Details for New Drug Application (NDA): 061667
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NDA 061667 describes VANCOCIN HYDROCHLORIDE, which is a drug marketed by Ani Pharms and Steriscience and is included in six NDAs. It is available from four 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-four 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-four suppliers are listed for this compound. Additional details are available on the vancomycin hydrochloride profile page.
Summary for 061667
| Tradename: | VANCOCIN HYDROCHLORIDE |
| Applicant: | Ani Pharms |
| Ingredient: | vancomycin hydrochloride |
| Patents: | 0 |
Suppliers and Packaging for NDA: 061667
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VANCOCIN HYDROCHLORIDE | vancomycin hydrochloride | FOR SOLUTION;ORAL | 061667 | ANDA | ANI Pharmaceuticals, Inc. | 62559-830 | 62559-830-03 | 300 mL in 1 BOTTLE, PLASTIC (62559-830-03) |
| VANCOCIN HYDROCHLORIDE | vancomycin hydrochloride | FOR SOLUTION;ORAL | 061667 | ANDA | ANI Pharmaceuticals, Inc. | 62559-830 | 62559-830-55 | 150 mL in 1 BOTTLE, PLASTIC (62559-830-55) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | FOR SOLUTION;ORAL | Strength | EQ 500MG BASE/6ML | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SOLUTION;ORAL | Strength | EQ 250MG BASE/5ML | ||||
| Approval Date: | Jul 13, 1983 | TE: | RLD: | No | |||||
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