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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202687
Company: STRIDES PHARMA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
METHOXSALEN METHOXSALEN 10MG 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
06/05/2014 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202687Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/08/2024 SUPPL-3 Labeling-Medication Guide, Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

METHOXSALEN

CAPSULE;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
METHOXSALEN METHOXSALEN 10MG CAPSULE;ORAL Prescription No AB 202687 STRIDES PHARMA
OXSORALEN-ULTRA METHOXSALEN 10MG CAPSULE;ORAL Prescription Yes AB 019600 BAUSCH
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