Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Discontinued | 002 |
| Prescription | 003 |
| Discontinued | 004 |
Application Products
| 001 | TABLET;ORAL | 100MG | 1 | MYAMBUTOL | ETHAMBUTOL HYDROCHLORIDE |
| 002 | TABLET;ORAL | 200MG | 0 | MYAMBUTOL | ETHAMBUTOL HYDROCHLORIDE |
| 003 | TABLET;ORAL | 400MG | 1 | MYAMBUTOL | ETHAMBUTOL HYDROCHLORIDE |
| 004 | TABLET;ORAL | 500MG | 0 | MYAMBUTOL | ETHAMBUTOL HYDROCHLORIDE |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 1967-11-06 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 27 | AP | 1975-02-21 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 28 | AP | 1976-04-28 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 29 | AP | 1976-06-10 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 30 | AP | 1977-05-13 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 31 | AP | 1977-07-05 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 32 | AP | 1978-04-07 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 33 | AP | 1978-05-03 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 34 | AP | 1978-06-27 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 35 | AP | 1978-06-26 | PRIORITY |
| LABELING; Labeling | SUPPL | 36 | AP | 1978-12-21 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 37 | AP | 1979-04-03 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 38 | AP | 1979-04-03 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 39 | AP | 1981-01-09 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 40 | AP | 1981-07-29 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 41 | AP | 1981-08-18 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 42 | AP | 1981-08-18 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 43 | AP | 1981-11-03 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 44 | AP | 1982-02-24 | PRIORITY |
| LABELING; Labeling | SUPPL | 46 | AP | 1987-06-25 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 47 | AP | 1985-09-12 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 49 | AP | 1986-01-03 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 50 | AP | 1987-05-19 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 51 | AP | 1987-11-23 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 52 | AP | 1987-11-02 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 53 | AP | 1995-06-20 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 54 | AP | 1998-05-08 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 55 | AP | 1998-05-14 | PRIORITY |
| LABELING; Labeling | SUPPL | 56 | AP | 2001-10-10 | STANDARD |
| LABELING; Labeling | SUPPL | 57 | AP | 2003-02-06 | STANDARD |
| LABELING; Labeling | SUPPL | 58 | AP | 2003-02-06 | STANDARD |
| LABELING; Labeling | SUPPL | 60 | AP | 2004-03-24 | STANDARD |
| LABELING; Labeling | SUPPL | 63 | AP | 2008-10-30 | STANDARD Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 66 | AP | 2013-02-22 | PRIORITY |
Submissions Property Types
| SUPPL | 27 | Null | 0 |
| SUPPL | 28 | Null | 0 |
| SUPPL | 29 | Null | 0 |
| SUPPL | 30 | Null | 0 |
| SUPPL | 31 | Null | 0 |
| SUPPL | 32 | Null | 0 |
| SUPPL | 33 | Null | 0 |
| SUPPL | 34 | Null | 0 |
| SUPPL | 35 | Null | 0 |
| SUPPL | 37 | Null | 0 |
| SUPPL | 38 | Null | 0 |
| SUPPL | 39 | Null | 0 |
| SUPPL | 40 | Null | 0 |
| SUPPL | 41 | Null | 0 |
| SUPPL | 42 | Null | 0 |
| SUPPL | 43 | Null | 0 |
| SUPPL | 44 | Null | 0 |
| SUPPL | 47 | Null | 0 |
| SUPPL | 49 | Null | 0 |
| SUPPL | 50 | Null | 0 |
| SUPPL | 51 | Null | 0 |
| SUPPL | 52 | Null | 0 |
| SUPPL | 53 | Null | 0 |
| SUPPL | 54 | Null | 0 |
| SUPPL | 55 | Null | 0 |
| SUPPL | 60 | Null | 9 |
| SUPPL | 66 | Null | 0 |
TE Codes
| 001 | Prescription | AB |
| 003 | Prescription | AB |
CDER Filings
STI PHARMA LLC
cder:Array
(
[0] => Array
(
[ApplNo] => 16320
[companyName] => STI PHARMA LLC
[docInserts] => ["",""]
[products] => [{"drugName":"MYAMBUTOL","activeIngredients":"ETHAMBUTOL HYDROCHLORIDE","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"MYAMBUTOL","activeIngredients":"ETHAMBUTOL HYDROCHLORIDE","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"MYAMBUTOL","activeIngredients":"ETHAMBUTOL HYDROCHLORIDE","strength":"400MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"MYAMBUTOL","activeIngredients":"ETHAMBUTOL HYDROCHLORIDE","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"02\/22\/2013","submission":"SUPPL-66","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/016320s066lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"10\/30\/2008","submission":"SUPPL-63","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/016320s063lbl.pdf\"}]","notes":"Please see"},{"actionDate":"03\/24\/2004","submission":"SUPPL-60","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/16320slr060_myambutol_lbl.pdf\"}]","notes":""},{"actionDate":"02\/06\/2003","submission":"SUPPL-58","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/16320slr057_Myambutol_lbl.pdf\"}]","notes":""},{"actionDate":"02\/06\/2003","submission":"SUPPL-57","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/16320slr057_Myambutol_lbl.pdf\"}]","notes":""},{"actionDate":"10\/10\/2001","submission":"SUPPL-56","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/16320s56lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"MYAMBUTOL","submission":"ETHAMBUTOL HYDROCHLORIDE","actionType":"100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"MYAMBUTOL","submission":"ETHAMBUTOL HYDROCHLORIDE","actionType":"200MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"MYAMBUTOL","submission":"ETHAMBUTOL HYDROCHLORIDE","actionType":"400MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"MYAMBUTOL","submission":"ETHAMBUTOL HYDROCHLORIDE","actionType":"500MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 2013-02-22
)
)