ZINC SULFATE | N209377 | AMERICAN REGENT INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition Completeness Assessment Correspondence from FDA CDER to ... FDA-2023-P-4463 Gland Pharma Limited filed a suitability petition under 21 C.F.R. §314.93(b) on October 11, 2023, requesting permission to submit an ANDA for Zinc Sulfate Injection in two strengths (20 mg/20 mL and 50 mg/50 mL). The FDA determined the petition complete and established an April 24, 2024 review goal | Suitability | 2023-10-24 | Granted | — |
Attachment - II Copy of current RLD Zinc Sulfate Injection USP 10 mg per 10 m... FDA-2023-P-4463 Gland Pharma Limited filed a citizen petition regarding the suitability of Zinc Sulfate Injection USP 10 mg per 10 mL as a reference listed drug, submitting the current package insert of the RLD in support of their petition to establish bioequivalence standards for an ANDA submission. | Suitability | 2023-10-12 | Granted | Gland Pharma Limited |
Suitability Petition from Gland Pharma Limited FDA-2023-P-4463 Gland Pharma Limited filed this suitability petition on October 1, 2023, requesting that the FDA declare Zinc Sulfate Injection USP in two additional strengths (20 mg/20 mL and 50 mg/50 mL, both at 1 mg/mL concentration) suitable for review under a Prior Approval supplement to their already-approved | Suitability | 2023-10-12 | Granted | Gland Pharma Limited |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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