Drugs@FDA: FDA-Approved Drugs
Company: GLAXOSMITHKLINE LLC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
FLOLAN | EPOPROSTENOL SODIUM | EQ 0.5MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | AP1 | Yes | Yes |
FLOLAN | EPOPROSTENOL SODIUM | EQ 1.5MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | AP1 | 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 |
---|---|---|---|---|---|---|---|
09/20/1995 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY; Orphan |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020444Orig1s000rev.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
08/24/2021 | SUPPL-25 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020444s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020444Orig1s025ltr.pdf | |
12/12/2018 | SUPPL-24 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020444s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020444Orig1s024ltr.pdf | |
10/23/2018 | SUPPL-23 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020444s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020444Orig1s023ltr.pdf | |
05/14/2018 | SUPPL-22 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020444s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020444Orig1s022ltr.pdf | |
04/17/2015 | SUPPL-21 | Manufacturing (CMC) |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020444s021lbl.pdf | |
03/29/2011 | SUPPL-18 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020444s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020444s018ltr.pdf | |
03/12/2008 | SUPPL-16 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020444s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020444s016ltr.pdf | |
09/20/2002 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/21/2002 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/21/2002 | SUPPL-8 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
04/05/2002 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/17/2002 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/21/2000 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
11/02/1999 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
04/14/2000 | SUPPL-3 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20444S03LBL.PDF https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20444S03LTR.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-444S003_Flolan.cfm | |
11/21/1997 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/18/1996 | SUPPL-1 | Labeling |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
08/24/2021 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020444s025lbl.pdf | |
08/24/2021 | SUPPL-25 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020444s025lbl.pdf | |
12/12/2018 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020444s024lbl.pdf | |
10/23/2018 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020444s023lbl.pdf | |
05/14/2018 | SUPPL-22 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020444s022lbl.pdf | |
04/17/2015 | SUPPL-21 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020444s021lbl.pdf |
03/29/2011 | SUPPL-18 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020444s018lbl.pdf | |
03/12/2008 | SUPPL-16 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020444s016lbl.pdf | |
04/14/2000 | SUPPL-3 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20444S03LBL.PDF |
FLOLAN
INJECTABLE;INJECTION; EQ 0.5MG BASE/VIAL
TE Code = AP1
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
EPOPROSTENOL SODIUM | EPOPROSTENOL SODIUM | EQ 0.5MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP1 | 078396 | MEITHEAL |
FLOLAN | EPOPROSTENOL SODIUM | EQ 0.5MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | Yes | AP1 | 020444 | GLAXOSMITHKLINE LLC |
INJECTABLE;INJECTION; EQ 1.5MG BASE/VIAL
TE Code = AP1
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
EPOPROSTENOL SODIUM | EPOPROSTENOL SODIUM | EQ 1.5MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP1 | 078396 | MEITHEAL |
FLOLAN | EPOPROSTENOL SODIUM | EQ 1.5MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | Yes | AP1 | 020444 | GLAXOSMITHKLINE LLC |