ANDAs

This Week at FDA: Amazon warning letter, ANDA amendments, and more
RAPS.org
Sun, 08/14/22 - 10:44 pm
FDA
regulatory
monkeypox
Jynneos
ANDAs
Amazon
devices
FDA scraps another last-minute Trump-era policy
RAPS.org
Sat, 05/1/21 - 09:17 pm
FDA
regulatory
NDAs
ANDAs
Generic drugmakers get guidance on tentative approvals, CRLs
RAPS.org
Mon, 09/28/20 - 10:29 pm
FDA
regulatory
generics
ANDAs
2 Become 1: FDA MAPP on Consolidation of ANDAs
FDA Law Blog
Wed, 08/26/20 - 10:58 am
FDA
ANDAs
FDA Seeks to Pull Nearly 250 ANDAs Over Unsubmitted Annual Reports
RAPS.org
Wed, 01/8/20 - 11:38 pm
FDA
ANDAs
generics
FDA Smashes Record for Most ANDA Complete Responses in one Year
RAPS.org
Wed, 09/19/18 - 11:30 pm
FDA
ANDAs
FDA Sets Monthly ANDA Records in October
RAPS.org
Wed, 11/15/17 - 10:34 am
FDA
ANDAs
generics
drug approvals
In a Rare Move, FDA Initiates Procedures to Suspend Approval of an ANDA
FDA Law Blog
Fri, 12/4/15 - 08:21 pm
FDA
ANDAs
Armenpharm
PLAN B Revisited: FDA Rules on One-Step Exclusivity and ANDA Labeling Carve-Outs
FDA Law Blog
Wed, 02/26/14 - 09:15 am
FDA
exclusivity
ANDAs
Plan B contraceptive
Teva Pharmaceuticals
Watson Files More ANDAs
Yahoo/Zacks.com
Mon, 06/27/11 - 09:22 am
ANDAs
Watson Pharmaceuticals
GSK
Novartis
Pfizer
Adovart
nabumetone
Pataday
Subsequent ANDA filers have legally cognizable interest in when first-filer’s exclusivity period begins
Lexology
Sun, 12/5/10 - 12:24 pm
ANDAs
legal
Somaxon Pharmaceuticals Announces Paragraph IV ANDA Filing for Silenor
Yahoo
Mon, 10/18/10 - 03:09 pm
Somaxon
ANDAs
Silenor
District Court Denies Teva's Motion to Stay Integrelin Case
Seeking Alpha
Wed, 04/21/10 - 10:27 am
Teva Pharmaceuticals
Integrilin
ANDAs
Millennium
MDRNA, Inc. Receives Full FDA Approval of Generic Calcitonin-Salmon Nasal Spray for Osteoporosis; Par Pharmaceutical Companies, Inc. Launches Product
Yahoo
Tue, 06/9/09 - 08:46 am
Par Pharmaceutical
osteoporosis
FDA
ANDAs
OSI Pharmaceuticals Announces Notification of ANDA Filing for Tarceva
Yahoo
Tue, 02/10/09 - 07:41 am
OSI Pharmaceuticals
Teva Pharmaceuticals
ANDAs
Tarceva