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Details for New Drug Application (NDA): 200910
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The generic ingredient in XULANE is ethinyl estradiol; norelgestromin. There are twenty-six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ethinyl estradiol; norelgestromin profile page.
Summary for 200910
Tradename: | XULANE |
Applicant: | Mylan Technologies |
Ingredient: | ethinyl estradiol; norelgestromin |
Patents: | 0 |
Pharmacology for NDA: 200910
Mechanism of Action | Estrogen Receptor Agonists |
Suppliers and Packaging for NDA: 200910
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
XULANE | ethinyl estradiol; norelgestromin | FILM, EXTENDED RELEASE;TRANSDERMAL | 200910 | ANDA | Mylan Pharmaceuticals Inc. | 0378-3340 | 0378-3340-32 | 1 POUCH in 1 CARTON (0378-3340-32) > 1 PATCH in 1 POUCH (0378-3340-17) > 7 d in 1 PATCH |
XULANE | ethinyl estradiol; norelgestromin | FILM, EXTENDED RELEASE;TRANSDERMAL | 200910 | ANDA | Mylan Pharmaceuticals Inc. | 0378-3340 | 0378-3340-53 | 3 POUCH in 1 CARTON (0378-3340-53) > 1 PATCH in 1 POUCH (0378-3340-16) > 7 d in 1 PATCH |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | FILM, EXTENDED RELEASE;TRANSDERMAL | Strength | 0.035MG/24HR;0.15MG/24HR | ||||
Approval Date: | Apr 16, 2014 | TE: | RLD: | No |
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