Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 091692
Company: NOVAST LABS
Company: NOVAST LABS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DOLISHALE | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.02MG;0.09MG | TABLET;ORAL | 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 |
---|---|---|---|---|---|---|---|
10/22/2020 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/29/2022 | SUPPL-3 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
DOLISHALE
TABLET;ORAL; 0.02MG;0.09MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DOLISHALE | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.02MG;0.09MG | TABLET;ORAL | Prescription | No | AB | 091692 | NOVAST LABS |
LEVONORGESTREL AND ETHINYL ESTRADIOL | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.02MG;0.09MG | TABLET;ORAL | Prescription | No | AB | 202791 | GLENMARK PHARMS LTD |
LEVONORGESTREL AND ETHINYL ESTRADIOL | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.02MG;0.09MG | TABLET;ORAL | Prescription | No | AB | 079218 | WATSON LABS |