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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 021544


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NDA 021544 describes SEASONALE, which is a drug marketed by Teva Branded Pharm and is included in one NDA. It is available from two suppliers. Additional details are available on the SEASONALE profile page.

The generic ingredient in SEASONALE is ethinyl estradiol; levonorgestrel. There are twenty-six drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; levonorgestrel profile page.
Summary for 021544
Tradename:SEASONALE
Applicant:Teva Branded Pharm
Ingredient:ethinyl estradiol; levonorgestrel
Patents:0
Suppliers and Packaging for NDA: 021544
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SEASONALE ethinyl estradiol; levonorgestrel TABLET;ORAL 021544 NDA AUTHORIZED GENERIC Teva Pharmaceuticals USA, Inc. 0555-9123 0555-9123-66 3 POUCH in 1 CARTON (0555-9123-66) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK
SEASONALE ethinyl estradiol; levonorgestrel TABLET;ORAL 021544 NDA AUTHORIZED GENERIC RPK Pharmaceuticals, Inc. 53002-1779 53002-1779-1 1 KIT in 1 BLISTER PACK (53002-1779-1)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.03MG;0.15MG
Approval Date:Sep 5, 2003TE:ABRLD:Yes

Expired US Patents for NDA 021544

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Teva Branded Pharm SEASONALE ethinyl estradiol; levonorgestrel TABLET;ORAL 021544-001 Sep 5, 2003 ⤷  Try a Trial ⤷  Try a Trial
Teva Branded Pharm SEASONALE ethinyl estradiol; levonorgestrel TABLET;ORAL 021544-001 Sep 5, 2003 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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