Drug information for PLAN B

Form	Dosage	Status	Therapeutic Equivalence	Active Ingred	Ref.	Sponsor	Document
TABLET; ORAL	0.75MG	Prescription	AB (Reference Drug)	LEVONORGESTREL	Levonorgestrel	TEVA WOMENS	21045 2009-11-20 Letter 2009-08-14 Label 2006-08-29 Review 2006-08-24 Label 2006-08-24 Letter 2006-08-23 Other Important Information from FDA 1999-07-28 Letter 1999-07-28 Review 1999-07-28 Label
TABLET; ORAL	0.75MG	Over The Counter	(Reference Drug)	LEVONORGESTREL	Levonorgestrel	TEVA WOMENS	"
TABLET; ORAL	0.75MG	Discontinued		LEVONORGESTREL	Levonorgestrel	TEVA WOMENS	"

Drug Adverse Effects information for PLAN B

Role code	Indications	Reaction	# Reports
PS	POST COITAL CONTRACEPTION	DIZZINESS	1
PS	POST COITAL CONTRACEPTION	SWELLING FACE	1
PS	POST COITAL CONTRACEPTION	THROAT TIGHTNESS	1
SS	CONTRACEPTION	ABORTION SPONTANEOUS	2
SS	CONTRACEPTION	BLIGHTED OVUM	2
SS	CONTRACEPTION	MATERNAL EXPOSURE BEFORE PREGNANCY	2
SS	CONTRACEPTION	VAGINAL HAEMORRHAGE	2
C	CONTRACEPTION	AMENORRHOEA	6
C	CONTRACEPTION	CHOLECYSTECTOMY	3
C	CONTRACEPTION	CHOLECYSTITIS CHRONIC	3
C	CONTRACEPTION	HYPOTENSION	1
C	CONTRACEPTION	SINUSITIS	1
C	CONTRACEPTION	SUBCLAVIAN VEIN THROMBOSIS	1
C	CONTRACEPTION	UPPER RESPIRATORY TRACT INFECTION	1
C	CONTRACEPTION	VARICOSE VEIN	1
C	CONTRACEPTION	VENOUS THROMBOSIS	1
C	ORAL CONTRACEPTION	ANXIETY	2
C	ORAL CONTRACEPTION	GALLBLADDER DISORDER	2
C	ORAL CONTRACEPTION	INJURY	2
C	ORAL CONTRACEPTION	PAIN	2
C	POST COITAL CONTRACEPTION	AMENORRHOEA	6

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