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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 201687
Company: PH HEALTH

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TRETINOIN TRETINOIN 10MG CAPSULE;ORAL Prescription AB No Yes

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
10/24/2012 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
07/23/2025 SUPPL-12 Labeling-Package Insert

Label is not available on this site.
10/11/2024 SUPPL-10 Labeling-Package Insert

Label is not available on this site.
10/11/2024 SUPPL-4 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

TRETINOIN

CAPSULE;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
TRETINOIN TRETINOIN 10MG CAPSULE;ORAL Prescription No AB 208279 GLENMARK PHARMS LTD
TRETINOIN TRETINOIN 10MG CAPSULE;ORAL Prescription No AB 201687 PH HEALTH
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