Details for New Drug Application (NDA): 209548
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NDA 209548 describes LO-MALMOREDE, which is a drug marketed by Novast Labs and is included in one NDA. It is available from two suppliers. Additional details are available on the LO-MALMOREDE profile page.
The generic ingredient in LO-MALMOREDE is ethinyl estradiol; ethynodiol diacetate. There are twenty-six drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; ethynodiol diacetate profile page.
The generic ingredient in LO-MALMOREDE is ethinyl estradiol; ethynodiol diacetate. There are twenty-six drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; ethynodiol diacetate profile page.
Summary for 209548
| Tradename: | LO-MALMOREDE |
| Applicant: | Novast Labs |
| Ingredient: | ethinyl estradiol; ethynodiol diacetate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 209548
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LO-MALMOREDE | ethinyl estradiol; ethynodiol diacetate | TABLET;ORAL-28 | 209548 | ANDA | Mayne Pharma Inc. | 51862-894 | 51862-894-01 | 1 BLISTER PACK in 1 PACKET (51862-894-01) / 1 KIT in 1 BLISTER PACK |
| LO-MALMOREDE | ethinyl estradiol; ethynodiol diacetate | TABLET;ORAL-28 | 209548 | ANDA | Mayne Pharma Inc. | 51862-894 | 51862-894-03 | 3 BLISTER PACK in 1 CARTON (51862-894-03) / 1 KIT in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL-28 | Strength | 0.035MG;1MG | ||||
| Approval Date: | Feb 11, 2019 | TE: | AB | RLD: | No | ||||
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