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Drug Name
|
Active Ingredient
|
Dosage Form/Route
|
Sponsor
|
Submission Type
|
acetylcysteine
|
Injectable; Intravenous
|
Cumberland Pharms
|
Manufacturing Change or Addition
|
|
pegademase bovine
|
Injectable; Injection
|
Sigma Tau
|
Manufacturing Change or Addition
|
|
formoterol fumarate; mometasone
furoate
|
Aerosol, Metered; Inhalation
|
Merck Sharp Dohme
|
Labeling Revision
|
|
estradiol
|
Spray; Transdermal
|
Kv Pharm
|
Manufacturing Change or Addition
|
|
choriogonadotropin alfa
|
Injectable; Injection
|
Emd Serono
|
Manufacturing Change or Addition
|
|
choriogonadotropin alfa
|
Injectable; Subcutaneous
|
Emd Serono
|
Manufacturing Change or Addition
|
|
fenofibrate
|
Tablet; Oral
|
Skyepharma Ag
|
Labeling Revision
|
January 14, 2013
Drug Name
|
Active Ingredient
|
Dosage Form/Route
|
Sponsor
|
Submission Type
|
aspirin
|
Capsule; Oral
|
Plx Pharma Inc
|
Approval
|
|
arformoterol tartrate
|
Solution; Inhalation
|
Sunovion
|
Manufacturing Change or Addition
|
|
betamethasone dipropionate;
calcipotriene hydrate
|
Ointment; Topical
|
Tolmar
|
Approval
|
|
morphine sulfate
|
Capsule, Extended Release; Oral
|
Actavis Elizabeth
|
Manufacturing Change or Addition
|
|
oxymorphone hydrochloride
|
Tablet, Extended Release; Oral
|
Endo Pharms
|
Labeling Revision
|
|
chlorhexidine gluconate
|
Solution; Dental
|
3m
|
Manufacturing Change or Addition
|
|
budesonide
|
Tablet; Oral
|
Santarus
|
Approval
|
January 11, 2013
Drug Name
|
Active Ingredient
|
Dosage Form/Route
|
Sponsor
|
Submission Type
|
dicyclomine hydrochloride
|
Capsule; Oral
|
Aptalis Pharma Us
|
Labeling Revision
|
|
dicyclomine hydrochloride
|
Tablet; Oral
|
Aptalis Pharma Us
|
Labeling Revision
|
|
dicyclomine hydrochloride
|
Injectable; Injection
|
Aptalis Pharma Us
|
Labeling Revision
|
|
dicyclomine hydrochloride
|
Injectable; Injection
|
Aptalis Pharma Us
|
Labeling Revision
|
|
clonidine hydrochloride
|
Injectable; Injection
|
Mylan Institutional
|
Manufacturing Change or Addition
|
|
follitropin alfa/beta
|
Injectable; Subcutaneous
|
Emd Serono
|
Manufacturing Change or Addition
|
|
desmopressin acetate
|
Spray, Metered; Nasal
|
Ferring
|
Manufacturing Change or Addition
|
|
oxycodone hydrochloride
|
Tablet, Extended Release; Oral
|
Purdue Pharma Lp
|
Labeling Revision
|
|
oxycodone hydrochloride
|
Tablet, Extended Release; Oral
|
Purdue Pharma Lp
|
Labeling Revision
|
|
somatropin recombinant
|
Injectable; Injection
|
Emd Serono
|
Manufacturing Change or Addition
|
|
ezetimibe
|
Tablet; Oral
|
Msd Intl Gmbh
|
Manufacturing Change or Addition
|
January 10, 2013
Drug Name
|
Active Ingredient
|
Dosage Form/Route
|
Sponsor
|
Submission Type
|
verapamil hydrochloride
|
Tablet, Extended Release; Oral
|
Pfizer
|
Manufacturing Change or Addition
|
|
clofarabine
|
Injectable; Iv (Infusion)
|
Genzyme
|
Labeling Revision
|
|
fenofibrate
|
Capsule; Oral
|
Mylan Pharms Inc
|
Approval
|
|
heparin sodium
|
Injectable; Injection
|
B Braun
|
Labeling Revision
|
|
ambrisentan
|
Tablet; Oral
|
Gilead
|
Manufacturing Change or Addition
