Treats Clostridioides difficil e-associated diarrhea. ANDA 65490, held by Strides Pharma. Vancomycin Hydrochloride.
As of Nov 15, 2026, ANDA 65490 (Vancomycin Hydrochloride), held by Strides Pharma, was first approved by FDA on Apr 9, 2012, with 4 approved supplements and 0 published complete response letters.
Vancomycin hydrochloride capsules are indicated for the treatment of Clostridioides difficil e-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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 9, 2012 | Original application | Approved |
| Vancomycin HydrochlorideEQ 125MG BASE · capsule;oral | Vancomycin Hydrochloride | Rx |
| Vancomycin HydrochlorideEQ 250MG BASE · capsule;oral | Vancomycin Hydrochloride | Rx |
| Mar 6, 2024 | Supplement 14Labeling · Standard review | Approved | None posted |
| Mar 6, 2024 | Supplement 15Labeling · Standard review | Approved | None posted |
| Mar 6, 2024 | Supplement 16Labeling · Standard review | Approved | None posted |
| May 3, 2019 | Supplement 10Manufacturing · Standard review | Approved | None posted |
| Apr 9, 2012 | Original application | Approved |
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
