Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 210363
Company: BELOTECA
Company: BELOTECA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DIAZEPAM | DIAZEPAM | 10MG/2ML (5MG/ML) | INJECTABLE;INJECTION | Prescription | AP | No | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
03/18/2019 | 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 |
---|---|---|---|---|---|
01/11/2023 | SUPPL-10 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
02/08/2023 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
03/23/2022 | SUPPL-7 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/210363s007lbl.pdf | |
06/23/2021 | SUPPL-6 | Labeling-Patient Package Insert |
Label is not available on this site. |
||
06/23/2021 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
02/08/2021 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
11/06/2019 | SUPPL-1 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
03/23/2022 | SUPPL-7 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/210363s007lbl.pdf |
DIAZEPAM
INJECTABLE;INJECTION; 10MG/2ML (5MG/ML)
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DIAZEPAM | DIAZEPAM | 10MG/2ML (5MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 218450 | ALEMBIC |
DIAZEPAM | DIAZEPAM | 10MG/2ML (5MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 210363 | BELOTECA |
DIAZEPAM | DIAZEPAM | 10MG/2ML (5MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 218422 | DR REDDYS |
DIAZEPAM | DIAZEPAM | 10MG/2ML (5MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 214745 | FRESENIUS KABI USA |
DIAZEPAM | DIAZEPAM | 10MG/2ML (5MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 070313 | HIKMA |
DIAZEPAM | DIAZEPAM | 10MG/2ML (5MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 072079 | HOSPIRA |