|
|
baclofen
|
Injectable; Intrathecal
|
Medtronic
|
Manufacturing Change or Addition
|
|
nicardipine hydrochloride
|
Injectable; Injection
|
Exela Pharma Science
|
Manufacturing Change or Addition
|
|
vilazodone hydrochloride
|
Tablet; Oral
|
Forest Labs Inc
|
Manufacturing Change or Addition
|
January 9, 2013
Drug Name
|
Active Ingredient
|
Dosage Form/Route
|
Sponsor
|
Submission Type
|
oxybutynin
|
Gel, Metered; Transdermal
|
Watson Labs Inc
|
Labeling Revision
|
|
bromfenac sodium
|
Solution/Drops; Ophthalmic
|
Pharmaforce
|
Approval
|
|
betamethasone acetate; betamethasone
sodium phosphate
|
Injectable; Injection
|
Schering
|
Manufacturing Change or Addition
|
|
albuterol sulfate; ipratropium bromide
|
Spray, Metered; Inhalation
|
Boehringer Ingelheim
|
Manufacturing Change or Addition
|
|
amino acids
|
Injectable; Injection
|
B Braun
|
Manufacturing Change or Addition
|
|
amino acids
|
Injectable; Injection
|
B Braun
|
Manufacturing Change or Addition
|
|
amino acids
|
Injectable; Injection
|
B Braun
|
Manufacturing Change or Addition
|
|
amino acids
|
Injectable; Injection
|
B Braun
|
Manufacturing Change or Addition
|
|
amino acids; magnesium acetate;
phosphoric acid; potassium chloride; sodium acetate; sodium chloride
|
Injectable; Injection
|
B Braun
|
Manufacturing Change or Addition
|
|
amino acids
|
Injectable; Injection
|
B Braun
|
Manufacturing Change or Addition
|
|
amino acids; magnesium acetate;
phosphoric acid; potassium acetate; potassium chloride; sodium acetate
|
Injectable; Injection
|
B Braun
|
Manufacturing Change or Addition
|
|
heparin sodium
|
Injectable; Injection
|
B Braun
|
Labeling Revision
|
|
heparin sodium
|
Injectable; Injection
|
B Braun
|
Labeling Revision
|
|
insulin recombinant human
|
Injectable; Injection
|
Lilly
|
Manufacturing Change or Addition
|
|
insulin recombinant human
|
Injectable; Injection
|
Lilly
|
Manufacturing Change or Addition
|
|
paclitaxel
|
Injectable; Injection
|
Hospira
|
Labeling Revision
|
|
albuterol sulfate
|
Aerosol, Metered; Inhalation
|
Teva Global
|
Manufacturing Change or Addition
|
|
levonorgestrel
|
System; Intrauterine
|
Bayer Healthcare Pharms
|
Approval
|
|
levalbuterol hydrochloride
|
Solution; Inhalation
|
Sunovion
|
Manufacturing Change or Addition
|
|
levalbuterol tartrate
|
Aerosol, Metered; Inhalation
|
Sunovion
|
Manufacturing Change or Addition
|
January 8, 2013
Drug Name
|
Active Ingredient
|
Dosage Form/Route
|
Sponsor
|
Submission Type
|
caspofungin acetate
|
Injectable; Iv (Infusion)
|
Merck
|
Labeling Revision
|
|
gabapentin
|
Tablet; Oral
|
Allied Pharma Inc
|
Tentative Approval
|
|
tretinoin
|
Cream; Topical
|
Valeant Intl
|
Manufacturing Change or Addition
|
|
tretinoin
|
Cream; Topical
|
Valeant Intl
|
Manufacturing Change or Addition
|
|
tretinoin
|
Cream; Topical
|
Valeant Intl
|
Manufacturing Change or Addition
|
|
tretinoin
|
Cream; Topical
|
Valeant Intl
|
Manufacturing Change or Addition
|
|
tretinoin
|
Cream; Topical
|
Valeant Intl
|
Manufacturing Change or Addition
|
|
tretinoin
|
Gel; Topical
|
Valeant Intl
|
Manufacturing Change or Addition
