This is the second Ready-To-Use Infusion bag (RTU Bags) ANDA drug product approved for Caplin Steriles
Jubilant Cadista will submit an appropriate action plan to the USFDA on these observations
Metoprolol Tartrate and Hydrochlorothiazide Tablet is the combination tablet of metoprolol tartrate, a beta adrenoceptor blocker and hydrochlorothiazide (HCTZ), a thiazide diuretic, indicated for the treatment of hypertension, to lower blood pressure
The EIR was issued with an inspection classification of Voluntary Action Indicated (VAI) post the inspection of the facility from September 16 to September 27, 2024
This facility is considered to be in a minimally acceptable state of compliance with regard to current GMP
FDC Ltd has received final approval from USFDA for the company's Abbreviated New Drug Application (ANDA) for Cefixime 400 mg Tablets
Lidocaine and Prilocaine cream had annual sales of US $22.05 million in the United States (IQVIA MAT October 2024)
Difluprednate Ophthalmic Emulsion, 0.05% is a topical corticosteroid that is indicated in the treatment of inflammation and pain associated with ocular surgery
This product is indicated in coagulation disorders caused by vitamin K deficiency or interference with vitamin K activity.
The fixed-dose combination of Abacavir 60 mg/Dolutegravir 5 mg/Lamivudine 30 mg tablets for oral suspension is a once-daily single-pill regimen
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