Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 217987
Company: CIPLA

Products on ANDA 217987

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VASOPRESSIN	VASOPRESSIN	20UNITS/100ML (0.2UNITS/ML)	SOLUTION;INTRAVENOUS	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 217987

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/06/2023	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/217987Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 217987

VASOPRESSIN

SOLUTION;INTRAVENOUS; 20UNITS/100ML (0.2UNITS/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
VASOPRESSIN	VASOPRESSIN	20UNITS/100ML (0.2UNITS/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	217987	CIPLA
VASOSTRICT	VASOPRESSIN	20UNITS/100ML (0.2UNITS/ML)	SOLUTION;INTRAVENOUS	Prescription	Yes	AP	204485	PAR STERILE PRODUCTS