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  #1  
Old 10-26-11, 09:40 PM
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Mikart Pharmaceuticals generic dexedrine tablets available in 7 strengths

Approval date of 10/25/2011 Dextroamphetamine Sulfate tablets available in 2.5mg/5mg/7.5mg/10mg/15mg/20mg/30mg

http://www.accessdata.fda.gov/script...3&TABLE1=OB_Rx

http://www.accessdata.fda.gov/script...ocs/tempai.cfm

*on second link type in dextroamphetamine in active ingredient search box
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  #2  
Old 10-26-11, 09:48 PM
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Re: Mikart Pharmaceuticals generic dexedrine tablets available in 7 strengths

Interesting... a 30 mg Dexedrine tablet is in the works? This is good news for some.
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Old 10-26-11, 10:06 PM
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Re: Mikart Pharmaceuticals generic dexedrine tablets available in 7 strengths

I'd have to divide that one in 6 equal parts :/
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Old 10-26-11, 10:33 PM
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Re: Mikart Pharmaceuticals generic dexedrine tablets available in 7 strengths

I wonder how fast they'll be making them ....and will they be better than Barr/Teva ? wouldn't that be wonderful ......
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Old 10-26-11, 10:51 PM
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Re: Mikart Pharmaceuticals generic dexedrine tablets available in 7 strengths

Dexedrine comes in the same mgs as Adderall? I thought it was available in only 5mg and 10 mg (and at one time 15 mg).
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Old 10-26-11, 10:52 PM
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Re: Mikart Pharmaceuticals generic dexedrine tablets available in 7 strengths

In Australia it's only 5mg.
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Old 10-26-11, 11:11 PM
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Re: Mikart Pharmaceuticals generic dexedrine tablets available in 7 strengths

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Originally Posted by BR549 View Post
Dexedrine comes in the same mgs as Adderall? I thought it was available in only 5mg and 10 mg (and at one time 15 mg).
I believe that there was a citizen's petition and/or ANDA to allow for this (with the theory being that it would allow for dosing flexibility and to improve compliance because the tabs are all scored and the label allows for dosages of up to 60mg/day in divided doses for Narcolepsy).

This is, indeed, an excellent development--if the product actually appears on the market.
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Old 10-26-11, 11:19 PM
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Re: Mikart Pharmaceuticals generic dexedrine tablets available in 7 strengths

Also, if you search the FDA drug page, the ANDA is 090533.
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Old 10-26-11, 11:24 PM
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Re: Mikart Pharmaceuticals generic dexedrine tablets available in 7 strengths

When I looked earlier this afternoon, all I could find was their withdrawn application. So, if this makes it to the market, it might be a good thing. What do you know about Mikart? Their website doesn't appear to have as much information as other manufacturers. Although, I realize they are a packager, as well. I couldn't locate a product guide. Could be I wasn't looking in the right spot.
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Old 10-26-11, 11:29 PM
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Re: Mikart Pharmaceuticals generic dexedrine tablets available in 7 strengths

I gather they make Focalin tablets for Novartis. I can't seem to find anything else. If this is for real, the specific label will probably show up on Dailymed before long.
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Old 10-26-11, 11:38 PM
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Re: Mikart Pharmaceuticals generic dexedrine tablets available in 7 strengths

Even more interesting is that, if you do an NDC search, it looks like Mallinckrodt has started marketing Dex ER again as of 10/7. Dailymed link here.

It seems that Teva's price increases have attracted competition.
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Old 10-26-11, 11:40 PM
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Re: Mikart Pharmaceuticals generic dexedrine tablets available in 7 strengths

That's actually the first place that I looked. lol

I did see that about Mallinckrodt. But I kept thinking that I wasn't reading it right. The last thing I found at FDA was their approval in 2002 for tabs. But what you found clearly says marketing start date 2011. And it's listed as Covidien (which may be why I didn't see it) who purchased Mallnckrodt. Good find!
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Old 10-27-11, 12:26 AM
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Re: Mikart Pharmaceuticals generic dexedrine tablets available in 7 strengths

Good to hear that Teva won't be having a monopoly in the Dexedrine generic department anymore.
I can't wait to try out the Mikart generic Dex.

Is there information when this new generic will be available in Pharmacies?
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Old 10-27-11, 12:35 AM
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Re: Mikart Pharmaceuticals generic dexedrine tablets available in 7 strengths

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Originally Posted by StoicNate View Post
Is there information when this new generic will be available in Pharmacies?
It's not even clear that it actually exists.

I might give Mikart a phone call tomorrow to see what's what.
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Old 10-27-11, 01:28 AM
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Re: Mikart Pharmaceuticals generic dexedrine tablets available in 7 strengths

Wait, wouldn't they have to go through a whole new approval process for all these strengths?

This sounds way too good to be true. I just picked up 240 5mg tablets for one months. I take EIGHT a day because 10mg tablets are way more expensive for some bizarre reason.
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