Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 065156
Company: TORRENT
Company: TORRENT
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 50MG BASE | TABLET;ORAL | Prescription | AB | No | No |
MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 75MG BASE | TABLET;ORAL | Prescription | AB | No | No |
MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 100MG BASE | TABLET;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 |
---|---|---|---|---|---|---|---|
01/06/2004 | ORIG-1 | Approval |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/065156_s000_MinocyclineTOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/06/2020 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
||
04/06/2020 | SUPPL-15 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
05/11/2012 | SUPPL-10 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/065156Orig1s010.pdf |
10/27/2008 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
06/23/2004 | SUPPL-3 | Labeling |
Label is not available on this site. |
MINOCYCLINE HYDROCHLORIDE
TABLET;ORAL; EQ 50MG 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 50MG BASE | TABLET;ORAL | Prescription | No | AB | 213662 | AUROBINDO PHARMA LTD |
MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 50MG BASE | TABLET;ORAL | Prescription | No | AB | 215466 | BEXIMCO PHARMS USA |
MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 50MG BASE | TABLET;ORAL | Prescription | No | AB | 065436 | DR REDDYS LABS LTD |
MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 50MG BASE | TABLET;ORAL | Prescription | No | AB | 065131 | STRIDES PHARMA |
MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 50MG BASE | TABLET;ORAL | Prescription | No | AB | 090217 | SUN PHARM INDUSTRIES |
MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 50MG BASE | TABLET;ORAL | Prescription | No | AB | 065156 | TORRENT |
TABLET;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 | TABLET;ORAL | Prescription | No | AB | 213662 | AUROBINDO PHARMA LTD |
MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 75MG BASE | TABLET;ORAL | Prescription | No | AB | 215466 | BEXIMCO PHARMS USA |
MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 75MG BASE | TABLET;ORAL | Prescription | No | AB | 065436 | DR REDDYS LABS LTD |
MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 75MG BASE | TABLET;ORAL | Prescription | No | AB | 065131 | STRIDES PHARMA |
MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 75MG BASE | TABLET;ORAL | Prescription | No | AB | 090217 | SUN PHARM INDUSTRIES |
MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 75MG BASE | TABLET;ORAL | Prescription | No | AB | 065156 | TORRENT |
TABLET;ORAL; EQ 100MG 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 100MG BASE | TABLET;ORAL | Prescription | No | AB | 213662 | AUROBINDO PHARMA LTD |
MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 100MG BASE | TABLET;ORAL | Prescription | No | AB | 215466 | BEXIMCO PHARMS USA |
MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 100MG BASE | TABLET;ORAL | Prescription | No | AB | 065436 | DR REDDYS LABS LTD |
MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 100MG BASE | TABLET;ORAL | Prescription | No | AB | 065131 | STRIDES PHARMA |
MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 100MG BASE | TABLET;ORAL | Prescription | No | AB | 090217 | SUN PHARM INDUSTRIES |
MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 100MG BASE | TABLET;ORAL | Prescription | No | AB | 065156 | TORRENT |