An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 012179
Company: HIKMA

Products on NDA 012179

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VOSOL	ACETIC ACID, GLACIAL	2%	SOLUTION/DROPS;OTIC	Prescription	AT	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 012179

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/17/1960	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-19	Manufacturing (CMC)		Label is not available on this site.
07/29/1997	SUPPL-18	Labeling		Label is not available on this site.
12/21/1995	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
06/29/1988	SUPPL-15	Labeling		Label is not available on this site.
08/26/1986	SUPPL-14	Manufacturing (CMC)-Packaging		Label is not available on this site.
06/24/1985	SUPPL-13	Manufacturing (CMC)-Packaging		Label is not available on this site.
08/03/1987	SUPPL-12	Labeling		Label is not available on this site.
06/06/1984	SUPPL-11	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
06/06/1984	SUPPL-8	Labeling		Label is not available on this site.
06/02/1975	SUPPL-6	Manufacturing (CMC)-Control		Label is not available on this site.
07/16/1974	SUPPL-5			Label is not available on this site.

Therapeutic Equivalents for NDA 012179

VOSOL

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

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ACETIC ACID	ACETIC ACID, GLACIAL	2%	SOLUTION/DROPS;OTIC	Prescription	No	AT	207280	RISING
ACETIC ACID	ACETIC ACID, GLACIAL	2%	SOLUTION/DROPS;OTIC	Prescription	No	AT	040607	SAPTALIS PHARMS
ACETIC ACID	ACETIC ACID, GLACIAL	2%	SOLUTION/DROPS;OTIC	Prescription	No	AT	088638	TARO
VOSOL	ACETIC ACID, GLACIAL	2%	SOLUTION/DROPS;OTIC	Prescription	No	AT	012179	HIKMA

Top