Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 008578
Company: TILDE SCIENCES
Company: TILDE SCIENCES
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DARAPRIM | PYRIMETHAMINE | 25MG | TABLET;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 |
---|---|---|---|---|---|---|---|
01/23/1953 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/pre96/008578s020lbl.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
06/21/2017 | SUPPL-20 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/008578s020lbl.pdf | |
03/16/2017 | SUPPL-19 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/008578s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/008578Orig1s019ltr.pdf | |
11/18/2003 | SUPPL-16 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/08578slr016_daraprim_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/08578slr016ltr.pdf | |
10/10/2002 | SUPPL-15 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/8578s15lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/8578slr015ltr.pdf | |
04/08/1998 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
03/25/1997 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
04/08/1998 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
10/17/1988 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
02/20/1987 | SUPPL-8 | Labeling |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
06/21/2017 | SUPPL-20 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/008578s020lbl.pdf | |
03/16/2017 | SUPPL-19 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/008578s019lbl.pdf | |
11/18/2003 | SUPPL-16 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/08578slr016_daraprim_lbl.pdf | |
10/10/2002 | SUPPL-15 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/8578s15lbl.pdf | |
01/23/1953 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/pre96/008578s020lbl.pdf |
DARAPRIM
TABLET;ORAL; 25MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DARAPRIM | PYRIMETHAMINE | 25MG | TABLET;ORAL | Prescription | Yes | AB | 008578 | TILDE SCIENCES |
PYRIMETHAMINE | PYRIMETHAMINE | 25MG | TABLET;ORAL | Prescription | No | AB | 211271 | ALVOGEN |
PYRIMETHAMINE | PYRIMETHAMINE | 25MG | TABLET;ORAL | Prescription | No | AB | 216983 | AUROBINDO PHARMA LTD |
PYRIMETHAMINE | PYRIMETHAMINE | 25MG | TABLET;ORAL | Prescription | No | AB | 207127 | SANALUZ |
PYRIMETHAMINE | PYRIMETHAMINE | 25MG | TABLET;ORAL | Prescription | No | AB | 215506 | TEVA PHARMS |