Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 072945
Company: HOSPIRA
Company: HOSPIRA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CYTARABINE | CYTARABINE | 20MG/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 |
|---|---|---|---|---|---|---|---|
| 02/28/1994 | 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 |
|---|---|---|---|---|---|
| 06/02/2020 | SUPPL-25 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/15/2019 | SUPPL-24 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 10/03/2018 | SUPPL-22 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 10/03/2018 | SUPPL-20 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 11/18/2003 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 05/14/2001 | SUPPL-10 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 08/08/2000 | SUPPL-8 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 05/18/2000 | SUPPL-7 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 05/12/2000 | SUPPL-6 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 06/03/1997 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 04/28/1995 | SUPPL-2 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 09/21/1994 | SUPPL-1 | Labeling |
Label is not available on this site. |
CYTARABINE
INJECTABLE;INJECTION; 20MG/ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CYTARABINE | CYTARABINE | 20MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 071868 | HOSPIRA |
| CYTARABINE | CYTARABINE | 20MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 072168 | HOSPIRA |
| CYTARABINE | CYTARABINE | 20MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 072945 | HOSPIRA |
| CYTARABINE | CYTARABINE | 20MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 208485 | MEITHEAL |
| CYTARABINE | CYTARABINE | 20MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 200915 | RISING |