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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 011963
Company: FERA PHARMS LLC

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PHOSPHOLINE IODIDE ECHOTHIOPHATE IODIDE 0.125% FOR SOLUTION;OPHTHALMIC Prescription None Yes Yes
PHOSPHOLINE IODIDE ECHOTHIOPHATE IODIDE 0.03% FOR SOLUTION;OPHTHALMIC Discontinued None No No
PHOSPHOLINE IODIDE ECHOTHIOPHATE IODIDE 0.25% FOR SOLUTION;OPHTHALMIC Discontinued None No No
PHOSPHOLINE IODIDE ECHOTHIOPHATE IODIDE 0.06% FOR SOLUTION;OPHTHALMIC Discontinued None No No

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/27/1960 ORIG-1 Approval Type 1 - New Molecular Entity 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
10/28/2021 SUPPL-52 Labeling-Container/Carton Labels, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/011963s052lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/011963Orig1s052ltr.pdf
07/03/2018 SUPPL-48 Labeling-Package Insert Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/011963Orig1s048ltr.pdf
02/28/2014 SUPPL-47 Manufacturing (CMC)

Label is not available on this site.
03/09/2006 SUPPL-34 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/011963s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/011963s034ltr.pdf
04/12/2002 SUPPL-32 Manufacturing (CMC)-Expiration Date

Label is not available on this site.
03/10/1998 SUPPL-31 Manufacturing (CMC)-Control

Label is not available on this site.
03/21/1995 SUPPL-30 Manufacturing (CMC)-Expiration Date

Label is not available on this site.
05/17/1993 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.
07/13/1990 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.
01/09/1990 SUPPL-27 Manufacturing (CMC)-Packaging

Label is not available on this site.
08/01/1989 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.
11/29/1988 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.
10/30/1984 SUPPL-24 Manufacturing (CMC)-Formulation

Label is not available on this site.
05/11/1987 SUPPL-23 Labeling

Label is not available on this site.
05/26/1982 SUPPL-22 Manufacturing (CMC)-Formulation

Label is not available on this site.
06/10/1982 SUPPL-21 Manufacturing (CMC)-Packaging

Label is not available on this site.
12/28/1981 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.
11/25/1981 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.
05/19/1981 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.
08/01/1979 SUPPL-17 Labeling

Label is not available on this site.
01/02/1980 SUPPL-16 Manufacturing (CMC)-Formulation

Label is not available on this site.
08/09/1978 SUPPL-15 Labeling

Label is not available on this site.
08/09/1978 SUPPL-14 Manufacturing (CMC)-Packaging

Label is not available on this site.
08/09/1978 SUPPL-13 Manufacturing (CMC)-Packaging

Label is not available on this site.
10/13/1976 SUPPL-12

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
10/28/2021 SUPPL-52 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/011963s052lbl.pdf
10/28/2021 SUPPL-52 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/011963s052lbl.pdf
03/09/2006 SUPPL-34 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/011963s034lbl.pdf
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