Abbreviated New Drug Applications and 505(b)(2) Applications
This chart tracks the date, drug, reference-listed company, applicant, and indications of publicly available drug launches resulting from Abbreviated New Drug Applications and 505(b)(2) Applications.
Reference Listed Drug | ANDA Holder | Generic Drug Name | ANDA Applicant(s) | Indication | Launch Date |
Yaz | Bayer HealthCare Pharmaceuticals Inc.'s | Vestura(TM) (3 mg drospirenone and 0.02 mg ethinyl estradiol) | Watson Pharmaceuticals | prevention of pregnancy and for the treatment of moderate acne in women | Jan. 18, 2012 |
Zanaflex | Watson Pharmaceuticals | tizanidine hydrochloride capsules | Acorda Therapeutics, | short-acting drug indicated for the management of spasticity. | Feb. 6, 2012 |
Zanaflex | Acorda Therapeutics | tizanidinehydrochloride | Apotex | Multiple sclerosis skeletal muscle relaxants | Feb. 9, 2012 |
Lexapro | Forest Laboratory | Escitalopram Tablets USP, 5 mg, 10 mg and 20 mg | Mylan Pharmaceuticals Inc. | depression and generalized anxiety disorder treatment | Feb. 29, 2012 |
Geodon | Pfizer Inc.'s | ziprasidone | Dr. Reddy's Laboratories | antipsychotic drug | Mar. 2, 2012 |
Prometrium | Abbott Laboratories | Progesterone Capsules, 100 & 200 mg | Teva Pharmaceutical Industries Ltd. | secondary amenorrhea due to a decrease in progesterone as well as in conjunction with estrogen-containing medications in postmenopausal women with a uterus. | Mar. 2, 2012 |
Prometrium | Abbott Laboratories | Progesterone Capsules, 100 & 200 mg | Watson Pharmaceuticals | secondary amenorrhea due to a decrease in progesterone as well as in conjunction with estrogen-containing medications in postmenopausal women with a uterus. | Mar. 2, 2012 |
Geodon | Pfizer Inc.'s | ziprasidone | Lupin Pharmaceuticals | antipsychotic drug | Mar. 3, 2012 |
Lexapro | Forest Laboratory | Escitalopram Oxalate Tablets | Teva Pharmaceutical Industries Ltd. | depression and generalized anxiety disorder treatment | Mar. 14, 2012 |
Lexapro | Forest Laboratory | Escitalopram Oxalate Tablets | Amneal Pharmaceuticals | depression and generalized anxiety disorder treatment | Mar. 15, 2012 |
Seroquel | AstraZeneca | quetiapine fumarate tablets | Teva Pharmaceutical Industries Ltd. | antidepressants in major depressive disorder and acute depressive episodes in bipolar disorder | Mar. 28, 2012 |
Seroquel | AstraZeneca | quetiapine fumarate tablets | Mylan Pharmaceuticals Inc. | antidepressants in major depressive disorder and acute depressive episodes in bipolar disorder | Mar. 28, 2012 |