Details for New Drug Application (NDA): 090439
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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 suppliers are listed for this compound. Additional details are available on the vancomycin hydrochloride profile page.
Summary for 090439
Tradename: | VANCOMYCIN HYDROCHLORIDE |
Applicant: | Lupin Ltd |
Ingredient: | vancomycin hydrochloride |
Patents: | 0 |
Suppliers and Packaging for NDA: 090439
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
VANCOMYCIN HYDROCHLORIDE | vancomycin hydrochloride | CAPSULE;ORAL | 090439 | ANDA | Lupin Pharmaceuticals, Inc. | 68180-166 | 68180-166-13 | 2 BLISTER PACK in 1 CARTON (68180-166-13) / 10 CAPSULE in 1 BLISTER PACK |
VANCOMYCIN HYDROCHLORIDE | vancomycin hydrochloride | CAPSULE;ORAL | 090439 | ANDA | Lupin Pharmaceuticals, Inc. | 68180-167 | 68180-167-13 | 2 BLISTER PACK in 1 CARTON (68180-167-13) / 10 CAPSULE in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 125MG BASE | ||||
Approval Date: | Jan 28, 2015 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 250MG BASE | ||||
Approval Date: | Jan 28, 2015 | TE: | AB | RLD: | No |
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