Drugs@FDA: FDA-Approved Drugs
Company: SAGENT PHARMS INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PROPOFOL | PROPOFOL | 10MG/ML | INJECTABLE;INJECTION | Prescription | AB | 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 |
---|---|---|---|---|---|---|---|
01/04/1999 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/75102_Propofol.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
12/22/2017 | SUPPL-38 | Labeling-Package Insert |
Label is not available on this site. |
||
07/05/2016 | SUPPL-35 | Labeling-Package Insert |
Label is not available on this site. |
||
11/19/2015 | SUPPL-32 | Labeling-Package Insert |
Label is not available on this site. |
||
12/18/2012 | SUPPL-28 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
02/25/2009 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
03/10/2005 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
02/08/2005 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
09/11/2002 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
09/11/2002 | SUPPL-8 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
09/11/2002 | SUPPL-7 | Manufacturing (CMC)-New Strength |
Label is not available on this site. |
||
03/06/2002 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
11/16/2000 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
02/10/2000 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
05/14/1999 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
03/23/1999 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
07/28/1999 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
PROPOFOL
INJECTABLE;INJECTION; 10MG/ML
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DIPRIVAN | PROPOFOL | 10MG/ML | INJECTABLE;INJECTION | Prescription | Yes | AB | 019627 | FRESENIUS KABI USA |
PROPOFOL | PROPOFOL | 10MG/ML | INJECTABLE;INJECTION | Prescription | No | AB | 217525 | AMNEAL |
PROPOFOL | PROPOFOL | 10MG/ML | INJECTABLE;INJECTION | Prescription | No | AB | 217013 | ASPIRO |
PROPOFOL | PROPOFOL | 10MG/ML | INJECTABLE;INJECTION | Prescription | No | AB | 206408 | AVET LIFESCIENCES |
PROPOFOL | PROPOFOL | 10MG/ML | INJECTABLE;INJECTION | Prescription | No | AB | 205067 | DR REDDYS |
PROPOFOL | PROPOFOL | 10MG/ML | INJECTABLE;INJECTION | Prescription | No | AB | 074848 | HIKMA |
PROPOFOL | PROPOFOL | 10MG/ML | INJECTABLE;INJECTION | Prescription | No | AB | 077908 | HOSPIRA |
PROPOFOL | PROPOFOL | 10MG/ML | INJECTABLE;INJECTION | Prescription | No | AB | 205576 | INNOPHARMA |
PROPOFOL | PROPOFOL | 10MG/ML | INJECTABLE;INJECTION | Prescription | No | AB | 075102 | SAGENT PHARMS INC |