← FDA DRUG APPROVALS

FDA NDA · NDA016320

ETHAMBUTOL HYDROCHLORIDE

Sponsor: KANCHAN HLTHCARE

APPLICATION
NDA016320
TYPE
NDA
ORIGINAL APPROVAL
1967-11-06
LATEST ACTION
2013-02-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued, Prescription

Products

MYAMBUTOLDiscontinued
ETHAMBUTOL HYDROCHLORIDE 200MG · TABLET · ORAL
MYAMBUTOL · ReferencePrescription
ETHAMBUTOL HYDROCHLORIDE 400MG · TABLET · ORAL
MYAMBUTOL · ReferencePrescription
ETHAMBUTOL HYDROCHLORIDE 100MG · TABLET · ORAL
MYAMBUTOLDiscontinued
ETHAMBUTOL HYDROCHLORIDE 500MG · TABLET · ORAL

Approval history

2013-02-22Manufacturing (CMC) · Supplement 66 · priority — Label ↗AP
2008-10-30Labeling · Supplement 63 · standard — Letter ↗AP
2004-03-24Labeling · Supplement 60 · standard — Letter ↗AP
2003-02-06Labeling · Supplement 58 · standard — Letter ↗AP
2003-02-06Labeling · Supplement 57 · standard — Label ↗AP
2001-10-10Labeling · Supplement 56 · standard — Label ↗AP
1998-05-14Manufacturing (CMC) · Supplement 55 · priorityAP
1998-05-08Manufacturing (CMC) · Supplement 54 · priorityAP
1995-06-20Manufacturing (CMC) · Supplement 53 · priorityAP
1987-11-23Manufacturing (CMC) · Supplement 51 · priorityAP
1987-11-02Manufacturing (CMC) · Supplement 52 · priorityAP
1987-06-25Labeling · Supplement 46AP
1987-05-19Manufacturing (CMC) · Supplement 50 · priorityAP
1986-01-03Manufacturing (CMC) · Supplement 49 · priorityAP
1985-09-12Manufacturing (CMC) · Supplement 47 · priorityAP
1982-02-24Manufacturing (CMC) · Supplement 44 · priorityAP
1981-11-03Manufacturing (CMC) · Supplement 43 · priorityAP
1981-08-18Manufacturing (CMC) · Supplement 41 · priorityAP
1981-08-18Manufacturing (CMC) · Supplement 42 · priorityAP
1981-07-29Manufacturing (CMC) · Supplement 40 · priorityAP
1981-01-09Manufacturing (CMC) · Supplement 39 · priorityAP
1979-04-03Manufacturing (CMC) · Supplement 38 · priorityAP
1979-04-03Manufacturing (CMC) · Supplement 37 · priorityAP
1978-12-21Labeling · Supplement 36AP
1978-06-27Manufacturing (CMC) · Supplement 34 · priorityAP
1978-06-26Manufacturing (CMC) · Supplement 35 · priorityAP
1978-05-03Manufacturing (CMC) · Supplement 33 · priorityAP
1978-04-07Manufacturing (CMC) · Supplement 32 · priorityAP
1977-07-05Manufacturing (CMC) · Supplement 31 · priorityAP
1977-05-13Manufacturing (CMC) · Supplement 30 · priorityAP
1976-06-10Manufacturing (CMC) · Supplement 29 · priorityAP
1976-04-28Manufacturing (CMC) · Supplement 28 · priorityAP
1975-02-21Manufacturing (CMC) · Supplement 27 · priorityAP
1967-11-06Type 1 - New Molecular Entity · Original · priorityAP
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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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