Details for New Drug Application (NDA): 201512
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NDA 201512 describes PIRMELLA 1/35, which is a drug marketed by Lupin Ltd and is included in one NDA. It is available from one supplier. Additional details are available on the PIRMELLA 1/35 profile page.
The generic ingredient in PIRMELLA 1/35 is ethinyl estradiol; norethindrone. There are twenty-six drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone profile page.
The generic ingredient in PIRMELLA 1/35 is ethinyl estradiol; norethindrone. There are twenty-six drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone profile page.
Summary for 201512
| Tradename: | PIRMELLA 1/35 |
| Applicant: | Lupin Ltd |
| Ingredient: | ethinyl estradiol; norethindrone |
| Patents: | 0 |
Suppliers and Packaging for NDA: 201512
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PIRMELLA 1/35 | ethinyl estradiol; norethindrone | TABLET;ORAL-28 | 201512 | ANDA | Lupin Pharmaceuticals, Inc. | 68180-893 | 68180-893-73 | 3 BLISTER PACK in 1 CARTON (68180-893-73) / 1 KIT in 1 BLISTER PACK (68180-893-71) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL-28 | Strength | 0.035MG;1MG | ||||
| Approval Date: | Apr 24, 2013 | TE: | RLD: | No | |||||
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