Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074848
Company: HIKMA
Company: HIKMA
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 |
---|---|---|---|---|---|---|---|
04/19/2005 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/074848ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
08/30/2023 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
||
07/16/2020 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
07/16/2020 | SUPPL-7 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
07/16/2020 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
01/02/2008 | SUPPL-4 | Labeling |
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 |