Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 204607
Company: PHARMASCIENCE INC
Company: PHARMASCIENCE INC
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 |
---|---|---|---|---|---|---|---|
05/31/2017 | 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 |
---|---|---|---|---|---|
06/25/2021 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
11/10/2020 | SUPPL-3 | 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 | 214569 | EUGIA PHARMA |
DECITABINE | DECITABINE | 50MG/VIAL | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 205539 | GLAND |
DECITABINE | DECITABINE | 50MG/VIAL | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 213472 | JIANGSU HANSOH PHARM |
DECITABINE | DECITABINE | 50MG/VIAL | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 210756 | LUPIN LTD |
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 | 210984 | NOVAST LABS |
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 | 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 |