Manufacturing Establishments (1)
Cadila Pharmaceuticals Limited
918451696
Products (3)
Sildenafil
71209-106
ANDA218045
ANDA (C73584)
ORAL
February 12, 2024
Sildenafil
71209-108
ANDA218045
ANDA (C73584)
ORAL
February 12, 2024
Sildenafil
71209-107
ANDA218045
ANDA (C73584)
ORAL
February 12, 2024
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Sildenafil Tablets, USP - Container Label 30 Tablets
NDC 71209-106-01
Sildenafil Tablets, USP
** 25 mg**
RX only 30 Tablets
Sildenafil Tablets, USP - Container Label 100 Tablets
NDC 71209-106-05
Sildenafil Tablets, USP
** 25 mg**
RX only 100 Tablets
Sildenafil Tablets, USP - Container Label 1000 Tablets
NDC 71209-106-05
Sildenafil Tablets, USP
** 25 mg**
RX only 1000 Tablets
Sildenafil Tablets, USP - Container Label 30 Tablets
NDC 71209-107-01
Sildenafil Tablets, USP
** 50 mg**
RX only 30 Tablets
Sildenafil Tablets, USP - Container Label 100 Tablets
NDC 71209-107-05
Sildenafil Tablets, USP
** 50 mg**
RX only 100 Tablets
Sildenafil Tablets, USP - Container Label 1000 Tablets
NDC 71209-107-11
Sildenafil Tablets, USP
** 50 mg**
RX only 1000 Tablets
Sildenafil Tablets, USP - Container Label 30 Tablets
NDC 71209-108-01
Sildenafil Tablets, USP
** 100 mg**
RX only 30 Tablets
Sildenafil Tablets, USP - Container Label 100 Tablets
NDC 71209-108-05
Sildenafil Tablets, USP
** 100 mg**
RX only 100 Tablets
Sildenafil Tablets, USP - Container Label 1000 Tablets
NDC 71209-108-11
Sildenafil Tablets, USP
** 100 mg**
RX only 1000 Tablets
RECENT MAJOR CHANGES SECTION
RECENT MAJOR CHANGES
Warnings and Precautions, Effects on the Eye (5.3) 8/2017
INDICATIONS & USAGE SECTION
1 INDICATIONS & USAGE
Sildenafil tablets are indicated for the treatment of erectile dysfunction.
DOSAGE FORMS & STRENGTHS SECTION
3 DOSAGE FORMS & STRENGTHS
Sildenafil tablets, USP are supplied as blue, film-coated, rounded-diamond- shaped tablets containing sildenafil citrate equivalent to 25 mg, 50 mg, or 100 mg of sildenafil. Tablets are debossed with “S25”, “S50” or “S100” on one side and plain on other to indicate the dosage strengths.
OVERDOSAGE SECTION
10 OVERDOSAGE
In studies with healthy volunteers of single doses up to 800 mg, adverse reactions were similar to those seen at lower doses but incidence rates and severities were increased.
In cases of overdose, standard supportive measures should be adopted as required. Renal dialysis is not expected to accelerate clearance as sildenafil is highly bound to plasma proteins and it is not eliminated in the urine.