Friday, February 25, 2011

USFDA update

USFDA has updated Paragraph IV certification list as of 21 February 2011. Table shows the newly added molecule.

DRUG NAME
DOSAGE FORM
STRENGTH
RLD
DATE OF SUBMISSION
Clarithromycin
Extended-release Tablet
500 mg
Biaxin XL
12/6/2010
Dexlansoprazole
Delayed-release Capsule
30 mg
Dexilant
11/30/2010
Dexmethylphenidate Hydrochloride
Extended-release Capsule
30 mg
Focalin XR
12/15/2010
Diclofenac
Potassium Oral Solution (Sachet)
50 mg
Cambia
1/24/2011
Gatifloxacin
Ophthalmic Solution
0.5%
Zymaxid
12/7/2010
Oxycodone Hydrochloride
Extended-release Tablet
10 mg
OxyContin
(NDA 022272)
10/25/2010
Oxycodone Hydrochloride
Extended-release Tablet
15 mg
OxyContin
 (NDA 022272)
10/28/2010
Oxycodone Hydrochloride
Extended-release Tablet
20 mg
OxyContin
(NDA 022272)
10/29/2010
Oxycodone Hydrochloride
Extended-release Tablet
30 mg, 60 mg and 80 mg
OxyContin
(NDA 022272)
10/18/2010
Oxycodone Hydrochloride
Extended-release Tablet
40 mg
OxyContin
(NDA 022272)
10/4/2010
Tretinoin
Gel
0.1%
Retin-A Micro
7/8/2010

No comments:

Post a Comment