Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 016320
Company: KANCHAN HLTHCARE
Company: KANCHAN HLTHCARE
| 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 |
| 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 |