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https://www.fda.gov/media/71494/download
CHLORIDE MIOSTAT, CARBACHOL MIRABEGRON, MIRABEGRON MIRALAX, POLYETHYLENE GLYCOL...TETROFOSMIN KIT MYRBETRIQ, MIRABEGRON MYRBETRIQ GRANULES, MIRABEGRON ...
https://www.fda.gov/media/71502/download
MINOCYCLINE HYDROCHLORIDE MIRABEGRON, MIRABEGRON MORPHINE SULFATE, MORPHINE...INC MYRBETRIQ GRANULES, MIRABEGRON MYRBETRIQ, MIRABEGRON APIL * ALLERGAN ...
https://www.fda.gov/media/146610/download
Mirabegron Written Request...Mirabegron Written Request DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and...Pediatric Study Request for MYRBETRIQ® (mir ...
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/updated-information-recommended-acceptable-intake-limits-nitrosamine-drug-substance-related
Minocycline 3 400 ng/day N-nitroso-mirabegron Mirabegron 3 400 ng/day N-nitroso-mitoxantrone-1
https://www.fda.gov/media/147723/download
NDA 213801 MYRBETRIQ® Granules (mirabegron for extended-release oral suspension)...suspension) sNDA 202611/s-017 MYRBETRIQ® (mirabegron ...
https://www.fda.gov/drugs/development-resources/reviews-pediatric-studies-conducted-under-bpca-and-prea-2012-present
Medical (PDF - 8 MB) None None PREA Mirabegron - Myrbetriq Astellas Pharma Global...None None PREA Mirabegron extended-release tablets and mirabegron ...
https://www.fda.gov/media/158153/download
...3/16/2021 NDA 213801 MYRBETRIQ GRANULES MIRABEGRON EXTENDED-RELEASE FOR ORAL SUSPENSION
https://www.fda.gov/drugs/first-generic-drug-approvals/2019-first-generic-drug-approvals
Date ANDA Indication+ 107 209446 Mirabegron Extended-Release Tablets, 25 mg Sawai...Sawai USA, Inc. Myrbetriq (Mirabegron) Extended-Release Tablets ...
https://www.fda.gov/media/147728/download
Generic Name Mirabegron extended-release tablets and mirabegron extended-release...g of granules containing 830 mg mirabegron per bottle Route of ...
https://www.fda.gov/media/85138/download
...028071 MSN LABORATORIES PRIVATE LTD MIRABEGRON [ROUTE CODE "MG"] 9/29/15 12/17/15...028392 DR REDDYS LABORATORIES LTD MIRABEGRON [PRODUCT CODE: AEB] ...
https://www.fda.gov/media/147729/download
...213801 Drug Name: Myrbetriq Granules (Mirabegron for extended release oral suspension)...Myrbetriq® 25 mg and 50 mg tablets (Mirabegron) is currently ...
https://www.fda.gov/media/178811/download
...hyponatremia) mild Myrbetriq MIRABEGRON MIRABEGRON Heart Damage wp less increase
https://www.fda.gov/media/177768/download
...32 (HF); 0.65 (LF) without food Mirabegron ER 0.83 (HF); 0.49 (LF) 0.55 (HF);
https://www.fda.gov/drugs/drug-interactions-labeling/drug-development-and-drug-interactions-table-substrates-inhibitors-and-inducers
CYP2D6 fluoxetine(f), paroxetine Mirabegron CYP3A clarithromycin(g), itraconazole(g)
https://www.fda.gov/media/153422/download
Efficacy, Safety, and Tolerability of Mirabegron in Older Adult Subjects with Overactive...Efficacy, Safety, and Tolerability of Mirabegron in Men ...
https://www.fda.gov/news-events/press-announcements/fda-approves-new-indication-drug-treat-neurogenic-detrusor-overactivity-pediatric-patients
...a new indication for Myrbetriq (mirabegron extended-release tablets) and Myrbetriq...Myrbetriq Granules (mirabegron for extended-release oral ...
https://www.fda.gov/drugs/drug-and-biologic-approval-and-ind-activity-reports/2022-first-generic-drug-approvals
...years of age and older 95 209485 Mirabegron Extended-Release Tablets, 25 mg and...and 50 mg Lupin Limited Myrbetriq (Mirabegron) Extended-Release ...
https://www.fda.gov/media/174295/download
...pirbuterol beta-2 adrenergic agonist MIRABEGRON beta-3 adrenergic agonist VIBEGRON
https://www.fda.gov/media/167138/download
PRODUCT LIST MIRABEGRON TABLET, EXTENDED RELEASE;ORAL MIRABEGRON >D> >A> >D>
https://www.fda.gov/media/164398/download
...3/20/2014 MSN LABORATORIES PRIVATE LTD MIRABEGRON [ROUTE CODE "MG"] 28072 A II 3/22/2014...6/30/2014 DR REDDYS LABORATORIES LTD MIRABEGRON [PRODUCT ...