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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019600
Company: BAUSCH

Products on NDA 019600

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OXSORALEN-ULTRA	METHOXSALEN	10MG	CAPSULE;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019600

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.

Labels for NDA 019600

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

Therapeutic Equivalents for NDA 019600

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	202687	ONESOURCE SPECIALTY
OXSORALEN-ULTRA	METHOXSALEN	10MG	CAPSULE;ORAL	Prescription	Yes	AB	019600	BAUSCH

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