Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077681
Company: DR REDDYS LABS SA
Company: DR REDDYS LABS SA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LEVONORGESTREL AND ETHINYL ESTRADIOL | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.02MG;0.1MG | TABLET;ORAL-28 | Prescription | AB2 | No | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
05/31/2006 | ORIG-1 | Approval |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/077681Orig1s000Lbl.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/29/2022 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
||
09/14/2017 | SUPPL-12 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
05/31/2006 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/077681Orig1s000Lbl.pdf |
LEVONORGESTREL AND ETHINYL ESTRADIOL
TABLET;ORAL-28; 0.02MG;0.1MG
TE Code = AB2
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
LESSINA-28 | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.02MG;0.1MG | TABLET;ORAL-28 | Prescription | No | AB2 | 075803 | BARR |
LEVONORGESTREL AND ETHINYL ESTRADIOL | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.02MG;0.1MG | TABLET;ORAL-28 | Prescription | No | AB2 | 077681 | DR REDDYS LABS SA |