Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075383
Company: HOSPIRA
Company: HOSPIRA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CYTARABINE | CYTARABINE | 100MG/ML | INJECTABLE;INJECTION | 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 |
---|---|---|---|---|---|---|---|
11/22/1999 | ORIG-1 | Approval |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75383ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/075383.PDF |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
06/02/2020 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
||
01/15/2019 | SUPPL-17 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
10/03/2018 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
||
05/14/2001 | SUPPL-4 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
11/28/2000 | SUPPL-2 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
10/17/2000 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
CYTARABINE
INJECTABLE;INJECTION; 100MG/ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CYTARABINE | CYTARABINE | 100MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 076512 | FRESENIUS KABI USA |
CYTARABINE | CYTARABINE | 100MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 075383 | HOSPIRA |
CYTARABINE | CYTARABINE | 100MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 205696 | MEITHEAL |
CYTARABINE | CYTARABINE | 100MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 201784 | RISING |