Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 202099
Company: DR REDDYS LABS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZENATANE ISOTRETINOIN 10MG CAPSULE;ORAL Prescription AB No No
ZENATANE ISOTRETINOIN 20MG CAPSULE;ORAL Prescription AB No No
ZENATANE ISOTRETINOIN 40MG CAPSULE;ORAL Prescription AB No No
ZENATANE 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
03/25/2013 ORIG-1 Approval Not Applicable

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-15 Labeling-Package Insert

Label is not available on this site.

04/23/2018 SUPPL-12 REMS - MODIFIED - D-N-A

Label is not available on this site.

05/02/2018 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

06/17/2017 SUPPL-9 REMS - MODIFIED - D-N-A

Label is not available on this site.

07/08/2016 SUPPL-7 REMS-Modified

Label is not available on this site.

02/04/2016 SUPPL-5 REMS-Modified

Label is not available on this site.

09/03/2015 SUPPL-4 REMS-Modified

Label is not available on this site.

02/23/2015 SUPPL-2 Labeling-Container/Carton Labels, Labeling-Package Insert, REMS-Modified

Label is not available on this site.

ZENATANE

CAPSULE;ORAL; 10MG
TE Code = AB

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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English