Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 201537
Company: DR REDDYS
Company: DR REDDYS
| 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 |
|---|---|---|---|---|---|---|---|
| 09/16/2013 | ORIG-1 | Approval | Not Applicable |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/201537Orig1s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/22/2020 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/09/2019 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/28/2017 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/28/2017 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/28/2017 | SUPPL-2 | 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 | 215765 | HETERO LABS LTD VI |
| 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 | 217453 | RELIANCE LIFE |
| 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 |