Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 207518
Company: SHILPA MEDICARE
Company: SHILPA MEDICARE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
AZACITIDINE | AZACITIDINE | 100MG/VIAL | POWDER;INTRAVENOUS, SUBCUTANEOUS | 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 |
---|---|---|---|---|---|---|---|
09/29/2016 | 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 |
---|---|---|---|---|---|
08/06/2020 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
03/25/2019 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
AZACITIDINE
POWDER;INTRAVENOUS, SUBCUTANEOUS; 100MG/VIAL
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
AZACITIDINE | AZACITIDINE | 100MG/VIAL | POWDER;INTRAVENOUS, SUBCUTANEOUS | Prescription | No | AP | 207475 | ACCORD HLTHCARE |
AZACITIDINE | AZACITIDINE | 100MG/VIAL | POWDER;INTRAVENOUS, SUBCUTANEOUS | Prescription | No | AP | 208216 | ACTAVIS LLC |
AZACITIDINE | AZACITIDINE | 100MG/VIAL | POWDER;INTRAVENOUS, SUBCUTANEOUS | Prescription | No | AP | 211549 | AMNEAL |
AZACITIDINE | AZACITIDINE | 100MG/VIAL | POWDER;INTRAVENOUS, SUBCUTANEOUS | Prescription | No | AP | 209540 | CIPLA |
AZACITIDINE | AZACITIDINE | 100MG/VIAL | POWDER;INTRAVENOUS, SUBCUTANEOUS | Prescription | No | AP | 201537 | DR REDDYS |
AZACITIDINE | AZACITIDINE | 100MG/VIAL | POWDER;INTRAVENOUS, SUBCUTANEOUS | Prescription | No | AP | 215066 | EUGIA PHARMA |
AZACITIDINE | AZACITIDINE | 100MG/VIAL | POWDER;INTRAVENOUS, SUBCUTANEOUS | Prescription | No | AP | 209337 | EUROHLTH INTL SARL |
AZACITIDINE | AZACITIDINE | 100MG/VIAL | POWDER;INTRAVENOUS, SUBCUTANEOUS | Prescription | No | AP | 215905 | JIANGSU HANSOH PHARM |
AZACITIDINE | AZACITIDINE | 100MG/VIAL | POWDER;INTRAVENOUS, SUBCUTANEOUS | Prescription | No | AP | 212128 | MEITHEAL |
AZACITIDINE | AZACITIDINE | 100MG/VIAL | POWDER;INTRAVENOUS, SUBCUTANEOUS | Prescription | No | AP | 212580 | MSN LABS PVT LTD |
AZACITIDINE | AZACITIDINE | 100MG/VIAL | POWDER;INTRAVENOUS, SUBCUTANEOUS | Prescription | No | AP | 207234 | NATCO PHARMA LTD |
AZACITIDINE | AZACITIDINE | 100MG/VIAL | POWDER;INTRAVENOUS, SUBCUTANEOUS | Prescription | No | AP | 207518 | SHILPA MEDICARE |
VIDAZA | AZACITIDINE | 100MG/VIAL | POWDER;INTRAVENOUS, SUBCUTANEOUS | Prescription | Yes | AP | 050794 | BRISTOL-MYERS |