Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050445
Company: BAUSCH
Company: BAUSCH
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MINOCIN | MINOCYCLINE HYDROCHLORIDE | EQ 50MG BASE/5ML | SUSPENSION;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 |
|---|---|---|---|---|---|---|---|
| 10/26/1972 | ORIG-1 | Approval | UNKNOWN |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/16/2018 | SUPPL-30 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050445s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/050445Orig1030ltr.pdf | |
| 02/25/2015 | SUPPL-29 | Labeling-Patient Package Insert |
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/2015/050445s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050445Orig1s029ltr.pdf |
| 09/14/2010 | SUPPL-28 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050445s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050445s028ltr.pdf | |
| 01/16/2007 | SUPPL-27 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050444s045,050445s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050444s045, 050445s027ltr.pdf | |
| 09/28/2005 | SUPPL-26 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050444s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050444s044,050445s026,050649s018ltr.pdf | |
| 05/27/2004 | SUPPL-24 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50445slr023,024ltr.pdf |
| 05/27/2004 | SUPPL-23 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50445slr023,024ltr.pdf |
| 02/17/2005 | SUPPL-22 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/50444s038,50445s022,50649s015ltr.pdf |
| 01/28/2002 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/26/2001 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/31/2002 | SUPPL-19 | Labeling |
Letter (PDF)
Review |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50444s036ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/50-444S036_Minocin.cfm |
| 08/12/1998 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/01/2002 | SUPPL-17 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50445s11s13s17ltr.pdf |
| 08/08/1995 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 02/01/2002 | SUPPL-15 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50445s11s13s17ltr.pdf |
| 05/12/1992 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 02/01/2002 | SUPPL-13 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50445s11s13s17ltr.pdf |
| 04/10/1991 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/01/2002 | SUPPL-11 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50445s11s13s17ltr.pdf |
| 10/06/1987 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 05/01/1987 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 10/29/1986 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 01/16/1985 | SUPPL-4 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 03/01/1983 | SUPPL-1 | 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 |
|---|---|---|---|---|---|
| 11/16/2018 | SUPPL-30 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050445s030lbl.pdf | |
| 02/25/2015 | SUPPL-29 | Labeling-Patient Package Insert | 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/2015/050445s029lbl.pdf |
| 09/14/2010 | SUPPL-28 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050445s028lbl.pdf | |
| 01/16/2007 | SUPPL-27 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050444s045,050445s027lbl.pdf | |
| 09/28/2005 | SUPPL-26 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050444s044lbl.pdf |