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[email protected]: FDA-Approved Drugs

* Drugs@FDA includes information about drugs, including biological products, approved for human use in the United States (see FAQ), but does not include information about FDA-approved products regulated by the Center for Biologics Evaluation and Research (for example, vaccines, allergenic products, blood and blood products, plasma derivatives, cellular and gene therapy …

Actived: 3 days ago

URL: Accessdata.fda.gov


[email protected]: FDA-Approved Drugs

(9 days ago) All Approvals and Tentative ApprovalsApril 2022. This report includes approvals of NDAs, BLAs, ANDAs, and approved supplements to those applications, and tentative ANDA/NDA approvals during the selected month. This report does not include BLAs/NDAs and supplements to those applications approved by CBER. Click on the Drug Name and Application

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[email protected]: FDA-Approved Drugs

(5 days ago) Recent New and Generic Drug Approvals. This report displays final approvals and tentative approvals of original and supplemental applications for the two weeks beginning on the earliest date listed below. Some approvals may be added to the Drugs@FDA database after this timespan. For comprehensive approval reports, please use the monthly "All

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[email protected]: FDA-Approved Drugs

(5 days ago) U.S. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 1-888-INFO-FDA (1-888-463-6332) Contact FDA

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[email protected]: FDA-Approved Drugs

(8 days ago) Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company; DOFETILIDE: DOFETILIDE: 0.125MG: TABLET;ORAL: Prescription

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[email protected]: FDA-Approved Drugs

(2 days ago) lamivudine, zidovudine tabs 150mg/300mg co-packaged with nevirapine tabs 200mg (lamivudine; zidovudine; nevirapine) | nda #022356 | tablet; oral | hetero drugs ltd Lamivudine, Zidovudine, Nevirapine Tabs 150mg/300mg/200mg

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[email protected]: FDA-Approved Drugs

(2 days ago) TOBRAMYCIN SULFATE (PHARMACY BULK) (TOBRAMYCIN SULFATE) | ANDA #065120 | INJECTABLE;INJECTION | FRESENIUS KABI USA. TOBRAMYCIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER. TOBRAMYCIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (TOBRAMYCIN SULFATE) | ANDA #063081 | …

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[email protected]: FDA-Approved Drugs

(2 days ago) valganciclovir hydrochloride. valganciclovir hydrochloride (valganciclovir hydrochloride) | anda #203511 | tablet;oral | dr reddys valganciclovir hydrochloride (valganciclovir hydrochloride) | anda #205151 | tablet;oral | mylan valganciclovir hydrochloride (valganciclovir hydrochloride) | anda #205166 | tablet;oral | hetero labs ltd v

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[email protected]: FDA-Approved Drugs

(8 days ago) Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url; 03/23/2022: ORIG-1: Approval Label (PDF)

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Medication Guides

(7 days ago) Medication Guides. Medication guides are FDA- approved documents that address issues that are specific to particular drugs, and can help patients avoid serious adverse events (side effects). This database does not include Medication Guides for FDA-approved allergenic or cellular/tissue products (see FDA Online Label Repository or DailyMed for

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[email protected]: FDA-Approved Drugs

(3 days ago) a-methapred. a-methapred (methylprednisolone sodium succinate) | anda #089173 | injectable;injection | hospira a-methapred (methylprednisolone sodium succinate) | anda #089174 | injectable;injection | hospira a-methapred (methylprednisolone sodium succinate) | anda #089573 | injectable;injection | abbott a-methapred (methylprednisolone sodium succinate) | anda

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[email protected]: FDA-Approved Drugs

(3 days ago) calcium acetate. calcium acetate (calcium acetate) | anda #203298 | capsule;oral | lotus pharm co ltd calcium acetate (calcium acetate) | anda #091312 | capsule;oral | chartwell rx calcium acetate (calcium acetate) | anda #091561 | tablet;oral | padagis us calcium acetate (calcium acetate) | anda #201658 | capsule;oral | amneal pharms

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[email protected]: FDA-Approved Drugs

(2 days ago) palonosetron hydrochloride. palonosetron hydrochloride (palonosetron hydrochloride) | nda #208109 | solution;intravenous | fresenius kabi usa palonosetron hydrochloride (palonosetron hydrochloride) | nda #207963 | solution;intravenous | hikma palonosetron hydrochloride (palonosetron hydrochloride) | anda #208789 | injectable;intravenous | ingenus pharms llc

