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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050612
Company: ALLERGAN

Products on NDA 050612

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PRED-G	GENTAMICIN SULFATE; PREDNISOLONE ACETATE	EQ 0.3% BASE;0.6%	OINTMENT;OPHTHALMIC	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 050612

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/01/1989	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/07/2018	SUPPL-21	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050612s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/050612Orig1s021ltr.pdf
03/20/2017	SUPPL-20	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050612s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050612Orig1s020ltr.pdf
10/22/2003	SUPPL-14	Manufacturing (CMC)	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50612SCM014ltr.pdf
01/28/2002	SUPPL-13	Manufacturing (CMC)-Control		Label is not available on this site.
04/12/2001	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
10/02/2000	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
11/09/1999	SUPPL-10	Manufacturing (CMC)-Packaging		Label is not available on this site.
07/16/1999	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
04/26/1999	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
12/29/1997	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
06/04/1997	SUPPL-6	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for NDA 050612

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/07/2018	SUPPL-21	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050612s021lbl.pdf
03/20/2017	SUPPL-20	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050612s020lbl.pdf

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