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May Abbreviated Approvals

This article was originally published in Pharmaceutical Approvals Monthly

Product

Sponsor

Date Approved

(Application No.)

Bromfenac sodium, 0.09% ophthalmic solution/drops

Coastal

5/11/2011

(201-211)

Budesonide, 3 mg caps.

Mylan

5/16/2011

(90-410)

Carbamazepine, 100 mg, 200 mg and 300 mg extended-release caps.

Nostrum

5/20/2011

(76-697)

Carbinoxamine maleate, 4 mg tabs.

Rivers Edge

5/27/2011

(90-756)

Clindamycin HCl, EQ 75 mg base, EQ 150 mg base and EQ 300 mg base caps.

Matrix

5/31/2011

(91-225)

Dexamethasone, 0.5 mg/5 mL oral elixir

Vintage

5/11/2011

(91-188)

Donepezil HCl, 5 mg and 10 mg orally disintegrating tabs.

Zydus

5/10/2011

(90-175)

Donepezil HCl, 5 mg and 10 mg orally disintegrating tabs.

Sandoz

5/10/2011

(91-198)

Donepezil HCl, 5 mg and 10 mg tabs.

Teva

5/31/2011

(77-344)

Donepezil HCl, 5 mg and 10 mg tabs.

Cipla

5/31/2011

(77-518)

Donepezil HCl, 5 mg and 10 mg tabs.

Roxane

5/31/2011

(78-662)

Donepezil HCl, 5 mg and 10 mg tabs.

Aurobindo

5/31/2011

(90-056)

Donepezil HCl, 5 mg and 10 mg tabs.

Hikma

5/31/2011

(90-247)

Donepezil HCl, 5 mg and 10 mg tabs.

Sandoz

5/31/2011

(90-290)

Donepezil HCl, 5 mg and 10 mg tabs.

Pliva

5/31/2011

(90-425)

Donepezil HCl, 5 mg and 10 mg tabs.

Sun

5/31/2011

(90-493)

Donepezil HCl, 5 mg and 10 mg tabs.

Matrix

5/31/2011

(90-521)

Donepezil HCl, 5 mg and 10 mg tabs.

Actavis

5/31/2011

(90-551)

Donepezil HCl, 5 mg and 10 mg tabs.

Torrent

5/31/2011

(90-686)

Donepezil HCl, 5 mg and 10 mg tabs.

Jubilant

5/31/2011

(90-768)

Donepezil HCl, 5 mg and 10 mg tabs.

Wockhardt

5/31/2011

(91-267)

Donepezil HCl, 5 mg and 10 mg tabs.

Huahai

5/31/2011

(200-292)

Donepezil HCl, 5 mg and 10 mg tabs.

Dr. Reddy’s

5/31/2011

(201-001)

Eszopiclone, 1 mg, 2 mg and 3 mg tabs.

Teva

5/23/2011

(91-169)

Ethinyl estradiol/levonorgestrel, 0.02 mg/0.1 mg oral-28 tabs.

Vintage

5/11/2011

(77-099)

Fluorouracil, 2.5 gm/50 mL (50 mg/mL) and 5 gm/100 ml (50 mg/mL) inj.

Sandoz

5/2/2011

(91-299)

Fluticasone propionate, 0.05% topical lotion

Glenmark

5/2/2011

(90-759)

Gemcitabine HCl, EQ 2 gm base/vial inj.

Fresenius Kabi

5/16/2011

(90-799)

Gemcitabine HCl, EQ 2 gm base/vial inj.

APP

5/17/2011

(90-242)

Irinotecan HCl, 20 mg/mL, 40 mg/2 mL (20 mg/mL) and 100 mg/5 mL (20 mg/mL) inj.

Bioniche

5/13/2011

(90-393)

Lamivudine/zidovudine, 150 mg/300 mg tabs.

Teva

5/25/2011

(79-081)

Levonorgestrel/ethinyl estradiol/ethinyl estradiol, 0.15 mg/0.03 mg/0.01 mg tabs.

Watson

5/31/2011

(78-834)

Meprobamate, 200 mg and 400 mg tabs.

Taro

5/23/2011

(200-998)

Methylergonovine maleate, 0.2 mg tabs.

Novel

5/2/2011

(91-577)

Midazolam HCl, EQ 1 mg base/mL and EQ 5 mg base/mL inj.

Sagent Strides

5/4/2011

(90-316)

Nitrofurantoin, 25 mg/5 mL oral suspension

Amneal

5/11/2011

(201-679)

Octreotide acetate, EQ 0.05 mg base/mL, EQ 0.1 mg base/mL and EQ 0.5 mg base/mL inj.

Wockhardt

5/11/2011

(90-985)

Octreotide acetate, EQ 0.2 mg base/mL and EQ 1 mg base/mL inj.

Wockhardt

5/11/2011

(90-986)

Piperacillin/tazobactam, 2.25 g, 3.375 g and 4.5 g inj.

Instituto Biochimico

5/31/2011

(65-523)

Piperacillin/tazobactam, 40.5 g inj.

Instituto Biochimico

5/31/2011

(90-498)

Piperacillin/tazobactam, EQ 2 gm base/vial/EQ 250 mg base/vial; EQ 3 gm base/vial/EQ 375 mg base/vial and EQ 4 gm base/vial/EQ 500 mg base/vial inj.

Aurobindo

5/23/2011

(65-498)

Risperidone, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg tabs.

Cipla

5/18/2011

(77-543)

Risperidone, 1 mg/mL oral solution

Amneal

5/25/2011

(91-384)

Sodium polystyrene sulfonate, 15 gm/60 mL oral rectal suspension

Paddock

5/13/2011

(90-590)

Venlafaxine HCl, EQ 37.5 mg base, EQ 75 mg base and EQ 150 mg base extended-release caps.

Dr. Reddy’s

5/6/2011

(78-421)

Warfarin sodium, 1 mg, 2 mg, 2.5 mg, 3 mg, 4 mg, 5 mg, 6 mg, 7.5 mg and 10 mg tabs.

Invagen

5/25/2011

(90-935)

Tentative Abbreviated

Abacavir sulfate/lamivudine, 60 mg/30 mg suspension/tab.

Cipla

5/12/2011

(202-007)

Brimonidine tartrate/timolol maleate, 0.2%/0.5% ophthalmic solution

Sandoz

5/11/2011

(91-087)

Desloratadine, 5 mg tabs.

Zydus

5/23/2011

(78-353)

Fluocinonide, 0.1% topical cream

Taro

5/31/2011

(200-734)

Gemcitabine, 200 mg and 1 g inj.

Fresenius Kabi

5/16/2011

(90-799)

Gemcitabine, 200 mg and 1 g inj.

APP

5/17/2011

(90-242)

Levetiracetam, 500 mg and 750 mg extended-release tabs.

Lupin

5/5/2011

(91-399)

Levocetirizine dihydrochloride, 0.5 mg/mL oral solution

Synthon

5/13/2011

(91-263)

Tenofovir disoproxil fumarate, 300 mg tabs.

Strides Arcolab

5/25/2011

(90-742)

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