vancomycin HCl USP 750 mg formulations in both Fliptop Vial and ADD-Vantage Vial presentations. The petitioner requested FDA approval under 21 U.S.C. § 355(j)(2)(C) to establish these intermediate-strength vials as suitable for a | Suitability | 2008-11-15 | Open | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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