Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 204305
Company: TEVA PHARMS USA INC
Company: TEVA PHARMS USA INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ETHINYL ESTRADIOL; ETONOGESTREL | ETHINYL ESTRADIOL; ETONOGESTREL | 0.015MG/24HR;0.12MG/24HR | RING;VAGINAL | Prescription | AB | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
01/13/2021 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/05/2024 | SUPPL-7 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
ETHINYL ESTRADIOL; ETONOGESTREL
RING;VAGINAL; 0.015MG/24HR;0.12MG/24HR
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ELURYNG | ETHINYL ESTRADIOL; ETONOGESTREL | 0.015MG/24HR;0.12MG/24HR | RING;VAGINAL | Prescription | No | AB | 210830 | AMNEAL |
ENILLORING | ETHINYL ESTRADIOL; ETONOGESTREL | 0.015MG/24HR;0.12MG/24HR | RING;VAGINAL | Prescription | No | AB | 211157 | XIROMED |
ETHINYL ESTRADIOL; ETONOGESTREL | ETHINYL ESTRADIOL; ETONOGESTREL | 0.015MG/24HR;0.12MG/24HR | RING;VAGINAL | Prescription | No | AB | 204305 | TEVA PHARMS USA INC |
HALOETTE | ETHINYL ESTRADIOL; ETONOGESTREL | 0.015MG/24HR;0.12MG/24HR | RING;VAGINAL | Prescription | No | AB | 211328 | DR REDDYS LABS SA |
NUVARING | ETHINYL ESTRADIOL; ETONOGESTREL | 0.015MG/24HR;0.12MG/24HR | RING;VAGINAL | Prescription | Yes | AB | 021187 | ORGANON USA ORGANON |