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https://www.fda.gov/media/177469/download
Multi-Disciplinary Review and Evaluation (Nintedanib)...Multi-Disciplinary Review and Evaluation (Nintedanib) NDA/BLA Multi-disciplinary ...
https://www.fda.gov/media/173201/download
Nintedanib Written Request NDA 205832 IND 129333 WRITTEN REQUEST Boehringer...Pediatric Study Request for Ofev (nintedanib). BACKGROUND This study ...
https://www.fda.gov/media/173202/download
Nintedanib Written Request NDA 205832 IND 129333 WRITTEN REQUEST – AMENDMENT...pediatric studies for for Ofev (nintedanib). We have reviewed your ...
https://www.fda.gov/drugs/fdas-adverse-event-reporting-system-faers/january-march-2020-potential-signals-serious-risksnew-safety-information-identified-fda-adverse
Nexavar (sorafenib tosylate) Ofev (nintedanib) Stivarga (regorafenib) Sutent (sunitinib
https://www.fda.gov/drugs/fdas-adverse-event-reporting-system-faers/january-march-2017-potential-signals-serious-risksnew-safety-information-identified-fda-adverse
Neulasta Onpro kit labeling Ofev (nintedanib) capsules, for oral use Liver dysfunction
https://www.fda.gov/media/134493/download
...minutes and three hours. • Ofev (nintedanib) capsules, originally approved in
https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-patients-rare-type-lung-disease
FDA approves Ofev (nintedanib) capsules, the first treatment for interstitial...Administration today approved Ofev (nintedanib) capsules to slow the ...
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cder-nitrosamine-impurity-acceptable-intake-limits
Nimodipine 5 1500 ng/day N-nitroso-nintedanib Nintedanib 5 1500 ng/day N-nitroso-nisoldipine
https://www.fda.gov/media/180157/download
...positive (Ph+) hematologic malignancies nintedanib 10/6/23 Boehringer Ingelheim Pharmaceuticals
https://www.fda.gov/media/182650/download
Novartis Pharmaceuticals 6/19/09 Nintedanib Boehringer Ingelheim Pharmaceuticals
https://www.fda.gov/media/131177/download
...fibrosis (IPF) NDA 205832 ORIG - 1 OFEV NINTEDANIB BOEHRINGER INGELHEIM PHARMACEUTICALS
https://www.fda.gov/drugs/development-resources/list-determinations-including-written-request
...456 KB] Amendment 3 [PDF - 490 KB] Nintedanib Boehringer Ingelheim Pharmaceuticals
https://www.fda.gov/media/179147/download
...tentatively approved ANDAs. 1. NINTEDANIB (NINTEDANIB ESYLATE) | ANDA #212555 | CAPSULE;ORAL...Approval) | GLENMARK PHARMS LTD 2. NINTEDANIB (NINTEDAN ...
https://www.fda.gov/media/134156/download
Novartis Pharmaceuticals 6/19/09 Nintedanib Boehringer Ingelheim Pharmaceuticals
https://www.fda.gov/media/128976/download
...microorganisms NDA 205832** SUPPL-12 OFEV NINTEDANIB BOEHRINGER INGELHEIM PHARMACEUTICALS
https://www.fda.gov/media/179169/download
...tentatively approved ANDAs. 1. NINTEDANIB (NINTEDANIB ESYLATE) | ANDA #212555 | CAPSULE;ORAL...Approval) | GLENMARK PHARMS LTD 2. NINTEDANIB (NINTEDAN ...
https://www.fda.gov/media/179148/download
...tentatively approved ANDAs. 1. NINTEDANIB (NINTEDANIB ESYLATE) | ANDA #212555 | CAPSULE;ORAL...Approval) | GLENMARK PHARMS LTD 2. NINTEDANIB (NINTEDAN ...
https://www.fda.gov/media/95302/download
...(IPF) NDA 205832 ORIGINAL-1 OFEV NINTEDANIB BOEHRINGER INGELHEIM PHARMACEUTICALS...disease NDA 205832 SUPPLEMENT-13 OFEV NINTEDANIB BOEHRINGER ...
https://www.fda.gov/media/161333/download
...and older NDA 205832 SUPPL-12 OFEV NINTEDANIB BOEHRINGER INGELHEIM PHARMACEUTICALS...infections NDA 205832 ORIG - 1 OFEV NINTEDANIB BOEHRINGER ...
https://www.fda.gov/media/85138/download
...031526 MSN LABORATORIES PRIVATE LTD NINTEDANIB ESYLATE 3/7/18 9/5/18 MF 031556 AJINOMOTO...032152 GLENMARK LIFE SCIENCES LTD NINTEDANIB ESYLATE ...
