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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207792
Company: AMNEAL PHARMS NY
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ISOTRETINOIN ISOTRETINOIN 10MG CAPSULE;ORAL Prescription AB1 No No
ISOTRETINOIN ISOTRETINOIN 20MG CAPSULE;ORAL Prescription AB1 No No
ISOTRETINOIN ISOTRETINOIN 30MG CAPSULE;ORAL Prescription AB1 No No
ISOTRETINOIN ISOTRETINOIN 40MG 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
09/29/2017 ORIG-1 Approval STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/06/2022 SUPPL-20 REMS - MODIFIED - D-N-A

Label is not available on this site.

08/24/2022 SUPPL-19 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

11/08/2021 SUPPL-15 Labeling-Medication Guide, Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

10/08/2021 SUPPL-14 REMS - MODIFIED - D-N-A

Label is not available on this site.

12/09/2020 SUPPL-11 REMS - MODIFIED - D-N-A

Label is not available on this site.

08/31/2018 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

04/23/2018 SUPPL-3 REMS - MODIFIED - D-N-A

Label is not available on this site.

05/02/2018 SUPPL-2 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

ISOTRETINOIN

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; 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

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
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