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ZINC SULFATE

ANDA

ZINC SULFATE | A216249 | GLAND PHARMA LTD

3 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: ZINC SULFATE(TE code: AP)

Citizen Petitions

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
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	Open	Gland Pharma Limited

Source: Regulations.gov. FDA citizen petitions matched by application number.

API Supply Chain6 active DMFs

6 active API suppliers hold Drug Master Files for this ingredient.

JOST CHEMICAL COZINC SULFATE HEPTAHYDRATE

DMF 348562020

GLAND PHARMA LTDZINC SULFATE HEPTAHYDRATE

DMF 349732020

MACCO ORGANIQUES SROZINC SULFATE HEPTAHYDRATE

DMF 351292020

METROCHEM API PRIVATE LTDZINC SULFATE HEPTAHYDRATE USP

DMF 369632022

BIOPHORE INDIA PHARMACEUTICALS PVT LTDZINC SULFATE HEPTAHYDRATE

DMF 373242022

MAITHRI DRUGS PRIVATE LTDZINC SULFATE HEPTAHYDRATE USP

DMF 404462024

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Aug 25, 2022	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — EQ 25MG BASE/5ML (EQ 5MG BASE/ML)

0 patents0 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: May 3, 2022

No patent or exclusivity listings for this strength.

#002 — EQ 30MG BASE/10ML (EQ 3MG BASE/ML)

0 patents0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: May 3, 2022

#003 — EQ 10MG BASE/10ML (EQ 1MG BASE/ML)

0 patents0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: Sep 1, 2023