Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 214348
Company: HENGRUI PHARMA
Company: HENGRUI PHARMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BUPIVACAINE LIPOSOME | BUPIVACAINE | 133MG/10ML (13.3MG/ML) | INJECTABLE, LIPOSOMAL;INJECTION | Prescription | AP | No | No |
| BUPIVACAINE LIPOSOME | BUPIVACAINE | 266MG/20ML (13.3MG/ML) | INJECTABLE, LIPOSOMAL;INJECTION | 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 |
|---|---|---|---|---|---|---|---|
| 07/01/2024 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
BUPIVACAINE LIPOSOME
INJECTABLE, LIPOSOMAL;INJECTION; 133MG/10ML (13.3MG/ML)
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BUPIVACAINE LIPOSOME | BUPIVACAINE | 133MG/10ML (13.3MG/ML) | INJECTABLE, LIPOSOMAL;INJECTION | Prescription | No | AP | 214348 | HENGRUI PHARMA |
| EXPAREL | BUPIVACAINE | 133MG/10ML (13.3MG/ML) | INJECTABLE, LIPOSOMAL;INJECTION | Prescription | Yes | AP | 022496 | PACIRA PHARMS INC |
INJECTABLE, LIPOSOMAL;INJECTION; 266MG/20ML (13.3MG/ML)
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BUPIVACAINE LIPOSOME | BUPIVACAINE | 266MG/20ML (13.3MG/ML) | INJECTABLE, LIPOSOMAL;INJECTION | Prescription | No | AP | 214348 | HENGRUI PHARMA |
| EXPAREL | BUPIVACAINE | 266MG/20ML (13.3MG/ML) | INJECTABLE, LIPOSOMAL;INJECTION | Prescription | Yes | AP | 022496 | PACIRA PHARMS INC |