Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050143
Company: PARKEDALE

Products on NDA 050143

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 050143

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/01/1951	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
08/14/1996	SUPPL-16	Labeling		Label is not available on this site.
09/28/1982	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
04/08/1981	SUPPL-14	Manufacturing (CMC)-Control		Label is not available on this site.
01/08/1981	SUPPL-13	Labeling		Label is not available on this site.
11/08/1979	SUPPL-12	Labeling		Label is not available on this site.
08/03/1978	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
06/29/1978	SUPPL-10	Labeling		Label is not available on this site.
02/23/1977	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
02/24/1958	SUPPL-8	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
08/30/1956	SUPPL-6	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
12/01/1988	SUPPL-5	Manufacturing (CMC)-Control		Label is not available on this site.
09/29/1986	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
09/23/1983	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.