Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076135
Company: TEVA PHARMS USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CLARAVIS ISOTRETINOIN 40MG CAPSULE;ORAL Prescription AB No Yes
CLARAVIS ISOTRETINOIN 20MG CAPSULE;ORAL Prescription AB No No
CLARAVIS ISOTRETINOIN 30MG CAPSULE;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
04/11/2003 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
08/31/2018 SUPPL-43 Labeling-Package Insert

Label is not available on this site.

04/23/2018 SUPPL-42 REMS - MODIFIED - D-N-A

Label is not available on this site.

05/02/2018 SUPPL-41 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

06/17/2017 SUPPL-38 REMS - MODIFIED - D-N-A

Label is not available on this site.

07/08/2016 SUPPL-37 REMS-Modified

Label is not available on this site.

02/04/2016 SUPPL-36 REMS-Modified

Label is not available on this site.

09/03/2015 SUPPL-35 REMS-Proposal

Label is not available on this site.

07/20/2015 SUPPL-30 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

04/12/2012 SUPPL-29 REMS-Proposal

Label is not available on this site.

10/22/2010 SUPPL-18 REMS-Proposal

Label is not available on this site.

03/25/2010 SUPPL-17 Labeling-Package Insert

Label is not available on this site.

11/02/2007 SUPPL-15 Labeling

Label is not available on this site.

02/02/2007 SUPPL-14 Labeling

Label is not available on this site.

02/02/2007 SUPPL-11 Labeling

Label is not available on this site.

08/12/2005 SUPPL-8 Labeling

Label is not available on this site.

05/11/2006 SUPPL-5 Labeling

Label is not available on this site.

CLARAVIS

CAPSULE;ORAL; 40MG
TE Code = AB

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

CAPSULE;ORAL; 20MG
TE Code = AB

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

CAPSULE;ORAL; 30MG
TE Code = AB

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

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