Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 014764
Company: ROBINS AH

Products on NDA 014764

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ROBINUL	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 014764

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/28/1980	SUPPL-23	Manufacturing (CMC)		Label is not available on this site.
03/28/1980	SUPPL-22	Manufacturing (CMC)-Formulation		Label is not available on this site.
04/02/1980	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.
08/07/1978	SUPPL-19	Labeling		Label is not available on this site.
07/17/1978	SUPPL-18	Labeling		Label is not available on this site.
05/31/1978	SUPPL-16	Manufacturing (CMC)-Packaging		Label is not available on this site.
12/12/1977	SUPPL-15	Manufacturing (CMC)-Control		Label is not available on this site.
09/07/1977	SUPPL-14	Manufacturing (CMC)-Control		Label is not available on this site.
03/19/1976	SUPPL-10	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
02/09/1976	SUPPL-9	Manufacturing (CMC)-Control		Label is not available on this site.
12/17/1975	SUPPL-8	Labeling		Label is not available on this site.
04/02/1980	SUPPL-7	Manufacturing (CMC)-Packaging		Label is not available on this site.