Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 216081
Company: HENGRUI PHARMA
Company: HENGRUI PHARMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| GADOBUTROL | GADOBUTROL | 18.1416GM/30ML (604.72MG/ML) | SOLUTION;INTRAVENOUS | Prescription | AP | No | No |
| GADOBUTROL | GADOBUTROL | 39.3068GM/65ML (604.72MG/ML) | SOLUTION;INTRAVENOUS | Prescription | AP | No | No |
| GADOBUTROL | GADOBUTROL | 1.20944GM/2ML (604.72MG/ML) | SOLUTION;INTRAVENOUS | Prescription | AP | No | No |
| GADOBUTROL | GADOBUTROL | 4.5354GM/7.5ML (604.72MG/ML) | SOLUTION;INTRAVENOUS | Prescription | AP | No | No |
| GADOBUTROL | GADOBUTROL | 6.0472GM/10ML (604.72MG/ML) | SOLUTION;INTRAVENOUS | Prescription | AP | No | No |
| GADOBUTROL | GADOBUTROL | 9.0708GM/15ML (604.72MG/ML) | SOLUTION;INTRAVENOUS | Prescription | AP | 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 |
|---|---|---|---|---|---|---|---|
| 09/08/2023 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/216081Orig1s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/19/2024 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
GADOBUTROL
SOLUTION;INTRAVENOUS; 18.1416GM/30ML (604.72MG/ML)
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| GADAVIST | GADOBUTROL | 18.1416GM/30ML (604.72MG/ML) | SOLUTION;INTRAVENOUS | Prescription | Yes | AP | 201277 | BAYER HLTHCARE |
| GADOBUTROL | GADOBUTROL | 18.1416GM/30ML (604.72MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 216081 | HENGRUI PHARMA |
SOLUTION;INTRAVENOUS; 39.3068GM/65ML (604.72MG/ML)
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| GADAVIST | GADOBUTROL | 39.3068GM/65ML (604.72MG/ML) | SOLUTION;INTRAVENOUS | Prescription | Yes | AP | 201277 | BAYER HLTHCARE |
| GADOBUTROL | GADOBUTROL | 39.3068GM/65ML (604.72MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 216081 | HENGRUI PHARMA |
SOLUTION;INTRAVENOUS; 1.20944GM/2ML (604.72MG/ML)
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| GADAVIST | GADOBUTROL | 1.20944GM/2ML (604.72MG/ML) | SOLUTION;INTRAVENOUS | Prescription | Yes | AP | 201277 | BAYER HLTHCARE |
| GADOBUTROL | GADOBUTROL | 1.20944GM/2ML (604.72MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 215061 | HENGRUI PHARMA |
| GADOBUTROL | GADOBUTROL | 1.20944GM/2ML (604.72MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 216081 | HENGRUI PHARMA |
SOLUTION;INTRAVENOUS; 4.5354GM/7.5ML (604.72MG/ML)
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| GADAVIST | GADOBUTROL | 4.5354GM/7.5ML (604.72MG/ML) | SOLUTION;INTRAVENOUS | Prescription | Yes | AP | 201277 | BAYER HLTHCARE |
| GADOBUTROL | GADOBUTROL | 4.5354GM/7.5ML (604.72MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 217480 | HAINAN POLY PHARM |
| GADOBUTROL | GADOBUTROL | 4.5354GM/7.5ML (604.72MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 215061 | HENGRUI PHARMA |
| GADOBUTROL | GADOBUTROL | 4.5354GM/7.5ML (604.72MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 216081 | HENGRUI PHARMA |
SOLUTION;INTRAVENOUS; 6.0472GM/10ML (604.72MG/ML)
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| GADAVIST | GADOBUTROL | 6.0472GM/10ML (604.72MG/ML) | SOLUTION;INTRAVENOUS | Prescription | Yes | AP | 201277 | BAYER HLTHCARE |
| GADOBUTROL | GADOBUTROL | 6.0472GM/10ML (604.72MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 215061 | HENGRUI PHARMA |
| GADOBUTROL | GADOBUTROL | 6.0472GM/10ML (604.72MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 216081 | HENGRUI PHARMA |
SOLUTION;INTRAVENOUS; 9.0708GM/15ML (604.72MG/ML)
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| GADAVIST | GADOBUTROL | 9.0708GM/15ML (604.72MG/ML) | SOLUTION;INTRAVENOUS | Prescription | Yes | AP | 201277 | BAYER HLTHCARE |
| GADOBUTROL | GADOBUTROL | 9.0708GM/15ML (604.72MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 217480 | HAINAN POLY PHARM |
| GADOBUTROL | GADOBUTROL | 9.0708GM/15ML (604.72MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 215061 | HENGRUI PHARMA |
| GADOBUTROL | GADOBUTROL | 9.0708GM/15ML (604.72MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 216081 | HENGRUI PHARMA |