Clindamycin Phosphate In 5% Dextrose In Plastic Container

ANDA 203048, held by Rising. Clindamycin Phosphate.

As of Nov 15, 2026, ANDA 203048 (Clindamycin Phosphate In 5% Dextrose In Plastic Container), held by Rising, was first approved by FDA on Apr 4, 2013, with 5 approved supplements and 0 published complete response letters.

First approved: Apr 4, 2013
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Apr 4, 2013	Original application	Approved	None posted

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 6 submissions, including labeling and manufacturing supplements


May 14, 2020	Supplement 1Labeling · Standard review	Approved	None posted
May 14, 2020	Supplement 2Labeling · Standard review	Approved	None posted
May 14, 2020	Supplement 3Labeling · Standard review	Approved	None posted
May 14, 2020	Supplement 4Labeling · Standard review	Approved	None posted
May 14, 2020	Supplement 8Labeling · Standard review	Approved	None posted
Apr 4, 2013	Original application	Approved	None posted

Identifiers

Application: ANDA 203048
Drugs@FDA: Overview at FDA
Company: Rising Pharmaceuticals

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