Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078185
Company: HIKMA

Products on ANDA 078185

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
GALANTAMINE HYDROBROMIDE	GALANTAMINE HYDROBROMIDE	4MG/ML	SOLUTION;ORAL	Prescription	None	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 078185

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/30/2009	ORIG-1	Approval			Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/078185s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/078185s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/02/2023	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
07/17/2018	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
07/17/2018	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
11/17/2015	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
11/17/2015	SUPPL-2	Labeling-Package Insert		Label is not available on this site.
11/17/2015	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Labels for ANDA 078185

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/30/2009	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/078185s000lbl.pdf