Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076485
Company: DOUGLAS PHARMS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MYORISAN ISOTRETINOIN 10MG CAPSULE;ORAL Prescription AB1 No No
MYORISAN ISOTRETINOIN 20MG CAPSULE;ORAL Prescription AB1 No No
MYORISAN ISOTRETINOIN 40MG CAPSULE;ORAL Prescription AB1 No No
MYORISAN ISOTRETINOIN 30MG CAPSULE;ORAL Prescription AB1 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
01/19/2012 ORIG-1 Approval Review (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/076485Orig1s003.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/08/2021 SUPPL-28 Labeling-Package Insert

Label is not available on this site.
10/08/2021 SUPPL-27 REMS - MODIFIED - D-N-A

Label is not available on this site.
12/09/2020 SUPPL-25 REMS - MODIFIED - D-N-A

Label is not available on this site.
08/31/2018 SUPPL-21 Labeling-Package Insert

Label is not available on this site.
04/23/2018 SUPPL-19 REMS - MODIFIED - D-N-A

Label is not available on this site.
05/02/2018 SUPPL-18 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.
06/17/2017 SUPPL-15 REMS - MODIFIED - D-N-A

Label is not available on this site.
07/08/2016 SUPPL-13 REMS-Modified

Label is not available on this site.
02/04/2016 SUPPL-12 REMS-Modified

Label is not available on this site.
09/03/2015 SUPPL-10 REMS-Modified

Label is not available on this site.
12/13/2014 SUPPL-4 Labeling-Package Insert

Label is not available on this site.
04/30/2012 SUPPL-3 REMS-Modified

Label is not available on this site.

MYORISAN

CAPSULE;ORAL; 10MG
TE Code = AB1

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMNESTEEM ISOTRETINOIN 10MG CAPSULE;ORAL Prescription No AB1 075945 MYLAN PHARMS INC
CLARAVIS ISOTRETINOIN 10MG CAPSULE;ORAL Prescription No AB1 076356 TEVA PHARMS USA
ISOTRETINOIN ISOTRETINOIN 10MG CAPSULE;ORAL Prescription No AB1 207792 AMNEAL PHARMS NY
MYORISAN ISOTRETINOIN 10MG CAPSULE;ORAL Prescription No AB1 076485 DOUGLAS PHARMS
ZENATANE ISOTRETINOIN 10MG CAPSULE;ORAL Prescription No AB1 202099 DR REDDYS LABS LTD

CAPSULE;ORAL; 20MG
TE Code = AB1

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMNESTEEM ISOTRETINOIN 20MG CAPSULE;ORAL Prescription No AB1 075945 MYLAN PHARMS INC
CLARAVIS ISOTRETINOIN 20MG CAPSULE;ORAL Prescription No AB1 076135 TEVA PHARMS USA
ISOTRETINOIN ISOTRETINOIN 20MG CAPSULE;ORAL Prescription No AB1 207792 AMNEAL PHARMS NY
MYORISAN ISOTRETINOIN 20MG CAPSULE;ORAL Prescription No AB1 076485 DOUGLAS PHARMS
ZENATANE ISOTRETINOIN 20MG CAPSULE;ORAL Prescription No AB1 202099 DR REDDYS LABS LTD

CAPSULE;ORAL; 40MG
TE Code = AB1

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMNESTEEM ISOTRETINOIN 40MG CAPSULE;ORAL Prescription No AB1 075945 MYLAN PHARMS INC
CLARAVIS ISOTRETINOIN 40MG CAPSULE;ORAL Prescription No AB1 076135 TEVA PHARMS USA
ISOTRETINOIN ISOTRETINOIN 40MG CAPSULE;ORAL Prescription No AB1 207792 AMNEAL PHARMS NY
MYORISAN ISOTRETINOIN 40MG CAPSULE;ORAL Prescription No AB1 076485 DOUGLAS PHARMS
ZENATANE ISOTRETINOIN 40MG CAPSULE;ORAL Prescription No AB1 202099 DR REDDYS LABS LTD

CAPSULE;ORAL; 30MG
TE Code = AB1

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CLARAVIS ISOTRETINOIN 30MG CAPSULE;ORAL Prescription No AB1 076135 TEVA PHARMS USA
ISOTRETINOIN ISOTRETINOIN 30MG CAPSULE;ORAL Prescription No AB1 207792 AMNEAL PHARMS NY
MYORISAN ISOTRETINOIN 30MG CAPSULE;ORAL Prescription No AB1 076485 DOUGLAS PHARMS
ZENATANE ISOTRETINOIN 30MG CAPSULE;ORAL Prescription No AB1 202099 DR REDDYS LABS LTD

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