Details for New Drug Application (NDA): 050624

NDA 050624 describes ROCEPHIN W/ DEXTROSE IN PLASTIC CONTAINER, which is a drug marketed by Hoffmann La Roche and is included in one NDA. Additional details are available on the ROCEPHIN W/ DEXTROSE IN PLASTIC CONTAINER profile page.

The generic ingredient in ROCEPHIN W/ DEXTROSE IN PLASTIC CONTAINER is ceftriaxone sodium. There are twenty-six drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the ceftriaxone sodium profile page.

Summary for 050624

Tradename:	ROCEPHIN W/ DEXTROSE IN PLASTIC CONTAINER
Applicant:	Hoffmann La Roche
Ingredient:	ceftriaxone sodium
Patents:	0

Medical Subject Heading (MeSH) Categories for 050624

Anti-Bacterial Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	EQ 10MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:	Feb 11, 1987	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	EQ 20MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:	Feb 11, 1987	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	EQ 40MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:	Feb 11, 1987	TE:		RLD:	Yes

Complete Access Available with Subscription