Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020500
Company: GLAXOSMITHKLINE LLC
Company: GLAXOSMITHKLINE LLC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MEPRON | ATOVAQUONE | 750MG/5ML | SUSPENSION;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 |
---|---|---|---|---|---|---|---|
02/08/1995 | ORIG-1 | Approval | Type 3 - New Dosage Form | PRIORITY |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
07/18/2019 | SUPPL-19 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020500s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020500Orig1s019ltr.pdf | |
02/22/2019 | SUPPL-17 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020500s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020500Orig1s017ltr.pdf | |
10/15/2017 | SUPPL-16 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/20500s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020500Orig1s016ltr.pdf | |
06/04/2015 | SUPPL-15 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020500s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020500Orig1s015ltr.pdf | |
03/01/2013 | SUPPL-14 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020500s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020500Orig1s014ltr.pdf | |
05/07/2008 | SUPPL-10 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020500s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020500s010ltr.pdf | |
01/05/1999 | SUPPL-5 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20-500-S005.PDF https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20500s5ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020500S005.cfm | |
09/14/1998 | SUPPL-4 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
08/12/1997 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/02/1997 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
04/28/1995 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
07/18/2019 | SUPPL-19 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020500s019lbl.pdf | |
02/22/2019 | SUPPL-17 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020500s017lbl.pdf | |
10/15/2017 | SUPPL-16 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/20500s016lbl.pdf | |
10/15/2017 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/20500s016lbl.pdf | |
06/04/2015 | SUPPL-15 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020500s015lbl.pdf | |
03/01/2013 | SUPPL-14 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020500s014lbl.pdf | |
05/07/2008 | SUPPL-10 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020500s010lbl.pdf | |
01/05/1999 | SUPPL-5 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20-500-S005.PDF |
MEPRON
SUSPENSION;ORAL; 750MG/5ML
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ATOVAQUONE | ATOVAQUONE | 750MG/5ML | SUSPENSION;ORAL | Prescription | No | AB | 210510 | ABHAI LLC |
ATOVAQUONE | ATOVAQUONE | 750MG/5ML | SUSPENSION;ORAL | Prescription | No | AB | 214272 | ABON PHARMS LLC |
ATOVAQUONE | ATOVAQUONE | 750MG/5ML | SUSPENSION;ORAL | Prescription | No | AB | 202960 | AMNEAL PHARMS |
ATOVAQUONE | ATOVAQUONE | 750MG/5ML | SUSPENSION;ORAL | Prescription | No | AB | 209750 | APOTEX |
ATOVAQUONE | ATOVAQUONE | 750MG/5ML | SUSPENSION;ORAL | Prescription | No | AB | 212918 | BIONPHARMA |
ATOVAQUONE | ATOVAQUONE | 750MG/5ML | SUSPENSION;ORAL | Prescription | No | AB | 207833 | CHARTWELL RX |
ATOVAQUONE | ATOVAQUONE | 750MG/5ML | SUSPENSION;ORAL | Prescription | No | AB | 209685 | GLENMARK PHARMS |
ATOVAQUONE | ATOVAQUONE | 750MG/5ML | SUSPENSION;ORAL | Prescription | No | AB | 210692 | HETERO LABS LTD III |
ATOVAQUONE | ATOVAQUONE | 750MG/5ML | SUSPENSION;ORAL | Prescription | No | AB | 209105 | LUPIN LTD |
MEPRON | ATOVAQUONE | 750MG/5ML | SUSPENSION;ORAL | Prescription | Yes | AB | 020500 | GLAXOSMITHKLINE LLC |