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New Drug Application (NDA): 010515
Company: BAUSCH
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ISUPREL ISOPROTERENOL HYDROCHLORIDE 0.2MG/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
05/25/1956 ORIG-1 Approval Type 3 - New Dosage Form PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/20/2022 SUPPL-33 Labeling-Container/Carton Labels, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/010515Orig1s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/010515Orig1s033ltr.pdf
03/21/2013 SUPPL-31 Manufacturing (CMC) Label (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/010515s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/010515Orig1s031.pdf
07/18/2001 SUPPL-24 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/010515Orig1s024.pdf
02/23/2000 SUPPL-23 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/010515Orig1s023.pdf
05/04/1999 SUPPL-22 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/10515s22lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/10515s22ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/10515s022_Isuprel.pdf
02/14/1996 SUPPL-21 Labeling

Label is not available on this site.

03/09/1992 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

02/14/1996 SUPPL-19 Labeling

Label is not available on this site.

02/06/1989 SUPPL-18 Labeling

Label is not available on this site.

07/24/1987 SUPPL-17 Labeling

Label is not available on this site.

12/08/1987 SUPPL-16 Labeling

Label is not available on this site.

09/26/1984 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

10/08/1986 SUPPL-14 Labeling

Label is not available on this site.

08/11/1978 SUPPL-13 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

08/04/1978 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

09/05/1979 SUPPL-11 Labeling

Label is not available on this site.

10/08/1986 SUPPL-7 Efficacy-New Indication

Label is not available on this site.

02/06/1974 SUPPL-6 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/20/2022 SUPPL-33 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/010515Orig1s033lbl.pdf
10/20/2022 SUPPL-33 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/010515Orig1s033lbl.pdf
03/21/2013 SUPPL-31 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/010515s031lbl.pdf
05/04/1999 SUPPL-22 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/10515s22lbl.pdf

ISUPREL

INJECTABLE;INJECTION; 0.2MG/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ISOPROTERENOL HYDROCHLORIDE ISOPROTERENOL HYDROCHLORIDE 0.2MG/ML INJECTABLE;INJECTION Prescription No AP 214775 AM REGENT
ISOPROTERENOL HYDROCHLORIDE ISOPROTERENOL HYDROCHLORIDE 0.2MG/ML INJECTABLE;INJECTION Prescription No AP 210576 AMNEAL
ISOPROTERENOL HYDROCHLORIDE ISOPROTERENOL HYDROCHLORIDE 0.2MG/ML INJECTABLE;INJECTION Prescription No AP 210106 AMPHASTAR PHARMS INC
ISOPROTERENOL HYDROCHLORIDE ISOPROTERENOL HYDROCHLORIDE 0.2MG/ML INJECTABLE;INJECTION Prescription No AP 211237 AMRING PHARMS
ISOPROTERENOL HYDROCHLORIDE ISOPROTERENOL HYDROCHLORIDE 0.2MG/ML INJECTABLE;INJECTION Prescription No AP 212189 AVET LIFESCIENCES
ISOPROTERENOL HYDROCHLORIDE ISOPROTERENOL HYDROCHLORIDE 0.2MG/ML INJECTABLE;INJECTION Prescription No AP 210322 CIPLA
ISOPROTERENOL HYDROCHLORIDE ISOPROTERENOL HYDROCHLORIDE 0.2MG/ML INJECTABLE;INJECTION Prescription No AP 211864 EUGIA PHARMA
ISOPROTERENOL HYDROCHLORIDE ISOPROTERENOL HYDROCHLORIDE 0.2MG/ML INJECTABLE;INJECTION Prescription No AP 210845 MICRO LABS
ISOPROTERENOL HYDROCHLORIDE ISOPROTERENOL HYDROCHLORIDE 0.2MG/ML INJECTABLE;INJECTION Prescription No AP 212573 MYLAN LABS LTD
ISOPROTERENOL HYDROCHLORIDE ISOPROTERENOL HYDROCHLORIDE 0.2MG/ML INJECTABLE;INJECTION Prescription No AP 206961 NEXUS PHARMS
ISOPROTERENOL HYDROCHLORIDE ISOPROTERENOL HYDROCHLORIDE 0.2MG/ML INJECTABLE;INJECTION Prescription No AP 215542 STI PHARMA LLC
ISUPREL ISOPROTERENOL HYDROCHLORIDE 0.2MG/ML INJECTABLE;INJECTION Prescription Yes AP 010515 BAUSCH
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