Details for New Drug Application (NDA): 208612
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The generic ingredient in BALCOLTRA is ethinyl estradiol; levonorgestrel. There are twenty-six drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; levonorgestrel profile page.
Summary for 208612
Tradename: | BALCOLTRA |
Applicant: | Avion Pharms |
Ingredient: | ethinyl estradiol; levonorgestrel |
Patents: | 1 |
Suppliers and Packaging for NDA: 208612
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
BALCOLTRA | ethinyl estradiol; levonorgestrel | TABLET;ORAL | 208612 | NDA | Acella Pharmaceuticals | 42192-623 | 42192-623-03 | 3 BLISTER PACK in 1 CARTON (42192-623-03) / 1 KIT in 1 BLISTER PACK |
BALCOLTRA | ethinyl estradiol; levonorgestrel | TABLET;ORAL | 208612 | NDA | Acella Pharmaceuticals | 42192-623 | 42192-623-28 | 1 BLISTER PACK in 1 CARTON (42192-623-28) / 1 KIT in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.02MG;0.1MG | ||||
Approval Date: | Jan 9, 2018 | TE: | AB3 | RLD: | Yes | ||||
Patent: | ⤷ Sign Up | Patent Expiration: | Jun 1, 2027 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
Patented Use: | ADMINISTRATION OF FERROUS BISGLYCINATE TABLETS |
Expired US Patents for NDA 208612
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Avion Pharms | BALCOLTRA | ethinyl estradiol; levonorgestrel | TABLET;ORAL | 208612-001 | Jan 9, 2018 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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