Details for New Drug Application (NDA): 050606
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NDA 050606 describes VANCOCIN HYDROCHLORIDE, which is a drug marketed by Ani Pharms and Steriscience Speclts and is included in six NDAs. It is available from two suppliers. Additional details are available on the VANCOCIN HYDROCHLORIDE profile page.
The generic ingredient in VANCOCIN 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.
The generic ingredient in VANCOCIN 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 050606
| Tradename: | VANCOCIN HYDROCHLORIDE |
| Applicant: | Ani Pharms |
| Ingredient: | vancomycin hydrochloride |
| Patents: | 0 |
Suppliers and Packaging for NDA: 050606
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VANCOCIN HYDROCHLORIDE | vancomycin hydrochloride | CAPSULE;ORAL | 050606 | NDA | ANI Pharmaceuticals, Inc. | 62559-310 | 62559-310-20 | 2 BLISTER PACK in 1 CARTON (62559-310-20) / 10 CAPSULE in 1 BLISTER PACK |
| VANCOCIN HYDROCHLORIDE | vancomycin hydrochloride | CAPSULE;ORAL | 050606 | NDA | ANI Pharmaceuticals, Inc. | 62559-311 | 62559-311-20 | 2 BLISTER PACK in 1 CARTON (62559-311-20) / 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: | Apr 15, 1986 | TE: | AB | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 250MG BASE | ||||
| Approval Date: | Apr 15, 1986 | TE: | AB | RLD: | Yes | ||||
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