Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 065131
Company: STRIDES PHARMA
Company: STRIDES PHARMA
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 | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
04/16/2003 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
05/11/2012 | SUPPL-17 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/065131s017lbl.pdf | |
01/19/2010 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
06/30/2008 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
03/17/2005 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
01/05/2004 | SUPPL-1 | Labeling |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
05/11/2012 | SUPPL-17 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/065131s017lbl.pdf |
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 |