Drugs@FDA: FDA Approved Drug Products
Abbreviated New Drug Application (ANDA): 200383
Company: NAARI PTE LTD
Company: NAARI PTE LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NORGESTIMATE AND ETHINYL ESTRADIOL | ETHINYL ESTRADIOL; NORGESTIMATE | 0.035MG;0.035MG;0.035MG;0.18MG;0.215MG;0.25MG | TABLET;ORAL-28 | 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 |
|---|---|---|---|---|---|---|---|
| 04/07/2015 | ORIG-1 | Approval | Not Applicable |
Label is not available on this site. |
NORGESTIMATE AND ETHINYL ESTRADIOL
TABLET;ORAL-28; 0.035MG;0.035MG;0.035MG;0.18MG;0.215MG;0.25MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| NORGESTIMATE AND ETHINYL ESTRADIOL | ETHINYL ESTRADIOL; NORGESTIMATE | 0.035MG;0.035MG;0.035MG;0.18MG;0.215MG;0.25MG | TABLET;ORAL-28 | Prescription | No | AB | 200383 | NAARI PTE LTD |
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