Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050202
Company: PARKEDALE

Products on NDA 050202

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CHLOROMYCETIN HYDROCORTISONE	CHLORAMPHENICOL; HYDROCORTISONE ACETATE	12.5MG/VIAL;25MG/VIAL	FOR SUSPENSION;OPHTHALMIC	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 050202

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/09/1953	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
09/28/1982	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
07/07/1982	SUPPL-16	Labeling		Label is not available on this site.
12/02/1980	SUPPL-15	Labeling		Label is not available on this site.
05/29/1980	SUPPL-14	Labeling		Label is not available on this site.
08/03/1978	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
02/23/1977	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
08/16/1956	SUPPL-10	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
06/12/1956	SUPPL-9	Manufacturing (CMC)-Formulation		Label is not available on this site.
09/25/1992	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
04/06/1992	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
09/29/1986	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
09/17/1984	SUPPL-4	Manufacturing (CMC)-Packaging		Label is not available on this site.
04/08/1954	SUPPL-3	Manufacturing (CMC)-Formulation		Label is not available on this site.
05/11/1954	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.
11/08/1983	SUPPL-1	Labeling		Label is not available on this site.