The company's Abbreviated New Drug Application
for Clobazam Tablets, CIV is the generic for Onfi Tablets by Lundbeck.
Abbreviated New Drug Application
("ANDA") for Fluocinonide Emollient Cream USP, 0.05% ("Fluocinonide E") and the Canadian Abbreviated New Drug Submission ("ANDS") to Tiamol(R) (Fluocinonide Emollient Cream USP, 0.05%) in Canada.
The United States Food and Drug Administration (FDA) has approved the Abbreviated New Drug Application
for United States-based Lannett Company Inc's (NYSE: LCI) Dronabinol Capsules USP, 2.5mg, 5mg and 10mg, it was reported yesterday.
and Andrx Labs in connection with the filing of an Abbreviated New Drug Application
(ANDA) with the Food and Drug Administration for pioglitazone hydrochloride and extended-release metformin hydrochloride tablets, 15 mg/1,000 mg and 30 mg/1,000 rag.
Food and Drug Administration (FDA) approving its Abbreviated New Drug Application
(ANDA) for Diflorasone Diacetate Cream USP, 0.05%.
In the long-term, if the 64 abbreviated new drug application
pipeline remains intact, the business "should grow nicely," Steinberg tells investors in a research note.
Pharmaceutical company Lannett Company Inc (NYSE:LCI) Monday received approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application
(ANDA) for Dronabinol Capsules USP in 2.5 mg, 5 mg and 10 mg.
IVAX also has an Abbreviated New Drug Application
(ANDA) pending in the United States for a generic form of Taxol(R) (paclitaxel), for which the company expects six months of generic marketing exclusivity upon approval in 2000.
Perrigo Company announced that Valeant Pharmaceuticals North America, Valeant Pharmaceuticals Ireland, Dow Pharmaceuticals Sciences and Kaken Pharmaceuticals initiated patent litigation on September 21, 2018 in the United States District Court for the District of New Jersey regarding Perrigo's Paragraph IV Abbreviated New Drug Application
for efinaconazole topical solution 10%, asserting patents listed in the Orange Book for Jublia.
M2 EQUITYBITES-March 21, 2018-Amerigen wins US FDA final approval for Abbreviated New Drug Application
for cyclophosphamide capsules to treat cancers