Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 209632
Company: AUROBINDO PHARMA LTD
Company: AUROBINDO PHARMA LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LO-ZUMANDIMINE | DROSPIRENONE; ETHINYL ESTRADIOL | 3MG;0.02MG | 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 |
---|---|---|---|---|---|---|---|
02/27/2018 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
LO-ZUMANDIMINE
TABLET;ORAL; 3MG;0.02MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DROSPIRENONE AND ETHINYL ESTRADIOL | DROSPIRENONE; ETHINYL ESTRADIOL | 3MG;0.02MG | TABLET;ORAL | Prescription | No | AB | 203291 | ALLIED |
DROSPIRENONE AND ETHINYL ESTRADIOL | DROSPIRENONE; ETHINYL ESTRADIOL | 3MG;0.02MG | TABLET;ORAL | Prescription | No | AB | 078515 | BARR |
DROSPIRENONE AND ETHINYL ESTRADIOL | DROSPIRENONE; ETHINYL ESTRADIOL | 3MG;0.02MG | TABLET;ORAL | Prescription | No | AB | 204296 | GLENMARK PHARMS LTD |
DROSPIRENONE AND ETHINYL ESTRADIOL | DROSPIRENONE; ETHINYL ESTRADIOL | 3MG;0.02MG | TABLET;ORAL | Prescription | No | AB | 211944 | HETERO LABS LTD |
DROSPIRENONE AND ETHINYL ESTRADIOL | DROSPIRENONE; ETHINYL ESTRADIOL | 3MG;0.02MG | TABLET;ORAL | Prescription | No | AB | 209423 | JUBILANT CADISTA |
DROSPIRENONE AND ETHINYL ESTRADIOL | DROSPIRENONE; ETHINYL ESTRADIOL | 3MG;0.02MG | TABLET;ORAL | Prescription | No | AB | 202594 | MYLAN LABS LTD |
DROSPIRENONE AND ETHINYL ESTRADIOL | DROSPIRENONE; ETHINYL ESTRADIOL | 3MG;0.02MG | TABLET;ORAL | Prescription | No | AB | 078833 | WATSON LABS |
KYRA | DROSPIRENONE; ETHINYL ESTRADIOL | 3MG;0.02MG | TABLET;ORAL | Prescription | No | AB | 202318 | SUN PHARM |
LO-ZUMANDIMINE | DROSPIRENONE; ETHINYL ESTRADIOL | 3MG;0.02MG | TABLET;ORAL | Prescription | No | AB | 209632 | AUROBINDO PHARMA LTD |
LORYNA | DROSPIRENONE; ETHINYL ESTRADIOL | 3MG;0.02MG | TABLET;ORAL | Prescription | No | AB | 079221 | XIROMED |
MELAMISA | DROSPIRENONE; ETHINYL ESTRADIOL | 3MG;0.02MG | TABLET;ORAL | Prescription | No | AB | 202016 | NOVAST LABS |
NIKKI | DROSPIRENONE; ETHINYL ESTRADIOL | 3MG;0.02MG | TABLET;ORAL | Prescription | No | AB | 201661 | LUPIN LTD |
YAZ | DROSPIRENONE; ETHINYL ESTRADIOL | 3MG;0.02MG | TABLET;ORAL | Prescription | Yes | AB | 021676 | BAYER HLTHCARE |
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