Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021507
Company: TAKEDA PHARMS NA
Company: TAKEDA PHARMS NA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PREVACID NAPRAPAC 250 (COPACKAGED) | LANSOPRAZOLE; NAPROXEN | 15MG,N/A;N/A,250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, DELAYED REL PELLETS, TABLET;ORAL | Discontinued | None | Yes | No |
PREVACID NAPRAPAC 375 (COPACKAGED) | LANSOPRAZOLE; NAPROXEN | 15MG,N/A;N/A,375MG | CAPSULE, DELAYED REL PELLETS, TABLET;ORAL | Discontinued | None | No | No |
PREVACID NAPRAPAC 500 (COPACKAGED) | LANSOPRAZOLE; NAPROXEN | 15MG,N/A;N/A,500MG | CAPSULE, DELAYED REL PELLETS, TABLET;ORAL | Discontinued | None | 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 |
---|---|---|---|---|---|---|---|
11/14/2003 | ORIG-1 | Approval | Type 4 - New Combination | STANDARD |
Letter (PDF)
Review |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21507ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21507_PrevacidTOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
07/31/2009 | SUPPL-9 |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021507s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021507s009ltr.pdf | ||
10/20/2008 | SUPPL-8 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021507s008ltr.pdf |
08/31/2006 | SUPPL-7 | Labeling |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021507s005,007lbl.pdf | |
08/31/2006 | SUPPL-5 | Labeling |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021507s005,007lbl.pdf | |
04/12/2006 | SUPPL-4 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021507s004ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
07/31/2009 | SUPPL-9 | Supplement | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021507s009lbl.pdf | |
08/31/2006 | SUPPL-7 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021507s005,007lbl.pdf | |
08/31/2006 | SUPPL-5 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021507s005,007lbl.pdf |