Imipramine Hydrochloride

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history

Approved	Application	Sponsor	Supplements	Marketing
Apr 16, 1959	PresamineNDA 11836 · New molecular entity	Sanofi Aventis US	22	Discontinued
Oct 2, 1959	TofranilNDA 11838 · New dosage form	Novartis	12	Discontinued
Jun 27, 1974	Imipramine HydrochlorideANDA 83729	Teva	38	Discontinued
Nov 15, 1974	JanimineNDA 17895 · TYPE 6	Abbott	8	Discontinued
Apr 20, 1976	Imipramine HydrochlorideANDA 83745	Sandoz	36	Marketed
Apr 20, 1976	Imipramine HydrochlorideANDA 84937	Sandoz	42	Marketed
Apr 20, 1976	Imipramine HydrochlorideANDA 84936	Sandoz	30	Marketed
Aug 5, 1977	Imipramine HydrochlorideANDA 83799	Roxane	3	Discontinued
Jun 19, 1978	PramineANDA 83827	Alra	0	Discontinued
Oct 16, 1978	Imipramine HydrochlorideANDA 85878	Watson Labs	0	Discontinued
Oct 30, 1978	Imipramine HydrochlorideANDA 85877	Watson Labs	0	Discontinued
Feb 4, 1981	Imipramine HydrochlorideANDA 85875	Watson Labs	0	Discontinued
Mar 13, 1981	Imipramine HydrochlorideANDA 85133	Sandoz	4	Discontinued
Mar 13, 1981	Imipramine HydrochlorideANDA 85200	Sandoz	8	Discontinued
Jan 4, 1982	Imipramine HydrochlorideANDA 87631	Vangard	0	Discontinued
Feb 9, 1982	Imipramine HydrochlorideANDA 87619	Vangard	1	Discontinued
Feb 10, 1982	Imipramine HydrochlorideANDA 87776	Usl Pharma	2	Discontinued
Nov 3, 1982	Imipramine HydrochlorideANDA 88036	Vangard	0	Discontinued
Oct 21, 1983	Imipramine HydrochlorideANDA 88262	Strides Pharma Intl	25	Marketed
Oct 21, 1983	Imipramine HydrochlorideANDA 88276	Strides Pharma Intl	26	Marketed
Oct 21, 1983	Imipramine HydrochlorideANDA 88292	Strides Pharma Intl	26	Marketed
May 22, 1984	Tofranil, Imipramine HydrochlorideANDA 87846	Specgx LLC	21	Discontinued
Jul 14, 1987	Imipramine HydrochlorideANDA 89422	Par Pharm	10	Discontinued
Jul 14, 1987	Imipramine HydrochlorideANDA 89497	Par Pharm	10	Discontinued
Jun 5, 1990	Imipramine HydrochlorideANDA 81048	Sun Pharm Industries	20	Discontinued
Jun 5, 1990	Imipramine HydrochlorideANDA 81049	Sun Pharm Industries	22	Marketed
Jun 5, 1990	Imipramine HydrochlorideANDA 81050	Sun Pharm Industries	21	Marketed
Sep 16, 1994	Imipramine HydrochlorideANDA 84869	Sandoz	9	Discontinued
Feb 28, 2008	Imipramine HydrochlorideANDA 40751	Oxford Pharms	3	Marketed
Mar 11, 2010	Imipramine HydrochlorideANDA 90441	Chartwell	3	Discontinued
Oct 24, 2012	Imipramine HydrochlorideANDA 40903	Leading	3	Marketed
—	Imipramine HydrochlorideANDA 85221	Watson Labs	0	Discontinued
—	Imipramine HydrochlorideANDA 84252	Watson Labs	0	Discontinued
—	Imipramine HydrochlorideANDA 85220	Watson Labs	0	Discontinued
—	Imipramine HydrochlorideANDA 86267	Lederle	1	Discontinued
—	Imipramine HydrochlorideANDA 86268	Lederle	1	Discontinued
—	Imipramine HydrochlorideANDA 86269	Lederle	1	Discontinued
—	Imipramine HydrochlorideANDA 86765	Novartis	0	Discontinued
—	Imipramine HydrochlorideANDA 88223	West Ward	0	Discontinued
—	Imipramine HydrochlorideANDA 88222	West Ward	0	Discontinued

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA