اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است
CARMUSTINE از شرکت NAVINTA LLC
Abbreviated New Drug Application (ANDA): 210179
Company: NAVINTA LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CARMUSTINE | CARMUSTINE | 100MG/VIAL | INJECTABLE;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 |
|---|---|---|---|---|---|---|---|
| 09/11/2018 | ORIG-1 | Approval |
STANDARD |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210179Orig1s000Ltr.pdf |
CARMUSTINE
INJECTABLE;INJECTION; 100MG/VIAL
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BICNU | CARMUSTINE | 100MG/VIAL | INJECTABLE;INJECTION | Prescription | Yes | AP | 017422 | AVET LIFESCIENCES |
| CARMUSTINE | CARMUSTINE | 100MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 211229 | AMNEAL |
| CARMUSTINE | CARMUSTINE | 100MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 213207 | DR REDDYS |
| CARMUSTINE | CARMUSTINE | 100MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 211202 | JIANGSU HENGRUI MED |
| CARMUSTINE | CARMUSTINE | 100MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 213460 | MEITHEAL |
| CARMUSTINE | CARMUSTINE | 100MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 210179 | NAVINTA LLC |
| CARMUSTINE | CARMUSTINE | 100MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 209278 | STI PHARMA LLC |
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