FDA Medication List 2019



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FDA Medication List 2019

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valsartan products under recall – FDA

www.fda.gov

09/2019. A-S Medication Solutions LLC (Teva/Actavis & Prinston/Solco).
Valsartan 80mg Tablet. 54569-6582-1. 342B17018. 08/2019. A-S Medication
Solutions …

Search List of Recalled Angiotensin II Receptor Blockers … – FDA

www.fda.gov

Find the list on the following webpage: Search List of Recalled Angiotensin II
Receptor Blockers (ARBs) including · Valsartan, Losartan and Irbesartan.

List of Off-Patent, Off-Exclusivity Drugs without an Approved … – FDA

www.fda.gov

methodology described below, of approved new drug application (NDA) drug
products that … Part I of the list identifies those drug products for which FDA could
 …

Approved Drug Product List – Orange Book Reference Listed … – FDA

www.fda.gov

Approved Drug Product List – Orange Book. Page 1 of 9. Reference Listed Drugs
by ANDA Reference Standard List. July 2019. This list refers to drug products …

Orange Book Cumulative Supplement 07 July 2019 – FDA

www.fda.gov

Jul 7, 2019 … Office of Generic Drugs. Office of Generic Drug Policy. 2019 …. New additions to
the Prescription Drug Product List and OTC Drug Product.

2018 new drug therapy approvals – FDA

www.fda.gov

January 2019 … New and Expanded Uses of Already FDA-Approved Drugs . …..
Novel Drug Approvals for 2018 for the non-proprietary names, dosage forms, …

Approved Drug Products with Therapeutic Equivalence … – FDA

www.fda.gov

May 25, 2010 … The publication, Approved Drug Products With Therapeutic Equivalence.
Evaluations (the List, commonly known as the Orange Book), …

Paragraph IV Patent Certifications August 27, 2019 Page 1 DRUG …

www.fda.gov

4 days ago … Paragraph IV Patent Certifications. August 27, 2019. Page 2. DRUG NAME.
DOSAGE FORM. STRENGTH. RLD/NDA. DATE OF. SUBMISSION.

Section 503A Bulks List Final Rule Questions and Answers – FDA

www.fda.gov

Center for Drug Evaluation and Research (CDER). May 2019. Compounding …
rule, entitled “List of Bulk Drug Substances That Can Be Used To Compound …

Drug Supply Chain Security Act – FDA

www.fda.gov

(Title II of the Drug Quality and Security Act) …. Proprietary or established name
or names of … 2019 for wholesale distributors and 2020 for dispensers). 12 …

HIGHLIGHTS OF PRESCRIBING INFORMATION These … – FDA

www.accessdata.fda.gov

See 17 for PATIENT COUNSELING INFORMATION and Medication … Revised: 3
/2019 …. Further information, including a list of certified healthcare facilities, …

Label – FDA

www.accessdata.fda.gov

conditions of diseases with medications that may increase serum potassium
concentrations. … Revised: [05/2019]. FULL PRESCRIBING ….. Each box on the
chart contains a list of birth control methods that are similar in effectiveness. The
most …

Reference ID: 4409346 – FDA

www.accessdata.fda.gov

Initial U.S. Approval: 2019 …. See 17 for PATIENT COUNSELING INFORMATION
and Medication. Guide. Revised: 3/ ….. Table 3 lists adverse reactions that
occurred in at least 5% of MAYZENT-treated patients and at a rate at least 1%
higher.

Bulk Drug Substances Nominated for Use in Compounding … – FDA

www.fda.gov

Updated April 22, 2019. 1. Bulk Drug Substances Nominated for Use in
Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act.

Reference ID: 4383595 – FDA

www.accessdata.fda.gov

See 17 for PATIENT COUNSELING INFORMATION and Medication. Guide.
Revised: 1/2019. FULL PRESCRIBING ….. Table 1 lists the adverse reactions
reported during the double-blind, cross-over phase. No patient discontinued the
study …

HIGHLIGHTS OF PRESCRIBING INFORMATION These … – FDA

www.accessdata.fda.gov

Dosage and Administration (2). 02/2019. Warnings and Precautions (5.3). 02/
2019. Warnings …. See 17 for PATIENT COUNSELING INFORMATION and
Medication. Guide. …… See the end of this Medication Guide for a list of
ingredients in …

Marketing Status Notifications Under Section 506I of the … – FDA

www.fda.gov

January 2019. Procedural … January 2019. Procedural …. available, among other
things, a list of drug products either approved under section 505(c) of the. 35.

Reference ID: 4374908 – FDA

www.accessdata.fda.gov

5/2018. Contraindications (4). 1/2019. Warnings and Precautions (5.1, 5.10,) …
block, prolonged QTc interval, or if taking drugs with known risk of torsades …..
Table 1 lists adverse reactions in clinical studies in adults that occurred in ≥ 1%
of …