Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022137
Company: CAPLIN ONE LABS
Company: CAPLIN ONE LABS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FLUDARABINE PHOSPHATE | FLUDARABINE PHOSPHATE | 50MG/2ML (25MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 09/21/2007 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022137lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022137s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022137_fludarabine_toc.html |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/19/2024 | SUPPL-15 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022137Orig1s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/022137Orig1s015ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/022137Orig1s015MultidisciplineR.pdf | |
| 05/17/2016 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/12/2015 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/29/2014 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/10/2016 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/25/2014 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/25/2014 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/25/2014 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/18/2011 | SUPPL-3 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022137s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022137s003ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 11/19/2024 | SUPPL-15 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022137Orig1s015lbl.pdf | |
| 02/18/2011 | SUPPL-3 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022137s003lbl.pdf | |
| 09/21/2007 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022137lbl.pdf |