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Pharmacy Times
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Acetaminophen, Caffeine, and Dihydrocodeine Tablets

Marketed by: Boca Pharmacal Inc (Coral Springs, Fla)

Compared to: Panlor SS (Pamlab, LLC)

Indication: April 10, 2007?Boca Pharmacal Inc announced that it received FDA approval for its abbreviated new drug application to market its acetamino-phen, caffeine, and dihydrocodeine tablets. These tablets are indicated for the treatment of moderate-to-severe pain. Dihydrocodeine is a semisynthetic narcotic analgesic related to codeine; acetaminophen is a nonopiate, nonsalicylate analgesic and antipyretic; caffeine works as an analgesic adjuvant, as well as a central nervous system and cardiovascular stimulant. The recommended dose is 1 tablet every 4 hours (as needed).

Dosage Form: Each tablet contains 712.8 mg acetaminophen, 60 mg caffeine, and 32 mg dihydrocodeine

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Amlodipine Besylate Tablets

Marketed by: Mylan Laboratories Inc (Pittsburgh, Pa); authorized generic: Greenstone Ltd, a wholly owned subsidiary of Pfizer Inc (New York, NY)

Compared to: Norvasc (Pfizer Inc)

Indication: March 23, 2007?Mylan Laboratories launched Amlodipine Besylate Tablets, 2.5, 5, and 10 mg. Mylan obtained 180 days of exclusivity, as it was the first generic company to file on all strengths of amlodi-pine. Simultaneous with Mylan?s launch, Greenstone also announced the launch of its authorized generic. Amlodipine besylate is the besylate salt of amlodi-pine, a long-acting calcium channel blocker. These tablets are indicated for the treatment of hypertension as well as confirmed or suspected vasospastic angina and for the symptomatic treatment of chronic stable angina.

Dosage Form: Tablets: 2.5, 5, and 10 mg

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Danazol Capsules, 50 and 100 mg

Marketed by: Lannett Co Inc (Philadelphia, Pa)

Compared to: Danocrine Capsules (sanofi-aventis US)

Indication: April 23, 2007?Lannett Co Inc announced that the FDA approved its abbreviated new drug application for Danazol Capsules, 50 and 100 mg. Danazol is a gonadotropin inhibitor, a sex hormone, and is indicated for the treatment of endometriosis amenable to hormonal management, for fibrocystic breast disease, and for the prevention of attacks of angioedema of all types (cutaneous, abdominal, laryngeal) in males and females. These capsules also may be used to treat excessive menstrual bleeding or other conditions.

Dosage Form: Capsules: 50 and 100 mg (200 mg also available)

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Zolpidem Tartrate Tablets, 5 and 10 mg

Marketed by: Prasco Laboratories (Cincinnati, Ohio); as well as Mylan Pharmaceuticals Inc, TEVA Pharmaceuticals USA, Roxane Laboratories Inc, Watson Laboratories Inc, Ranbaxy Laboratories Ltd, Dr. Reddy?s Laboratories Ltd, Apotex Inc, Synthon Pharmaceuticals Inc, Genpharm Inc, Mutual Pharmaceutical Co Inc, Caraco Pharmaceutical Laboratories Ltd, Carlsbad Technology Inc, and Lek Pharmaceuticals

Compared to: Ambien (sanofi-aventis US)

Indication: April 23, 2007?Prasco announced that it signed a distribution and supply agreement with sanofi-aventis US to launch the authorized generic Zolpidem Tartrate in 5- and 10-mg strengths. The product is indicated for the short-term treatment of insomnia in adults; it may treat sleep problems such as trouble falling asleep, waking up too early in the morning, and waking up too often during the night. Zolpidem tartrate tablets have been shown to decrease sleep latency for up to 35 days in controlled clinical studies.

Dosage Form: Tablets: 5 and 10 mg

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