Application 200910
- Type
- ANDA
- Sponsor
- MYLAN TECHNOLOGIES
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | XULANE | ETHINYL ESTRADIOL; NORELGESTROMIN | FILM, EXTENDED RELEASE;TRANSDERMAL | 0.035MG/24HR;0.15MG/24HR | No | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0378-3340 | XULANE | norelgestromin and ethinyl estradiol | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-3340 | XULANE | norelgestromin and ethinyl estradiol | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-3340 | XULANE | norelgestromin and ethinyl estradiol | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-3340 | XULANE | norelgestromin and ethinyl estradiol | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-3340 | XULANE | norelgestromin and ethinyl estradiol | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-3340 | XULANE | norelgestromin and ethinyl estradiol | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-3340 | XULANE | norelgestromin and ethinyl estradiol | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-3340 | XULANE | norelgestromin and ethinyl estradiol | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 50090-1683 | XULANE | norelgestromin and ethinyl estradiol | A-S Medication Solutions | ANDA | Current |
| 50090-1683 | XULANE | norelgestromin and ethinyl estradiol | A-S Medication Solutions | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 48853 | ORIG | 2017-06-28 |