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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 083722
Company: INTL MEDICATION

Products on ANDA 083722

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PHYTONADIONE	PHYTONADIONE	1MG/0.5ML	INJECTABLE;INJECTION	Prescription	BP	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 083722

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/01/1976	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/23/2023	SUPPL-34	Manufacturing (CMC)-Packaging	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/083722Orig1s029,s031,s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/083722Orig1s029,s031,s034ltr.pdf
10/23/2023	SUPPL-31	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/083722Orig1s029,s031,s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/083722Orig1s029,s031,s034ltr.pdf
10/23/2023	SUPPL-29	Labeling-Package Insert, Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/083722Orig1s029,s031,s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/083722Orig1s029,s031,s034ltr.pdf
04/18/2003	SUPPL-23	Labeling		Label is not available on this site.
03/06/2002	SUPPL-21	Labeling		Label is not available on this site.
01/04/2001	SUPPL-20	Manufacturing (CMC)-Control		Label is not available on this site.
09/19/1995	SUPPL-19	Manufacturing (CMC)		Label is not available on this site.
11/10/1994	SUPPL-18	Labeling		Label is not available on this site.
06/17/1994	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
01/14/1998	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
02/03/1994	SUPPL-14	Labeling		Label is not available on this site.
10/29/1993	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
08/30/1993	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
12/09/1992	SUPPL-11	Labeling	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/083722Orig1s011.pdf
08/05/1987	SUPPL-9	Manufacturing (CMC)	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/083722Orig1s009.pdf
07/11/2000	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.

Labels for ANDA 083722

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/23/2023	SUPPL-34	Manufacturing (CMC)-Packaging	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/083722Orig1s029,s031,s034lbl.pdf
10/23/2023	SUPPL-31	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/083722Orig1s029,s031,s034lbl.pdf
10/23/2023	SUPPL-29	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/083722Orig1s029,s031,s034lbl.pdf
10/23/2023	SUPPL-29	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/083722Orig1s029,s031,s034lbl.pdf

Therapeutic Equivalents for ANDA 083722

PHYTONADIONE

There are no Therapeutic Equivalents.

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