Details for New Drug Application (NDA): 213895
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NDA 213895 describes VANCOMYCIN, which is a drug marketed by Hikma, Fresenius Kabi Usa, Lupin, Orient Pharma Co Ltd, Pai Holdings, Strides Pharma, Watson Labs, Alkem Labs Ltd, Amneal, Aspiro, Avet Lifesciences, Eugia Pharma, Eurofarma, Gland, Hikma Pharms, Hospira, Hospira Inc, Knack, Meitheal, Mylan Labs Ltd, Plano Pharms, Sagent Pharms, Slate Run Pharma, Teva Pharms Usa, Xellia Pharms Aps, Samson Medcl, Steriscience, Zhejiang Novus Pharm, and Baxter Hlthcare, and is included in fifty-five NDAs. There are five patents protecting this drug. Additional details are available on the VANCOMYCIN profile page.
The generic ingredient in VANCOMYCIN is vancomycin hydrochloride. There are twenty-two drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the vancomycin hydrochloride profile page.
The generic ingredient in VANCOMYCIN is vancomycin hydrochloride. There are twenty-two drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the vancomycin hydrochloride profile page.
Summary for 213895
| Tradename: | VANCOMYCIN |
| Applicant: | Hikma |
| Ingredient: | vancomycin |
| Patents: | 5 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 213895
Generic Entry Date for 213895*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION;INTRAVENOUS, ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;INTRAVENOUS, ORAL | Strength | 5GM/100ML (50MG/ML) | ||||
| Approval Date: | Aug 26, 2021 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Nov 6, 2035 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | METHOD OF TREATING BACTERIAL INFECTIONS | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Nov 6, 2035 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | METHOD OF TREATING BACTERIAL INFECTIONS | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Nov 6, 2035 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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