Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019600
Company: BAUSCH
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OXSORALEN-ULTRA METHOXSALEN 10MG CAPSULE;ORAL Prescription AB Yes 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
10/30/1986 ORIG-1 Approval Type 3 - New Dosage Form 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
10/20/2015 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

05/29/2015 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

11/23/2001 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

03/26/2003 SUPPL-9 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19600slr006,009_oxsoralen-ultra_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19600slr006,009ltr.pdf
03/20/2001 SUPPL-8 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

05/07/1999 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

03/26/2003 SUPPL-6 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19600slr006,009_oxsoralen-ultra_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19600slr006,009ltr.pdf
04/07/1998 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

03/16/1998 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

12/08/1997 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

11/03/1998 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

10/16/1990 SUPPL-1 Manufacturing (CMC)-Packaging

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/26/2003 SUPPL-9 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19600slr006,009_oxsoralen-ultra_lbl.pdf
03/26/2003 SUPPL-6 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19600slr006,009_oxsoralen-ultra_lbl.pdf

OXSORALEN-ULTRA

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 202603 ACTAVIS INC
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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