MedPath
FDA Approval

Twirla

November 13, 2023

HUMAN PRESCRIPTION DRUG LABEL

Levonorgestrel(2.60 mg in 1 1)
Ethinylestradiol(2.30 mg in 1 1)

Products (1)

Twirla

71671-100

NDA204017

NDA (C73594)

TRANSDERMAL

September 11, 2020

Code: 5W7SIA7YZWClass: ACTIBQuantity: 2.60 mg in 1 1
Code: 423D2T571UClass: ACTIBQuantity: 2.30 mg in 1 1
ETHYL LACTATEInactive
Code: F3P750VW8IClass: IACT
DIMETHYL SULFOXIDEInactive
Code: YOW8V9698HClass: IACT
LAURYL LACTATEInactive
Code: G5SU0BFK7OClass: IACT
POLYISOBUTYLENE (55000 MW)Inactive
Code: TQ77WR8A02Class: IACT
CAPRIC ACIDInactive
Code: 4G9EDB6V73Class: IACT
POLYISOBUTYLENE (1100000 MW)Inactive
Code: FLT10CH37XClass: IACT
NITROGENInactive
Code: N762921K75Class: IACT
POLYBUTENE (1400 MW)Inactive
Code: 1NA5AO9GH7Class: IACT
COPOVIDONE K25-31Inactive
Code: D9C330MD8BClass: IACT
HEPTANEInactive
Code: 456148SDMJClass: IACT
CROSPOVIDONE (12 MPA.S AT 5%)Inactive
Code: 40UAA97IT9Class: IACT
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