Details for New Drug Application (NDA): 214913
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The generic ingredient in VANCOMYCIN HYDROCHLORIDE is vancomycin hydrochloride. There are twenty-two drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the vancomycin hydrochloride profile page.
Summary for 214913
Tradename: | VANCOMYCIN HYDROCHLORIDE |
Applicant: | Alkem Labs Ltd |
Ingredient: | vancomycin hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Medical Subject Heading (MeSH) Categories for 214913
Suppliers and Packaging for NDA: 214913
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
VANCOMYCIN HYDROCHLORIDE | vancomycin hydrochloride | FOR SOLUTION;ORAL | 214913 | ANDA | Ascend Laboratories, LLC | 67877-750 | 67877-750-58 | 1 KIT in 1 CARTON (67877-750-58) * 7.5 g in 1 BOTTLE * 295 mL in 1 BOTTLE * 147 mL in 1 BOTTLE * 3.75 g in 1 BOTTLE |
VANCOMYCIN HYDROCHLORIDE | vancomycin hydrochloride | FOR SOLUTION;ORAL | 214913 | ANDA | Ascend Laboratories, LLC | 67877-750 | 67877-750-81 | 1 KIT in 1 CARTON (67877-750-81) * 7.5 g in 1 BOTTLE * 295 mL in 1 BOTTLE * 147 mL in 1 BOTTLE * 3.75 g in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SOLUTION;ORAL | Strength | EQ 25MG BASE/ML | ||||
Approval Date: | Nov 14, 2022 | TE: | AB | RLD: | No | ||||
Regulatory Exclusivity Expiration: | Feb 25, 2024 | ||||||||
Regulatory Exclusivity Use: | PATENT CHALLENGE |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SOLUTION;ORAL | Strength | EQ 50MG BASE/ML | ||||
Approval Date: | Nov 14, 2022 | TE: | AB | RLD: | No | ||||
Regulatory Exclusivity Expiration: | Feb 25, 2024 | ||||||||
Regulatory Exclusivity Use: | PATENT CHALLENGE |
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