Details for New Drug Application (NDA): 203163
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NDA 203163 describes ASHLYNA, which is a drug marketed by Glenmark Pharms Ltd and is included in one NDA. It is available from two suppliers. Additional details are available on the ASHLYNA profile page.
The generic ingredient in ASHLYNA is ethinyl estradiol; levonorgestrel. There are twenty-six drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; levonorgestrel profile page.
The generic ingredient in ASHLYNA is ethinyl estradiol; levonorgestrel. There are twenty-six drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; levonorgestrel profile page.
Summary for 203163
| Tradename: | ASHLYNA |
| Applicant: | Glenmark Pharms Ltd |
| Ingredient: | ethinyl estradiol; levonorgestrel |
| Patents: | 0 |
Suppliers and Packaging for NDA: 203163
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ASHLYNA | ethinyl estradiol; levonorgestrel | TABLET;ORAL | 203163 | ANDA | A-S Medication Solutions | 50090-2097 | 50090-2097-0 | 1 KIT in 1 KIT (50090-2097-0) |
| ASHLYNA | ethinyl estradiol; levonorgestrel | TABLET;ORAL | 203163 | ANDA | Glenmark Pharmaceuticals Inc., USA | 68462-646 | 68462-646-93 | 2 POUCH in 1 CARTON (68462-646-93) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK (68462-646-91) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.03MG,0.01MG;0.15MG,N/A | ||||
| Approval Date: | Feb 23, 2015 | TE: | AB | RLD: | No | ||||
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