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Drugs@FDA: FDA-Approved Drugs

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

Products on NDA 012770

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 012770

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
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.

Labels for NDA 012770

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

Therapeutic Equivalents for NDA 012770

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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