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[email protected]: FDA-Approved Drugs

(3 days ago) enalapril maleate. enalapril maleate (enalapril maleate) | anda #075178 | tablet;oral | nostrum labs inc enalapril maleate (enalapril maleate) | anda #075048 | tablet;oral | sandoz enalapril maleate (enalapril maleate) | anda #075369 | tablet;oral | krka dd novo mesto enalapril maleate (enalapril maleate) | anda #075370 | tablet;oral | krka dd novo mesto

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[email protected]: FDA-Approved Drugs

(9 days ago) U.S. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 1-888-INFO-FDA (1-888-463-6332) Contact FDA

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[email protected]: FDA-Approved Drugs

(9 days ago) U.S. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 1-888-INFO-FDA (1-888-463-6332) Contact FDA

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[email protected]: FDA-Approved Drugs

(2 days ago) HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER (HEPARIN SODIUM) | NDA #018916 | INJECTABLE;INJECTION | HOSPIRA. HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.9%. HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.9% (HEPARIN SODIUM) | NDA #018916 | INJECTABLE;INJECTION | …

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[email protected]: FDA-Approved Drugs

(8 days ago) Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS; THIAMINE HYDROCHLORIDE: THIAMINE HYDROCHLORIDE: 100MG/ML: INJECTABLE;INJECTION

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[email protected]: FDA-Approved Drugs

(2 days ago) famotidine preservative free. famotidine preservative free (famotidine) | anda #075813 | injectable;injection | fresenius kabi usa famotidine preservative free (famotidine) | anda #075825 | injectable;injection | athenex inc famotidine preservative free (famotidine) | anda #075708 | injectable;injection | apothecon famotidine preservative free (famotidine) | anda #075669 | …

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[email protected]: FDA-Approved Drugs

(2 days ago) medical air, usp. medical air, usp (medical air) | nda #211270 | gas;inhalation | linde gas puerto rico inc medical air, usp (medical air) | nda #205845 | gas

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[email protected]: FDA-Approved Drugs

(9 days ago) All Approvals and Tentative ApprovalsJanuary 2021. This report includes approvals of NDAs, BLAs, ANDAs, and approved supplements to those applications, and tentative ANDA/NDA approvals during the selected month. This report does not include BLAs/NDAs and supplements to those applications approved by CBER. Click on the Drug Name and Application

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[email protected]: FDA-Approved Drugs

(2 days ago) x-trozine. x-trozine (phendimetrazine tartrate) | anda #086550 | tablet;oral | shire richwood x-trozine (phendimetrazine tartrate) | anda #086551 | tablet;oral | shire richwood x-trozine (phendimetrazine tartrate) | anda #086552 | tablet;oral | shire richwood x-trozine (phendimetrazine tartrate) | anda #086553 | tablet;oral | shire richwood

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[email protected]: FDA-Approved Drugs

(8 days ago) Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note; 03/18/2022: ORIG-1: Approval Label (PDF)

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[email protected]: FDA-Approved Drugs

(2 days ago) zantac 150. zantac 150 (ranitidine hydrochloride) | nda #018703 | tablet;oral | glaxo grp ltd zantac 150 (ranitidine hydrochloride) | nda #020095 | capsule;oral | glaxosmithkline zantac 150 (ranitidine hydrochloride) | nda #020251 | tablet, effervescent;oral | glaxo grp ltd zantac 150 (ranitidine hydrochloride) | nda #021698 | tablet;oral | chattem sanofi

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NDA 215272 NDA APPROVAL

(4 days ago) Prescription Drugs. 3 . As required under 21 CFR 314.81(b)(3)(i), you must submit final promotional materials, and the Prescribing Information, at the time of initial dissemination or publication, accompanied by a Form FDA 2253. Form FDA 2253 is available at FDA.gov. 4 . Information and Instructions for completing the form can be found at FDA

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[email protected] Glossary

(7 days ago) Over-the-Counter Drugs (OTC) FDA defines over-the-counter (OTC) drugs as safe and effective for use by the general public without a doctor's prescription. Patient Package Insert (PPI) A patient package insert contains information for patients' understanding of how to safely use a drug product. Pharmaceutical Equivalents

Category:  Pharmaceutical,  Doctor Go Now

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