Details for New Drug Application (NDA): 014602

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NDA 014602 describes CELESTONE SOLUSPAN, which is a drug marketed by Organon and is included in one NDA. It is available from two suppliers. Additional details are available on the CELESTONE SOLUSPAN profile page.

The generic ingredient in CELESTONE SOLUSPAN is betamethasone acetate; betamethasone sodium phosphate. There are sixty-six drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the betamethasone acetate; betamethasone sodium phosphate profile page.

Summary for 014602

Tradename:	CELESTONE SOLUSPAN
Applicant:	Organon
Ingredient:	betamethasone acetate; betamethasone sodium phosphate
Patents:	0

Pharmacology for NDA: 014602

Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Suppliers and Packaging for NDA: 014602

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CELESTONE SOLUSPAN	betamethasone acetate; betamethasone sodium phosphate	INJECTABLE;INJECTION	014602	NDA AUTHORIZED GENERIC	Exela Pharma Sciences, LLC	51754-5060	51754-5060-1	1 VIAL, MULTI-DOSE in 1 BOX (51754-5060-1) / 5 mL in 1 VIAL, MULTI-DOSE
CELESTONE SOLUSPAN	betamethasone acetate; betamethasone sodium phosphate	INJECTABLE;INJECTION	014602	NDA	Organon LLC	78206-118	78206-118-01	1 VIAL, MULTI-DOSE in 1 BOX (78206-118-01) / 5 mL in 1 VIAL, MULTI-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	3MG/ML;EQ 3MG BASE/ML
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AB	RLD:	Yes

Expired US Patents for NDA 014602

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon	CELESTONE SOLUSPAN	betamethasone acetate; betamethasone sodium phosphate	INJECTABLE;INJECTION	014602-001	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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