Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050808
Company: MEDICIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SOLODYN MINOCYCLINE HYDROCHLORIDE EQ 45MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET, EXTENDED RELEASE;ORAL Discontinued None Yes No
SOLODYN MINOCYCLINE HYDROCHLORIDE EQ 90MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET, EXTENDED RELEASE;ORAL Discontinued None Yes No
SOLODYN MINOCYCLINE HYDROCHLORIDE EQ 135MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET, EXTENDED RELEASE;ORAL Discontinued None Yes No
SOLODYN MINOCYCLINE HYDROCHLORIDE EQ 65MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription AB Yes No
SOLODYN MINOCYCLINE HYDROCHLORIDE EQ 115MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription AB Yes Yes
SOLODYN MINOCYCLINE HYDROCHLORIDE EQ 105MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription AB Yes No
SOLODYN MINOCYCLINE HYDROCHLORIDE EQ 80MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription AB Yes No
SOLODYN MINOCYCLINE HYDROCHLORIDE EQ 55MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription AB Yes 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
05/08/2006 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050808lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050808s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/050808s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/21/2013 SUPPL-23 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050808s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050808Orig1s023ltr.pdf
07/15/2014 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

04/17/2013 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

02/03/2016 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

04/20/2011 SUPPL-15 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050808s015ltr.pdf
03/18/2011 SUPPL-14 Labeling Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050808s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050808s014ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/050808Orig1s014.pdf
08/07/2010 SUPPL-13 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050808s013lbl.pdf
12/30/2009 SUPPL-11 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050808s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050808s011ltr.pdf
07/23/2009 SUPPL-7 Labeling-Container/Carton Labels, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050808s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050808s007ltr.pdf
02/27/2007 SUPPL-3 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/21/2013 SUPPL-23 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050808s023lbl.pdf
03/18/2011 SUPPL-14 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050808s014lbl.pdf
08/07/2010 SUPPL-13 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050808s013lbl.pdf
12/30/2009 SUPPL-11 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050808s011lbl.pdf
07/23/2009 SUPPL-7 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050808s007lbl.pdf
07/23/2009 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050808s007lbl.pdf
05/08/2006 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050808lbl.pdf

SOLODYN

TABLET, EXTENDED RELEASE;ORAL; EQ 65MG 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 65MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204453 ALKEM LABS LTD
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 65MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202261 AUROBINDO PHARMA LTD
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 65MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 091118 SUN PHARM INDS LTD
SOLODYN MINOCYCLINE HYDROCHLORIDE EQ 65MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 050808 MEDICIS

TABLET, EXTENDED RELEASE;ORAL; EQ 115MG 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 115MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204453 ALKEM LABS LTD
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 115MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202261 AUROBINDO PHARMA LTD
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 115MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 091118 SUN PHARM INDS LTD
SOLODYN MINOCYCLINE HYDROCHLORIDE EQ 115MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 050808 MEDICIS

TABLET, EXTENDED RELEASE;ORAL; EQ 105MG 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 105MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204453 ALKEM LABS LTD
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 105MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202261 AUROBINDO PHARMA LTD
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 105MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 203443 MYLAN
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 105MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204394 SIDMAK LABS INDIA
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 105MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 091118 SUN PHARM INDS LTD
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 105MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 203553 ZYDUS PHARMS
SOLODYN MINOCYCLINE HYDROCHLORIDE EQ 105MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 050808 MEDICIS

TABLET, EXTENDED RELEASE;ORAL; EQ 80MG 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 80MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204453 ALKEM LABS LTD
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 80MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202261 AUROBINDO PHARMA LTD
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 80MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 203443 MYLAN
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 80MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204394 SIDMAK LABS INDIA
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 80MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 091118 SUN PHARM INDS LTD
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 80MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 203553 ZYDUS PHARMS
SOLODYN MINOCYCLINE HYDROCHLORIDE EQ 80MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 050808 MEDICIS

TABLET, EXTENDED RELEASE;ORAL; EQ 55MG 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 55MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204453 ALKEM LABS LTD
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 55MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202261 AUROBINDO PHARMA LTD
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 55MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 091424 LUPIN LTD
SOLODYN MINOCYCLINE HYDROCHLORIDE EQ 55MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 050808 MEDICIS

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