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Details for New Drug Application (NDA): 200910
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NDA 200910 describes XULANE, which is a drug marketed by Mylan Technologies and is included in one NDA. It is available from one supplier. Additional details are available on the XULANE profile page.
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.
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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