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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017972
Company: SUN PHARM INDS INC

Products on NDA 017972

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OSTEOLITE	TECHNETIUM TC-99M MEDRONATE KIT	N/A	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 017972

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/16/1977	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	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
05/22/2025	SUPPL-17	Labeling-Package Insert	Label (PDF) Letter (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/017972s017,018124s032,019039s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/017972Orig1s017,018124Orig1s032,019039Orig1s022ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/017972Orig1s017,018124Orig1s032,019039Orig1s022ltr.pdf
07/30/2002	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
03/10/2000	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
04/04/1991	SUPPL-13	Manufacturing (CMC)-Packaging		Label is not available on this site.
05/02/1989	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
04/03/1989	SUPPL-11	Labeling		Label is not available on this site.
01/07/1985	SUPPL-9	Manufacturing (CMC)-Control		Label is not available on this site.
06/19/1984	SUPPL-8	Labeling		Label is not available on this site.
04/30/1979	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
05/08/1980	SUPPL-3	Labeling		Label is not available on this site.
05/07/1979	SUPPL-2	Labeling		Label is not available on this site.
11/13/1978	SUPPL-1	Labeling		Label is not available on this site.

Labels for NDA 017972

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/22/2025	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/017972s017,018124s032,019039s022lbl.pdf

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