Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020122
Company: HOSPIRA INC
Company: HOSPIRA INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NIPENT | PENTOSTATIN | 10MG/VIAL | INJECTABLE;INJECTION | Prescription | AP | Yes | 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 |
---|---|---|---|---|---|---|---|
10/11/1991 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY; Orphan |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
10/28/2019 | SUPPL-15 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020122s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020122Orig1s015ltr.pdf | |
12/29/2015 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/20/2013 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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09/22/2009 | SUPPL-10 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
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05/23/2002 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
08/02/2001 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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10/08/1998 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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12/24/1997 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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07/19/1994 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
09/29/1993 | SUPPL-1 | Efficacy-New Indication |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
10/28/2019 | SUPPL-15 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020122s015lbl.pdf |
NIPENT
INJECTABLE;INJECTION; 10MG/VIAL
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
NIPENT | PENTOSTATIN | 10MG/VIAL | INJECTABLE;INJECTION | Prescription | Yes | AP | 020122 | HOSPIRA INC |
PENTOSTATIN | PENTOSTATIN | 10MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 077841 | WEST-WARD PHARMS INT |