Activella

Product NDC

60846-201

11-digit product format

608460201

Labeler code

60846

Product ID

60846-201_a5109fb8-c0d8-4416-a795-3381b3831109

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

estradiol and norethindrone acetate

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

Gemini Laboratories, LLC

Application

NDA020907

Marketing category

NDA

Marketing start

2016-05-12

Marketing end

2019-08-31

Substance

ESTRADIOL; NORETHINDRONE ACETATE

Active strength

1 mg/1; mg/1

Pharmacologic classes

Estradiol Congeners [CS],Estrogen [EPC],Estrogen Receptor Agonists [MoA],Progesterone Congeners [CS],Progestin [EPC]

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record