Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050734
Company: PFIZER
Company: PFIZER
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
IDAMYCIN PFS | IDARUBICIN HYDROCHLORIDE | 1MG/ML | 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 |
---|---|---|---|---|---|---|---|
02/17/1997 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
11/06/2023 | SUPPL-31 | Manufacturing (CMC)-Control |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/050734Orig1s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/050734Orig1s031ltr.pdf | |
04/27/2022 | SUPPL-29 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050734s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/050734Orig1s029ltr.pdf | |
02/10/2021 | SUPPL-27 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050734s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/050734Orig1s027ltr.pdf | |
08/02/2019 | SUPPL-25 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050734s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/050734Orig1s025ltr.pdf | |
12/04/2014 | SUPPL-22 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050734s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050734Orig1s022ltr.pdf | |
11/05/2002 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
04/02/2002 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/21/2000 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
05/31/2000 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/31/2000 | SUPPL-7 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
04/07/2000 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/01/2003 | SUPPL-5 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/050734s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50734slr005ltr.pdf | |
08/12/1999 | SUPPL-4 | Labeling |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
11/06/2023 | SUPPL-31 | Manufacturing (CMC)-Control | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/050734Orig1s031lbl.pdf |
04/27/2022 | SUPPL-29 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050734s029lbl.pdf | |
02/10/2021 | SUPPL-27 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050734s027lbl.pdf | |
08/02/2019 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050734s025lbl.pdf | |
12/04/2014 | SUPPL-22 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050734s022lbl.pdf | |
05/01/2003 | SUPPL-5 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/050734s005lbl.pdf |
IDAMYCIN PFS
INJECTABLE;INJECTION; 1MG/ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
IDAMYCIN PFS | IDARUBICIN HYDROCHLORIDE | 1MG/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 050734 | PFIZER |
IDARUBICIN HYDROCHLORIDE | IDARUBICIN HYDROCHLORIDE | 1MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 065275 | HIKMA |
IDARUBICIN HYDROCHLORIDE | IDARUBICIN HYDROCHLORIDE | 1MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 065288 | HIKMA |
IDARUBICIN HYDROCHLORIDE | IDARUBICIN HYDROCHLORIDE | 1MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 065036 | MEITHEAL |