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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 010515
Company: BAUSCH

View In-Use Labeling

Products on NDA 010515

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 010515

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.

Labels for NDA 010515

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

Therapeutic Equivalents for NDA 010515

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	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	211703	HIKMA
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
ISOPROTERENOL HYDROCHLORIDE	ISOPROTERENOL HYDROCHLORIDE	0.2MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	215557	ZYDUS PHARMS
ISUPREL	ISOPROTERENOL HYDROCHLORIDE	0.2MG/ML	INJECTABLE;INJECTION	Prescription	Yes	AP	010515	BAUSCH

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