| 10135-796-01 |
10135-796 |
HUMAN PRESCRIPTION DRUG |
ETHAMBUTOL HYDROCHLORIDE |
ETHAMBUTOL HYDROCHLORIDE |
TABLET, FILM COATED |
ORAL |
20250826 |
N/A |
NDA |
NDA016320 |
Marlex Pharmaceuticals, Inc. |
ETHAMBUTOL HYDROCHLORIDE |
100 mg/1 |
100 TABLET, FILM COATED in 1 BOTTLE (10135-796-01) |
| 85742-006-04 |
85742-006 |
HUMAN PRESCRIPTION DRUG |
ETHAMBUTOL HYDROCHLORIDE |
ETHAMBUTOL HYDROCHLORIDE |
TABLET, FILM COATED |
ORAL |
20250826 |
N/A |
NDA |
NDA016320 |
Kanchan Healthcare Inc. |
ETHAMBUTOL HYDROCHLORIDE |
400 mg/1 |
100 TABLET, FILM COATED in 1 BOTTLE (85742-006-04) |
| 85742-005-04 |
85742-005 |
HUMAN PRESCRIPTION DRUG |
ETHAMBUTOL HYDROCHLORIDE |
ETHAMBUTOL HYDROCHLORIDE |
TABLET, FILM COATED |
ORAL |
20250826 |
N/A |
NDA |
NDA016320 |
Kanchan Healthcare Inc. |
ETHAMBUTOL HYDROCHLORIDE |
100 mg/1 |
100 TABLET, FILM COATED in 1 BOTTLE (85742-005-04) |
| 54879-002-01 |
54879-002 |
HUMAN PRESCRIPTION DRUG |
Ethambutol Hydrochloride |
Ethambutol Hydrochloride |
TABLET, FILM COATED |
ORAL |
20061215 |
N/A |
NDA AUTHORIZED GENERIC |
NDA016320 |
STI Pharma LLC |
ETHAMBUTOL HYDROCHLORIDE |
400 mg/1 |
12 CARTON in 1 BOX (54879-002-01) / 12 BOTTLE in 1 CARTON / 100 TABLET, FILM COATED in 1 BOTTLE |
| 10135-797-01 |
10135-797 |
HUMAN PRESCRIPTION DRUG |
ETHAMBUTOL HYDROCHLORIDE |
ETHAMBUTOL HYDROCHLORIDE |
TABLET, FILM COATED |
ORAL |
20250826 |
N/A |
NDA |
NDA016320 |
Marlex Pharmaceuticals, Inc. |
ETHAMBUTOL HYDROCHLORIDE |
400 mg/1 |
100 TABLET, FILM COATED in 1 BOTTLE (10135-797-01) |
| 54879-001-01 |
54879-001 |
HUMAN PRESCRIPTION DRUG |
Ethambutol Hydrochloride |
Ethambutol Hydrochloride |
TABLET, FILM COATED |
ORAL |
20061215 |
N/A |
NDA AUTHORIZED GENERIC |
NDA016320 |
STI Pharma LLC |
ETHAMBUTOL HYDROCHLORIDE |
100 mg/1 |
12 CARTON in 1 BOX (54879-001-01) / 12 BOTTLE in 1 CARTON / 100 TABLET, FILM COATED in 1 BOTTLE |