Drugs@FDA: FDA-Approved Drugs
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 |
---|---|---|---|---|---|---|---|
06/04/1990 | 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-32 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/071868s032lbl.pdf | |
01/15/2019 | SUPPL-31 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
01/15/2019 | SUPPL-30 | Labeling-Package Insert |
Label is not available on this site. |
||
01/15/2019 | SUPPL-29 | Labeling-Package Insert |
Label is not available on this site. |
||
05/14/2001 | SUPPL-17 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
08/08/2000 | SUPPL-15 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
05/18/2000 | SUPPL-14 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
05/12/2000 | SUPPL-13 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
03/28/1998 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/02/1997 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
04/16/1997 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/28/1995 | SUPPL-7 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
05/23/1994 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/23/1994 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
03/25/1991 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/28/1993 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/15/1991 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
12/31/1990 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
06/02/2020 | SUPPL-32 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/071868s032lbl.pdf |
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 |