Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 050276
Company: LEDERLE

Products on NDA 050276

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ACHROMYCIN	PROCAINE HYDROCHLORIDE; TETRACYCLINE HYDROCHLORIDE	40MG/VIAL;100MG/VIAL	INJECTABLE;INJECTION	Discontinued	None	No	No
ACHROMYCIN	PROCAINE HYDROCHLORIDE; TETRACYCLINE HYDROCHLORIDE	40MG/VIAL;250MG/VIAL	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 050276

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/01/1954	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
10/09/1986	SUPPL-45	Labeling		Label is not available on this site.
09/30/1985	SUPPL-44	Manufacturing (CMC)-Control		Label is not available on this site.
08/28/1984	SUPPL-43	Manufacturing (CMC)		Label is not available on this site.
07/24/1984	SUPPL-42	Manufacturing (CMC)-Control		Label is not available on this site.
03/22/1982	SUPPL-40	Labeling		Label is not available on this site.
05/12/1981	SUPPL-39	Manufacturing (CMC)-Control		Label is not available on this site.
03/20/1981	SUPPL-38	Manufacturing (CMC)-Control		Label is not available on this site.
09/18/1979	SUPPL-37	Manufacturing (CMC)-Control		Label is not available on this site.
06/07/1978	SUPPL-36	Labeling		Label is not available on this site.
01/13/1975	SUPPL-35	Manufacturing (CMC)-Control		Label is not available on this site.
04/26/1974	SUPPL-34	Manufacturing (CMC)-Control		Label is not available on this site.
06/21/1973	SUPPL-33	Labeling		Label is not available on this site.
10/21/1973	SUPPL-32	Manufacturing (CMC)-Formulation		Label is not available on this site.
01/05/1971	SUPPL-31	Labeling		Label is not available on this site.
06/21/1973	SUPPL-30	Labeling		Label is not available on this site.
01/05/1966	SUPPL-28	Labeling		Label is not available on this site.
08/12/1964	SUPPL-27	Labeling		Label is not available on this site.
10/24/1963	SUPPL-26	Manufacturing (CMC)-Packaging		Label is not available on this site.
05/27/1963	SUPPL-25	Labeling		Label is not available on this site.
10/30/1961	SUPPL-22	Labeling		Label is not available on this site.
04/07/1961	SUPPL-21	Labeling		Label is not available on this site.
03/13/1961	SUPPL-20	Manufacturing (CMC)-Control		Label is not available on this site.
03/17/1960	SUPPL-19	Labeling		Label is not available on this site.
07/31/1959	SUPPL-18	Manufacturing (CMC)-Control		Label is not available on this site.
02/06/1959	SUPPL-17	Manufacturing (CMC)-Control		Label is not available on this site.
01/14/1960	SUPPL-16	Manufacturing (CMC)-Packaging		Label is not available on this site.
08/18/1958	SUPPL-15	Labeling		Label is not available on this site.
08/18/1958	SUPPL-14	Labeling		Label is not available on this site.
07/18/1955	SUPPL-13	Manufacturing (CMC)-Control		Label is not available on this site.
11/20/1991	SUPPL-10	Labeling		Label is not available on this site.
11/20/1991	SUPPL-8	Labeling		Label is not available on this site.
11/20/1991	SUPPL-7	Labeling		Label is not available on this site.
04/19/1957	SUPPL-6	Labeling		Label is not available on this site.
03/04/1955	SUPPL-5	Manufacturing (CMC)-Control		Label is not available on this site.
11/29/1954	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
09/24/1954	SUPPL-2	Labeling		Label is not available on this site.