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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 012770
Company: SAPTALIS PHARMS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VOSOL HC ACETIC ACID, GLACIAL; HYDROCORTISONE 2%;1% SOLUTION/DROPS;OTIC Prescription AT Yes Yes

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/23/1961 ORIG-1 Approval Type 4 - New Combination 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
12/03/2024 SUPPL-33 Labeling-Package Insert, Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/012770Orig1s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/012770Orig1s033ltr.pdf
10/16/1997 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.
07/29/1997 SUPPL-24 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/1997/012770s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1997/012770s024ltr.pdf
12/21/1995 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.
08/01/1990 SUPPL-21 Labeling

Label is not available on this site.
08/01/1990 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.
09/15/1988 SUPPL-19 Manufacturing (CMC)-Packaging

Label is not available on this site.
09/15/1988 SUPPL-18 Manufacturing (CMC)-Formulation

Label is not available on this site.
06/29/1988 SUPPL-16 Labeling

Label is not available on this site.
08/26/1986 SUPPL-15 Manufacturing (CMC)-Packaging

Label is not available on this site.
06/24/1985 SUPPL-14 Manufacturing (CMC)-Packaging

Label is not available on this site.
04/05/1984 SUPPL-13 Manufacturing (CMC)-Packaging

Label is not available on this site.
02/04/1983 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.
08/14/1984 SUPPL-10 Labeling

Label is not available on this site.
07/25/1978 SUPPL-9 Labeling

Label is not available on this site.
12/04/1978 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.
04/07/1976 SUPPL-6 Manufacturing (CMC)-Packaging

Label is not available on this site.
06/02/1975 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.
07/16/1974 SUPPL-4

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
12/03/2024 SUPPL-33 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/012770Orig1s033lbl.pdf
12/03/2024 SUPPL-33 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/012770Orig1s033lbl.pdf
07/29/1997 SUPPL-24 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/1997/012770s024lbl.pdf

VOSOL HC

SOLUTION/DROPS;OTIC; 2%;1%
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
HYDROCORTISONE AND ACETIC ACID ACETIC ACID, GLACIAL; HYDROCORTISONE 2%;1% SOLUTION/DROPS;OTIC Prescription No AT 040609 COSETTE
HYDROCORTISONE AND ACETIC ACID ACETIC ACID, GLACIAL; HYDROCORTISONE 2%;1% SOLUTION/DROPS;OTIC Prescription Yes AT 088759 TARO
VOSOL HC ACETIC ACID, GLACIAL; HYDROCORTISONE 2%;1% SOLUTION/DROPS;OTIC Prescription Yes AT 012770 SAPTALIS PHARMS
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