Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 205576
Company: INNOPHARMA
Company: INNOPHARMA
| 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 |
|---|---|---|---|---|---|---|---|
| 09/16/2020 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/31/2023 | SUPPL-1 | Labeling-Package Insert |
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 | 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 |