Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 016796
Company: RISING

Products on NDA 016796

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
INAPSINE	DROPERIDOL	2.5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	INJECTABLE;INJECTION	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 016796

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/11/1970	ORIG-1	Approval	Type 3 - New Dosage Form	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
11/26/2001	SUPPL-39	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/16796s39ltr.pdf
12/14/2000	SUPPL-37	Manufacturing (CMC)-Packaging		Label is not available on this site.
04/12/2000	SUPPL-36	Manufacturing (CMC)-Control		Label is not available on this site.
02/18/2000	SUPPL-35	Labeling		Label is not available on this site.
09/29/1998	SUPPL-34	Manufacturing (CMC)-Packaging		Label is not available on this site.
02/22/1995	SUPPL-33	Manufacturing (CMC)		Label is not available on this site.
03/15/1995	SUPPL-32	Manufacturing (CMC)-Control		Label is not available on this site.
03/02/1994	SUPPL-30	Labeling		Label is not available on this site.
06/29/1994	SUPPL-29	Manufacturing (CMC)-Control		Label is not available on this site.
10/28/1992	SUPPL-28	Manufacturing (CMC)		Label is not available on this site.
10/05/1990	SUPPL-27	Manufacturing (CMC)-Control		Label is not available on this site.
07/17/1987	SUPPL-26	Manufacturing (CMC)		Label is not available on this site.
12/06/1988	SUPPL-25	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
12/15/1986	SUPPL-24	Labeling		Label is not available on this site.
12/15/1986	SUPPL-23	Manufacturing (CMC)-Control		Label is not available on this site.
04/02/1987	SUPPL-22	Labeling		Label is not available on this site.
03/15/1985	SUPPL-21	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
12/31/1987	SUPPL-20	Labeling		Label is not available on this site.
12/31/1987	SUPPL-19	Manufacturing (CMC)-Control		Label is not available on this site.
08/13/1982	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
01/20/1982	SUPPL-14	Manufacturing (CMC)-Control		Label is not available on this site.
07/28/1982	SUPPL-13	Labeling		Label is not available on this site.
07/28/1982	SUPPL-12	Manufacturing (CMC)-Control		Label is not available on this site.
05/23/1980	SUPPL-10	Manufacturing (CMC)-Control		Label is not available on this site.
11/08/1976	SUPPL-8	Manufacturing (CMC)-Control		Label is not available on this site.
08/29/1974	SUPPL-5	Labeling		Label is not available on this site.