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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204453
Company: ALKEM LABS LTD

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 45MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription AB No No
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 80MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription AB No No
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 90MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription AB No No
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 105MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription AB No No
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 135MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription AB No Yes
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 65MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription AB No No
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 115MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription AB No Yes
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 55MG BASE TABLET, EXTENDED RELEASE;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
12/19/2019 ORIG-3 Approval

Label is not available on this site.
03/16/2018 ORIG-2 Approval

Label is not available on this site.
09/28/2016 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/204453Orig1s000ltr.pdf

MINOCYCLINE HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL; EQ 45MG 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 45MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204453 ALKEM LABS LTD
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 45MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202261 AUROBINDO PHARMA LTD
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 45MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 091424 CHARTWELL RX
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 45MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 090422 SANDOZ
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 45MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204394 SUN PHARM

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 204394 SUN PHARM

TABLET, EXTENDED RELEASE;ORAL; EQ 90MG 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 90MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204453 ALKEM LABS LTD
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 90MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202261 AUROBINDO PHARMA LTD
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 90MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 091424 CHARTWELL RX
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 90MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 090422 SANDOZ

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 204394 SUN PHARM

TABLET, EXTENDED RELEASE;ORAL; EQ 135MG 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 135MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204453 ALKEM LABS LTD
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 135MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202261 AUROBINDO PHARMA LTD
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 135MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 091424 CHARTWELL RX
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 135MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 090422 SANDOZ
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 135MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204394 SUN PHARM

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 204394 SUN PHARM

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 204394 SUN PHARM

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 CHARTWELL RX
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 55MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204394 SUN PHARM
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