Viewing data from:

ZINC SULFATE

ANDA

ZINC SULFATE | A214597 | NIVAGEN PHARMACEUTICALS INC

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
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	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.

Products (3)

Sort:

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

0 patents0 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: Jul 5, 2024

No patent or exclusivity listings for this strength.

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

0 patents0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: Jul 5, 2024

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

0 patents0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: Jul 5, 2024