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searching for Abbreviated New Drug Application 13 found (44 total)

alternate case: abbreviated New Drug Application

FDA citizen petition (591 words) [view diff] exact match in snippet view article find links to article

Innovator companies may also present arguments to the FDA that the Abbreviated New Drug Application (ANDA) should not be accepted by filing a "citizen petition"

Hydrocodone/ibuprofen (1,662 words) [view diff] case mismatch in snippet view article find links to article

was invalid as obvious. This ruling paved the way for Teva's abbreviated new drug application to be approved by the FDA which would allow them to manufacture

Complete Response Letter (757 words) [view diff] exact match in snippet view article find links to article

(known as the PDUFA date) to decide a New Drug Application, Abbreviated New Drug Application or Biologics License Application. The FDA may either approve

Dorzolamide/timolol (1,186 words) [view diff] case mismatch in snippet view article find links to article

Pharma was the first of many generic competitors to submit an abbreviated new drug application (ANDA) for dorzolamide hydrochloride/timolol maleate eye drops

Aminophylline (1,109 words) [view diff] exact match in snippet view article find links to article

increases heart rate and contractility. "FDA-Approved Drugs Abbreviated New Drug Application (ANDA): 087242". fda.gov. October 26, 1983. Retrieved December

Akorn (495 words) [view diff] exact match in snippet view article find links to article

requirements for an acquisition. In October 2018, Akorn received Abbreviated New Drug Application (ANDA) approval from Food and Drug Administration (FDA) for

Propylene glycol (4,676 words) [view diff] exact match in snippet view article find links to article

(US Pharmacopoeia) propylene glycol can reduce the risk of Abbreviated New Drug Application (ANDA) rejection. Propylene glycol can also be obtained from

Norelgestromin/ethinylestradiol (452 words) [view diff] exact match in snippet view article find links to article

Estradiol Transdermal System), 150 mcg/35 mcg per day" (PDF). Abbreviated New Drug Application. U.S. Food and Drug Administration. 16 April 2014. Portal:

Metoclopramide (3,882 words) [view diff] exact match in snippet view article find links to article

Retrieved 21 January 2018. "TEVA Metoclopramide Hydrochloride". Abbreviated New Drug Application (ANDA): 070184. U.S. Food and Drug Administration. Archived

Food and Drug Administration Safety and Innovation Act (2,764 words) [view diff] case mismatch in snippet view article find links to article

pending on October 1, 2012; (2) a drug master file fee; (3) an abbreviated new drug application and prior approval supplement filing fee, as well as an additional

History of the Food and Drug Administration (3,469 words) [view diff] exact match in snippet view article find links to article

manufacturers, the Act created a new approval mechanism, the Abbreviated New Drug Application (ANDA), in which the generic drug manufacturer need only demonstrate

Bausch Health (5,243 words) [view diff] case mismatch in snippet view article find links to article

Andrews' decision bolsters his previous ruling that Norwich's abbreviated new drug application for rifaximin infringed on Bausch Health's Xifaxan patents

Conjugated estrogens (6,467 words) [view diff] exact match in snippet view article find links to article

for the activity of Premarin, and it laid the groundwork for Abbreviated New Drug Application (ANDA) submissions of generic versions. In 1984 an NIH consensus