CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER — FDA application NDA050639

Application NDA050639 · type NDA · FDA status: approved · original approval 1989-08-30

Listed sponsor: PFIZER · PFE company profile · exact_unique

Sponsor as listed in Drugs@FDA at retrieval (2026-08-07); FDA sponsor listings can lag ownership transfers.

FDA application facts

Product	FDA-listed trade name	Active ingredient	Dosage form	Route	Strength	Marketing status	TE code	RLD
001	CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER	CLINDAMYCIN PHOSPHATE	INJECTABLE	INJECTION	EQ 6MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Discontinued	not listed	Yes
002	CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER	CLINDAMYCIN PHOSPHATE	INJECTABLE	INJECTION	EQ 12MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Discontinued	not listed	Yes
003	CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER	CLINDAMYCIN PHOSPHATE	INJECTABLE	INJECTION	EQ 18MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Discontinued	not listed	Yes

Product, form, strength, reference-drug and marketing-status fields: Drugs@FDA data files; TE and RLD fields: Orange Book data files. Retrieved 2026-08-07.

No Orange Book patent or exclusivity listings joined to this application.

Ingredient–compound links use FDA openFDA/GSRS identifiers and an exact lmmol InChIKey join. Ingredient names cannot create a link.

Sources: Drugs@FDA · Orange Book · openFDA application record. FDA data retrieved 2026-08-07.

Regulatory listing data as published by FDA; not medical or investment advice.