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CELESTONE

NDA

BETAMETHASONE SODIUM PHOSPHATE | N017561 | SCHERING CORP SUB SCHERING PLOUGH CORP

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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain4 active DMFs5 inactive

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

HOVIONE FARMACIENCIA SABETAMETHASONE SODIUM PHOSPHATE

DMF 66871986

SYMBIOTEC PHARMALAB PRIVATE LTDBETAMETHASONE SODIUM PHOSPHATE USP

DMF 374662022

CURIA SPAIN SAUBETAMETHASONE SODIUM PHOSPHATE

DMF 388312023

HENAN LIHUA PHARMACEUTICAL CO LTDBETAMETHASONE SODIUM PHOSPHATE

DMF 392572024

DIOSYNTH BVInactiveBETAMETHASONE SODIUM PHOSPHATE IN THE OSS FACIL. ON KLOOSTERSTRAT 6

DMF 55811984

COMPANIA ESPANOLA DE SINTESIS QUIMICA SAInactiveBETAMETHASONE SODIUM PHOSPHATE

DMF 67271986

HOECHST MARION ROUSSEL SAInactiveBETAMETHASONE SODIUM PHOSPHATE

DMF 104231993

CRYSTAL PHARMA SAUInactiveBETAMETHASONE SODIUM PHOSPHATE

DMF 178032004

MAHIMA LIFE SCIENCES PRIVATE LTDInactiveBETAMETHASONE SODIUM PHOSPHATE USP

DMF 226462008

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jul 6, 2003	SUPPL -13	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 3MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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.