Details for New Drug Application (NDA): 078939
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The generic ingredient in ETHAMBUTOL HYDROCHLORIDE is ethambutol hydrochloride. There are five drug master file entries for this compound. Seven 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 |
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 |
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