Drugs@FDA: FDA Approved Drug Products
Abbreviated New Drug Application (ANDA): 209548
Company: NOVAST LABS
Company: NOVAST LABS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LO-MALMOREDE | ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE | 0.035MG;1MG | 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 |
|---|---|---|---|---|---|---|---|
| 02/11/2019 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
LO-MALMOREDE
TABLET;ORAL-28; 0.035MG;1MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL | ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE | 0.035MG;1MG | TABLET;ORAL-28 | Prescription | No | AB | 204703 | MYLAN LABS LTD |
| KELNOR | ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE | 0.035MG;1MG | TABLET;ORAL-28 | Prescription | No | AB | 076785 | BARR |
| LO-MALMOREDE | ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE | 0.035MG;1MG | TABLET;ORAL-28 | Prescription | No | AB | 209548 | NOVAST LABS |
| ZOVIA 1/35E-28 | ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE | 0.035MG;1MG | TABLET;ORAL-28 | Prescription | No | AB | 072721 | MAYNE PHARMA |
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English