Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 212333
Company: UPSHER SMITH LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ISOTRETINOIN ISOTRETINOIN 10MG CAPSULE;ORAL Prescription AB2 No No
ISOTRETINOIN ISOTRETINOIN 20MG CAPSULE;ORAL Prescription AB2 No No
ISOTRETINOIN ISOTRETINOIN 30MG CAPSULE;ORAL Prescription AB2 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
09/21/2021 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/212333Orig1s000TAltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/08/2021 SUPPL-1 REMS - MODIFIED - D-N-A

Label is not available on this site.

ISOTRETINOIN

CAPSULE;ORAL; 10MG
TE Code = AB2

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ABSORICA ISOTRETINOIN 10MG CAPSULE;ORAL Prescription Yes AB2 021951 SUN PHARM INDS INC
ISOTRETINOIN ISOTRETINOIN 10MG CAPSULE;ORAL Prescription No AB2 205063 ACTAVIS LABS FL
ISOTRETINOIN ISOTRETINOIN 10MG CAPSULE;ORAL Prescription No AB2 212333 UPSHER SMITH LABS

CAPSULE;ORAL; 20MG
TE Code = AB2

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ABSORICA ISOTRETINOIN 20MG CAPSULE;ORAL Prescription Yes AB2 021951 SUN PHARM INDS INC
ISOTRETINOIN ISOTRETINOIN 20MG CAPSULE;ORAL Prescription No AB2 205063 ACTAVIS LABS FL
ISOTRETINOIN ISOTRETINOIN 20MG CAPSULE;ORAL Prescription No AB2 212333 UPSHER SMITH LABS

CAPSULE;ORAL; 30MG
TE Code = AB2

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ABSORICA ISOTRETINOIN 30MG CAPSULE;ORAL Prescription Yes AB2 021951 SUN PHARM INDS INC
ISOTRETINOIN ISOTRETINOIN 30MG CAPSULE;ORAL Prescription No AB2 205063 ACTAVIS LABS FL
ISOTRETINOIN ISOTRETINOIN 30MG CAPSULE;ORAL Prescription No AB2 212333 UPSHER SMITH LABS

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