Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 063065
Company: WATSON LABS
Company: WATSON LABS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 100MG BASE | CAPSULE;ORAL | Prescription | AB | No | No |
| MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE;ORAL | Prescription | AB | 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 |
|---|---|---|---|---|---|---|---|
| 12/30/1991 | ORIG-1 | Approval |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/63065_Minocycline Hydrochloride.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/05/2020 | SUPPL-59 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
| 05/05/2020 | SUPPL-58 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 05/05/2020 | SUPPL-56 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/20/2008 | SUPPL-44 | Labeling |
Label is not available on this site. |
||
| 04/25/2008 | SUPPL-40 | Labeling |
Label is not available on this site. |
||
| 10/22/2001 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 10/22/2001 | SUPPL-19 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/25/2001 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/02/1999 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/10/1999 | SUPPL-15 | Labeling |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/63065S015_Minocycline%20Hydrochloride_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/63065s14s15apl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/063065s14s15_Minocycline_toc.cfm | |
| 06/10/1999 | SUPPL-14 | Manufacturing (CMC)-New Strength |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/63065S015_Minocycline%20Hydrochloride_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/63065s14s15apl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/063065s14s15_Minocycline_toc.cfm | |
| 12/09/1998 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/07/1998 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/07/1998 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/07/1998 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/12/1998 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/12/1998 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/05/1997 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/08/1996 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 03/04/1996 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 07/22/1992 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 06/10/1999 | SUPPL-15 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/63065S015_Minocycline%20Hydrochloride_Prntlbl.pdf | |
| 06/10/1999 | SUPPL-14 | Manufacturing (CMC)-New Strength | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/63065S015_Minocycline%20Hydrochloride_Prntlbl.pdf |
MINOCYCLINE HYDROCHLORIDE
CAPSULE;ORAL; EQ 100MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| MINOCIN | MINOCYCLINE HYDROCHLORIDE | EQ 100MG BASE | CAPSULE;ORAL | Prescription | Yes | AB | 050649 | BAUSCH |
| MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 100MG BASE | CAPSULE;ORAL | Prescription | No | AB | 065470 | AUROBINDO PHARMA |
| MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 100MG BASE | CAPSULE;ORAL | Prescription | No | AB | 065005 | IMPAX LABS |
| MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 100MG BASE | CAPSULE;ORAL | Prescription | No | AB | 090867 | SUN PHARM INDS INC |
| MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 100MG BASE | CAPSULE;ORAL | Prescription | No | AB | 065062 | TORRENT |
| MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 100MG BASE | CAPSULE;ORAL | Prescription | No | AB | 063065 | WATSON LABS |
| MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 100MG BASE | CAPSULE;ORAL | Prescription | No | AB | 063009 | ZYDUS |
CAPSULE;ORAL; EQ 75MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE;ORAL | Prescription | No | AB | 065470 | AUROBINDO PHARMA |
| MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE;ORAL | Prescription | No | AB | 065005 | IMPAX LABS |
| MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE;ORAL | Prescription | No | AB | 090867 | SUN PHARM INDS INC |
| MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE;ORAL | Prescription | No | AB | 065062 | TORRENT |
| MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE;ORAL | Prescription | No | AB | 063065 | WATSON LABS |
| MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE;ORAL | Prescription | No | AB | 063009 | ZYDUS |