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CORTISONE ACETATE

NDA

CORTISONE ACETATE | N008284 | PANRAY CORP SUB ORMONT DRUG AND CHEMICAL CO INC

2 strengths0 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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain1 active DMF5 inactive

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

HENAN LIHUA PHARMACEUTICAL CO LTDCORTISONE ACETATE

DMF 316412017

ROUSSEL CORPInactiveCORTISONE ACETATE

DMF 1061953

PHARMACIA AND UPJOHNInactiveCORTISONE (MICRONIZED, ACETATE AND STERILE)

DMF 14061969

ROUSSELL UCLAFInactiveCORTISONE ACETATE

DMF 37981980

DIOSYNTH BVInactiveCORTISONE ACETATE MICRO

DMF 39081980

UPJOHN COInactiveCORTISONE ACETATE USP, MICRO & NON MICRO

DMF 54871984

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

Products (2)

Sort:

#001 — 25MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#002 — 5MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982