Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 016320
Company: STI PHARMA LLC
Company: STI PHARMA LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MYAMBUTOL | ETHAMBUTOL HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | AB | Yes | No |
| MYAMBUTOL | ETHAMBUTOL HYDROCHLORIDE | 200MG | TABLET;ORAL | Discontinued | None | No | No |
| MYAMBUTOL | ETHAMBUTOL HYDROCHLORIDE | 400MG | TABLET;ORAL | Prescription | AB | Yes | Yes |
| MYAMBUTOL | ETHAMBUTOL HYDROCHLORIDE | 500MG | TABLET;ORAL | Discontinued | None | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 11/06/1967 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/22/2013 | SUPPL-66 | Manufacturing (CMC) |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/016320s066lbl.pdf | |
| 10/30/2008 | SUPPL-63 | Labeling |
Label (PDF)
Letter (PDF) |
Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/016320s063lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/016320s063ltr.pdf |
| 03/24/2004 | SUPPL-60 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/16320slr060_myambutol_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/16320slr060ltr.pdf | |
| 02/06/2003 | SUPPL-58 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/16320slr057_Myambutol_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/16320slr057,058ltr.pdf | |
| 02/06/2003 | SUPPL-57 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/16320slr057_Myambutol_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/16320slr057,058ltr.pdf | |
| 10/10/2001 | SUPPL-56 | Labeling |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/16320s56lbl.pdf | |
| 05/14/1998 | SUPPL-55 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/08/1998 | SUPPL-54 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/20/1995 | SUPPL-53 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/02/1987 | SUPPL-52 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 11/23/1987 | SUPPL-51 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/19/1987 | SUPPL-50 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 01/03/1986 | SUPPL-49 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/12/1985 | SUPPL-47 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/25/1987 | SUPPL-46 | Labeling |
Label is not available on this site. |
||
| 02/24/1982 | SUPPL-44 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/03/1981 | SUPPL-43 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/18/1981 | SUPPL-42 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 08/18/1981 | SUPPL-41 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/29/1981 | SUPPL-40 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/09/1981 | SUPPL-39 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/03/1979 | SUPPL-38 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/03/1979 | SUPPL-37 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/21/1978 | SUPPL-36 | Labeling |
Label is not available on this site. |
||
| 06/26/1978 | SUPPL-35 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/27/1978 | SUPPL-34 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/03/1978 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/07/1978 | SUPPL-32 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/05/1977 | SUPPL-31 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 05/13/1977 | SUPPL-30 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/10/1976 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/28/1976 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/21/1975 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 02/22/2013 | SUPPL-66 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/016320s066lbl.pdf |
| 10/30/2008 | SUPPL-63 | Labeling | Label (PDF) | Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/016320s063lbl.pdf |
| 03/24/2004 | SUPPL-60 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/16320slr060_myambutol_lbl.pdf | |
| 02/06/2003 | SUPPL-58 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/16320slr057_Myambutol_lbl.pdf | |
| 02/06/2003 | SUPPL-57 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/16320slr057_Myambutol_lbl.pdf | |
| 10/10/2001 | SUPPL-56 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/16320s56lbl.pdf |
MYAMBUTOL
TABLET;ORAL; 100MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ETHAMBUTOL HYDROCHLORIDE | ETHAMBUTOL HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 075095 | EPIC PHARMA LLC |
| ETHAMBUTOL HYDROCHLORIDE | ETHAMBUTOL HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 078939 | LUPIN |
| MYAMBUTOL | ETHAMBUTOL HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | Yes | AB | 016320 | STI PHARMA LLC |
TABLET;ORAL; 400MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ETHAMBUTOL HYDROCHLORIDE | ETHAMBUTOL HYDROCHLORIDE | 400MG | TABLET;ORAL | Prescription | No | AB | 075095 | EPIC PHARMA LLC |
| ETHAMBUTOL HYDROCHLORIDE | ETHAMBUTOL HYDROCHLORIDE | 400MG | TABLET;ORAL | Prescription | No | AB | 078939 | LUPIN |
| MYAMBUTOL | ETHAMBUTOL HYDROCHLORIDE | 400MG | TABLET;ORAL | Prescription | Yes | AB | 016320 | STI PHARMA LLC |