Drugs@FDA: FDA-Approved Drugs
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 | 202687 | STRIDES PHARMA |
OXSORALEN-ULTRA | METHOXSALEN | 10MG | CAPSULE;ORAL | Prescription | Yes | AB | 019600 | BAUSCH |