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HYDROCORTONE

NDA

HYDROCORTISONE SODIUM PHOSPHATE | N012052 | MERCK AND CO INC

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

3 petitions from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Interim Response Letter from FDA CDER to Hyman, Phelps & McNamara, P.C. FDA-2021-P-0940 Hyman, Phelps & McNamara, P.C. filed a citizen petition requesting that the FDA determine whether Hydrocortone (hydrocortisone sodium phosphate) injection, 50 mg base/mL approved under NDA 012052 was voluntarily withdrawn due to safety or efficacy reasons. The FDA issued an interim response stating	Other	2022-02-22	Granted	—
Citizen Petition from Hyman, Phelps, & McNamara, P.C. FDA-2021-P-0940 Hyman, Phelps & McNamara, P.C. filed this petition requesting that the FDA determine whether HYDROCORTONE (Hydrocortisone sodium phosphate) Injection EQ 50mg base/mL, approved under NDA 012052 and held by Merck and Co Inc, was withdrawn from the market for safety or effectiveness reasons. The petiti	505(q)	2021-08-26	Granted	Hyman, Phelps, & McNamara, P.C.
Citizen Petition from HYMAN, PHELPS & MCNAMARA, P.C. FDA-2020-P-1991 Hyman, Phelps & McNamara, P.C. filed this citizen petition pursuant to sections 505(j) and 505(w) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA determine whether Hydrocortone (hydrocortisone sodium phosphate) Injection, 50 mg base/mL, approved under NDA 012052 and held by Merck	505(q)	2020-09-21	Granted	HYMAN, PHELPS & MCNAMARA, P.C.

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

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain1 active DMF2 inactive

1 active API supplier hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

CURIA SPAIN SAUHYDROCORTISONE SODIUM PHOSPHATE

DMF 359572021

DIOSYNTH BVInactiveHYDROCORTISONE SODIUM PHOSPHATE

DMF 40261981

ROUSSELL UCLAFInactiveHYDROCORTISONE SODIUM PHOSPHATE

DMF 74161988

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

Products (1)

#001 — EQ 50MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.