|
|
temozolomide
|
Capsule; Oral
|
Merck Sharp Dohme
|
Manufacturing Change or Addition
|
January 7, 2013
Drug Name
|
Active Ingredient
|
Dosage Form/Route
|
Sponsor
|
Submission Type
|
naproxen sodium
|
Tablet; Oral
|
Bayer
|
Manufacturing Change or Addition
|
|
chlorhexidine gluconate
|
Sponge; Topical
|
Griffen
|
Labeling Revision
|
|
ceftriaxone sodium
|
Injectable; Injection
|
Strides Arcolab Ltd
|
Approval
|
|
tesamorelin acetate
|
Powder; Subcutaneous
|
Emd Serono
|
Manufacturing Change or Addition
|
|
amlodipine besylate
|
Tablet; Oral
|
Pfizer
|
Labeling Revision
|
|
sildenafil citrate
|
Tablet; Oral
|
Teva Pharms
|
Approval
|
|
treprostinil sodium
|
Solution; Inhalation
|
United Therap
|
Manufacturing Change or Addition
|
January 3, 2013
Drug
Name
|
Active
Ingredient
|
Dosage
Form/Route
|
Sponsor
|
Submission
Type
|
naproxen
sodium
|
Tablet;
Oral
|
Bayer
|
Manufacturing
Change or Addition
|
|
ondansetron
hydrochloride
|
Injectable;
Injection
|
Emcure
Pharms Ltd
|
Approval
|
|
fluoxetine
hydrochloride
|
Capsule;
Oral
|
Eli
Lilly and Co
|
Labeling
Revision
|
|
fluoxetine
hydrochloride
|
Capsule,
Delayed Rel Pellets; Oral
|
Lilly
|
Labeling
Revision
|
|
fluoxetine
hydrochloride
|
Capsule;
Oral
|
Eli
Lilly and Co
|
Labeling
Revision
|
|
fluoxetine
hydrochloride; olanzapine
|
Capsule;
Oral
|
Lilly
|
Labeling
Revision
|
December 31, 2012
Drug
Name
|
Active
Ingredient
|
Dosage
Form/Route
|
Sponsor
|
Submission
Type
|
disulfiram
|
Tablet;
Oral
|
Vintage
Pharms
|
Approval
|
|
crofelemer
|
Tablet,
Delayed Release; Oral
|
Salix
Pharms
|
Approval
|
|
pregabalin
|
Capsule;
Oral
|
Sandoz
Inc
|
Tentative
Approval
|
|
rizatriptan
benzoate
|
Tablet;
Oral
|
Teva
Pharms
|
Approval
|
|
rizatriptan
benzoate
|
Tablet,
Orally Disintegrating; Oral
|
Mylan
Pharma
|
Approval
|
|
rizatriptan
benzoate
|
Tablet;
Oral
|
Sandoz
|
Approval
|
|
rizatriptan
benzoate
|
Tablet;
Oral
|
Natco
Pharma Ltd
|
Approval
|
|
rizatriptan
benzoate
|
Tablet;
Oral
|
Glenmark
Generics
|
Approval
|
|
rizatriptan
benzoate
|
Tablet;
Oral
|
Mylan
Pharms Inc
|
Approval
|
|
rizatriptan
benzoate
|
Tablet;
Oral
|
Sun
Pharma Global
|
Approval
|
|
rizatriptan
benzoate
|
Tablet;
Oral
|
Apotex
Corp
|
Approval
|
|
rizatriptan
benzoate
|
Tablet;
Oral
|
Aurobindo
Pharma Ltd
|
Approval
|
December 28, 2012
Drug
Name
|
Active
Ingredient
|
Dosage
Form/Route
|
Sponsor
|
Submission
Type
|
apixaban
|
Tablet;
Oral
|
Bristol
Myers Squibb
|
Approval
|
|
bedaquiline
|
Tablet;
Oral
|
Janssen
R and D
|
Approval
|
December 27, 2012
Drug
Name
|
Active
Ingredient
|
Dosage
Form/Route
|
Sponsor
|
Submission
Type
|
tranexamic
acid
|
Tablet;
Oral
|
Watson
Labs Inc Fl
|
Approval
|
December 26, 2012
Drug
Name
|
Active
Ingredient
|
Dosage
Form/Route
|
Sponsor
|
Submission
Type
|
gabapentin
enacarbil
|
Tablet,
Extended Release; Oral
|
Glaxo
Grp Ltd
|
Labeling
Revision
|
|
peginterferon
alfa-2b
|
Syringe
|
Schering
|
Labeling
Revision
|
|
peginterferon
alfa-2b
|
Vial
|
Schering
|
Labeling
Revision
|
|
peginterferon
alfa-2b
|
Vial
|
Schering
|
Labeling
Revision
|
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