NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL

Generic: NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL

Glenmark Pharmaceuticals Inc.Manufacturer
ORALRoute
NORETHINDRONE ACETATEActive Substance
2015-04-02Original Approval

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL is FDA application ANDA203038, sponsored by GLENMARK PHARMS LTD. Any recalls listed below come from FDA drug enforcement reports, and reaction counts are the number of FAERS adverse event reports that mention the drug and that reaction; a report does not prove the drug caused it.

Recalls

Class III2017-01-30
Norethindrone Acetate and Ethinyl Estradiol Tablets, USP, 1 mg/0.02 mg, 1 blister pack containing 21 tablets (NDC 0378-7

Chemical Contamination: out of specification results for impurities were found to be the result of c

Top Reported Reactions

1
FATIGUE
36 reports
2
HEADACHE
31 reports
3
NAUSEA
28 reports
4
DIARRHOEA
24 reports
5
DIZZINESS
20 reports
6
RASH
17 reports
7
DYSPNOEA
16 reports
8
ABDOMINAL PAIN
14 reports
9
OFF LABEL USE
14 reports
10
PRURITUS
14 reports