Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 216796
Company: AUROBINDO PHARMA
Company: AUROBINDO PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
EMZAHH | NORETHINDRONE | 0.35MG | TABLET;ORAL-28 | Prescription | AB2 | 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 |
---|---|---|---|---|---|---|---|
01/06/2023 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
EMZAHH
TABLET;ORAL-28; 0.35MG
TE Code = AB2
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
EMZAHH | NORETHINDRONE | 0.35MG | TABLET;ORAL-28 | Prescription | No | AB2 | 216796 | AUROBINDO PHARMA |
ERRIN | NORETHINDRONE | 0.35MG | TABLET;ORAL-28 | Prescription | No | AB2 | 076225 | DR REDDYS LABS SA |
JENCYCLA | NORETHINDRONE | 0.35MG | TABLET;ORAL-28 | Prescription | No | AB2 | 091323 | LUPIN LTD |
NORETHINDRONE | NORETHINDRONE | 0.35MG | TABLET;ORAL-28 | Prescription | No | AB2 | 091209 | GLENMARK PHARMS LTD |
NORETHINDRONE | NORETHINDRONE | 0.35MG | TABLET;ORAL-28 | Prescription | No | AB2 | 200980 | MYLAN LABS LTD |
NORETHINDRONE | NORETHINDRONE | 0.35MG | TABLET;ORAL-28 | Prescription | No | AB2 | 200961 | NOVAST LABS |