Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 211998
Company: BELOTECA
Company: BELOTECA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DIAZEPAM | DIAZEPAM | 50MG/10ML (5MG/ML) | 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 |
---|---|---|---|---|---|---|---|
12/26/2019 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/211998Orig1s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
02/08/2023 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
08/10/2021 | SUPPL-6 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211998s006lbl.pdf | |
05/21/2021 | SUPPL-4 | Labeling-Patient Package Insert |
Label is not available on this site. |
||
05/21/2021 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
02/08/2021 | SUPPL-2 | Labeling-Package Insert, Labeling-Package Insert |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
08/10/2021 | SUPPL-6 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211998s006lbl.pdf |
DIAZEPAM
INJECTABLE;INJECTION; 50MG/10ML (5MG/ML)
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DIAZEPAM | DIAZEPAM | 50MG/10ML (5MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 211998 | BELOTECA |
DIAZEPAM | DIAZEPAM | 50MG/10ML (5MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 070311 | HIKMA |
DIAZEPAM | DIAZEPAM | 50MG/10ML (5MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 071583 | HOSPIRA |