Clindamycin Phosphate In 5% Dextrose In Plastic Container

Treats serious infections caused by susceptible anaerobic bacteria. ANDA 201692, held by Sandoz Inc. Clindamycin Phosphate.

As of Nov 15, 2026, ANDA 201692 (Clindamycin Phosphate In 5% Dextrose In Plastic Container), held by Sandoz Inc, was first approved by FDA on May 31, 2012, with 9 approved supplements and 0 published complete response letters.

First approved: May 31, 2012
Supplements approved: 9
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Clindamycin in 5% Dextrose Injection is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin in 5% Dextrose Injection is also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below

Date	Submission	Status	Documents
May 31, 2012	Original application	Approved	Review

Products

3 strengths and forms


Clindamycin Phosphate In 5% Dextrose In Plastic ContainerEQ 6MG BASE/ML · injectable;injection	Clindamycin Phosphate	Rx
Clindamycin Phosphate In 5% Dextrose In Plastic ContainerEQ 12MG BASE/ML · injectable;injection	Clindamycin Phosphate	Rx
Clindamycin Phosphate In 5% Dextrose In Plastic ContainerEQ 18MG BASE/ML · injectable;injection	Clindamycin Phosphate	Rx

All 10 submissions, including labeling and manufacturing supplements


Oct 18, 2022	Supplement 25Labeling · Standard review	Approved	None posted
Oct 18, 2022	Supplement 24Labeling · Standard review	Approved	None posted
Oct 18, 2022	Supplement 20Labeling · Standard review	Approved	None posted
May 18, 2020	Supplement 5Labeling · Standard review	Approved	None posted
May 18, 2020	Supplement 7Labeling · Standard review	Approved	None posted
May 18, 2020	Supplement 8Labeling · Standard review	Approved	None posted
May 18, 2020	Supplement 12Labeling · Standard review	Approved	None posted
May 18, 2020	Supplement 16Labeling · Standard review	Approved	None posted
May 18, 2020	Supplement 18Labeling · Standard review	Approved	None posted
May 31, 2012	Original application	Approved	Review

Identifiers

Application: ANDA 201692
Drugs@FDA: Overview at FDA
Company: Sandoz

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters