Details for New Drug Application (NDA): 207054
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The generic ingredient in NYLIA 7/7/7 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 207054
Tradename: | NYLIA 7/7/7 |
Applicant: | Aurobindo Pharma |
Ingredient: | ethinyl estradiol; norethindrone |
Patents: | 0 |
Suppliers and Packaging for NDA: 207054
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
NYLIA 7/7/7 | ethinyl estradiol; norethindrone | TABLET;ORAL-28 | 207054 | ANDA | A-S Medication Solutions | 50090-6321 | 50090-6321-0 | 1 BLISTER PACK in 1 BOX (50090-6321-0) / 1 KIT in 1 BLISTER PACK |
NYLIA 7/7/7 | ethinyl estradiol; norethindrone | TABLET;ORAL-28 | 207054 | ANDA | Aurobindo Pharma Limited | 65862-897 | 65862-897-88 | 3 POUCH in 1 CARTON (65862-897-88) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL-28 | Strength | 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG | ||||
Approval Date: | Oct 21, 2016 | TE: | AB | RLD: | No |
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