Details for New Drug Application (NDA): 078939
✉ Email this page to a colleague
NDA 078939 describes ETHAMBUTOL HYDROCHLORIDE, which is a drug marketed by Barr, Epic Pharma Llc, and Lupin, and is included in three NDAs. It is available from six suppliers. Additional details are available on the ETHAMBUTOL HYDROCHLORIDE profile page.
The generic ingredient in ETHAMBUTOL HYDROCHLORIDE is ethambutol hydrochloride. There are five drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the ethambutol hydrochloride profile page.
The generic ingredient in ETHAMBUTOL HYDROCHLORIDE is ethambutol hydrochloride. There are five drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the ethambutol hydrochloride profile page.
Summary for 078939
| Tradename: | ETHAMBUTOL HYDROCHLORIDE |
| Applicant: | Lupin |
| Ingredient: | ethambutol hydrochloride |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 078939
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ETHAMBUTOL HYDROCHLORIDE | ethambutol hydrochloride | TABLET;ORAL | 078939 | ANDA | A-S Medication Solutions | 50090-5140 | 50090-5140-0 | 100 TABLET in 1 BOTTLE (50090-5140-0) |
| ETHAMBUTOL HYDROCHLORIDE | ethambutol hydrochloride | TABLET;ORAL | 078939 | ANDA | RPK Pharmaceuticals, Inc. | 53002-6580 | 53002-6580-0 | 100 TABLET in 1 BOTTLE (53002-6580-0) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
| Approval Date: | Jun 17, 2009 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 400MG | ||||
| Approval Date: | Jun 17, 2009 | TE: | AB | RLD: | No | ||||
Complete Access Available with Subscription
