Details for New Drug Application (NDA): 075095
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NDA 075095 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. Seven 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. Seven suppliers are listed for this compound. Additional details are available on the ethambutol hydrochloride profile page.
Summary for 075095
| Tradename: | ETHAMBUTOL HYDROCHLORIDE |
| Applicant: | Epic Pharma Llc |
| Ingredient: | ethambutol hydrochloride |
| Patents: | 0 |
Suppliers and Packaging for NDA: 075095
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ETHAMBUTOL HYDROCHLORIDE | ethambutol hydrochloride | TABLET;ORAL | 075095 | ANDA | Epic Pharma, LLC | 42806-101 | 42806-101-01 | 100 TABLET, FILM COATED in 1 BOTTLE (42806-101-01) |
| ETHAMBUTOL HYDROCHLORIDE | ethambutol hydrochloride | TABLET;ORAL | 075095 | ANDA | Epic Pharma, LLC | 42806-102 | 42806-102-01 | 100 TABLET, FILM COATED in 1 BOTTLE (42806-102-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
| Approval Date: | Nov 30, 1999 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 400MG | ||||
| Approval Date: | Nov 30, 1999 | TE: | AB | RLD: | No | ||||
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