Vancocin Hydrochloride

Treats Clostridioides difficile -associated diarrhea. NDA 50606, held by Ani Pharms. Vancomycin Hydrochloride.

As of Nov 13, 2026, NDA 50606 (Vancocin Hydrochloride), held by Ani Pharms, was first approved by FDA on Mar 17, 2004, with 21 approved supplements and 0 published complete response letters.

First approved: Mar 17, 2004
Review: Standard
Supplements approved: 21
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Vancomycin Hydrochloride Capsules are indicated for the treatment of Clostridioides difficile -associated diarrhea. Vancomycin Hydrochloride Capsules are also used for the treatment of enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) in adult and pediatric patients less than 18 years of age. Limitations of Use Parenteral administration of vancomycin is not effective for the above infections; therefore, Vancomycin Hydrochloride Capsules must be given orally for these infections. Orally administered Vancomycin Hydrochloride Capsules are not effective for other types of infections.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 23 submissions below

Date	Submission	Status	Documents
Dec 14, 2011	Supplement 28Efficacy (new indication or use) · Standard review	Approved	Letter Label
Mar 17, 2004	Original application	Approved	None posted
Apr 15, 1986	Original applicationNew dosage form · Standard review	Approved	None posted

Products

2 strengths and forms

Product	Active ingredient	Marketing
Vancocin HydrochlorideEQ 125MG BASE · capsule;oral	Vancomycin Hydrochloride	RxReference drug
Vancocin HydrochlorideEQ 250MG BASE · capsule;oral	Vancomycin Hydrochloride	RxReference drug

All 23 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Dec 22, 2021	Supplement 39Labeling · Standard review	Approved	Letter Label
Jan 29, 2021	Supplement 38Labeling · Standard review	Approved	Label Letter
Aug 11, 2020	Supplement 36Labeling · Standard review	Approved	Label Letter
Dec 14, 2011	Supplement 28Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jan 8, 2010	Supplement 26Labeling · Standard review	Approved	Letter
May 27, 2004	Supplement 20Labeling · Standard review	Approved	Letter Label
Mar 17, 2004	Supplement 19Labeling · Standard review	Approved	Letter
Mar 17, 2004	Original application	Approved	None posted
May 28, 2002	Supplement 16Manufacturing · Standard review	Approved	None posted
May 24, 2002	Supplement 15Labeling · Standard review	Approved	Letter
Feb 6, 2001	Supplement 14Labeling · Standard review	Approved	None posted
Mar 18, 1998	Supplement 13Manufacturing · Standard review	Approved	None posted
May 12, 1997	Supplement 12Labeling · Standard review	Approved	None posted
Jun 14, 1996	Supplement 9Labeling	Approved	None posted
Jun 14, 1996	Supplement 6Labeling	Approved	None posted
Sep 27, 1995	Supplement 8Labeling	Approved	None posted
Jun 30, 1993	Supplement 10Labeling · Standard review	Approved	None posted
May 23, 1988	Supplement 5Labeling	Approved	None posted
Aug 18, 1987	Supplement 4Manufacturing · Standard review	Approved	None posted
Aug 12, 1987	Supplement 3Labeling	Approved	None posted
Oct 8, 1986	Supplement 2Manufacturing · Standard review	Approved	None posted
Jun 5, 1986	Supplement 1Labeling	Approved	None posted
Apr 15, 1986	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 50606
Drugs@FDA: Overview at FDA
Company: ANI 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