Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 203475
Company: ACCORD HLTHCARE
Company: ACCORD HLTHCARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DECITABINE | DECITABINE | 50MG/VIAL | INJECTABLE;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 |
|---|---|---|---|---|---|---|---|
| 02/27/2017 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/01/2025 | SUPPL-7 | Labeling, Labeling-Medication Guide, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 09/29/2021 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/29/2021 | SUPPL-2 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 09/29/2021 | SUPPL-1 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
DECITABINE
INJECTABLE;INTRAVENOUS; 50MG/VIAL
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DECITABINE | DECITABINE | 50MG/VIAL | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 203475 | ACCORD HLTHCARE |
| DECITABINE | DECITABINE | 50MG/VIAL | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 206033 | CHEMI SPA |
| DECITABINE | DECITABINE | 50MG/VIAL | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 203131 | DR REDDYS |
| DECITABINE | DECITABINE | 50MG/VIAL | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 205539 | GLAND |
| DECITABINE | DECITABINE | 50MG/VIAL | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 215355 | HETERO LABS LTD VI |
| DECITABINE | DECITABINE | 50MG/VIAL | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 213472 | JIANGSU HANSOH PHARM |
| DECITABINE | DECITABINE | 50MG/VIAL | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 212959 | MEITHEAL |
| DECITABINE | DECITABINE | 50MG/VIAL | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 212265 | MSN |
| DECITABINE | DECITABINE | 50MG/VIAL | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 212117 | NIVAGEN PHARMS INC |
| DECITABINE | DECITABINE | 50MG/VIAL | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 204607 | PHARMASCIENCE INC |
| DECITABINE | DECITABINE | 50MG/VIAL | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 212826 | QILU PHARM HAINAN |
| DECITABINE | DECITABINE | 50MG/VIAL | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 217814 | RELIANCE LIFE SCI |
| DECITABINE | DECITABINE | 50MG/VIAL | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 207100 | SAGENT PHARMS INC |
| DECITABINE | DECITABINE | 50MG/VIAL | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 202969 | SANDOZ |
| DECITABINE | DECITABINE | 50MG/VIAL | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 209056 | WOCKHARDT BIO AG |
| DECITABINE | DECITABINE | 50MG/VIAL | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 214486 | ZYDUS PHARMS |