Abbreviated New Drug Applications and 505(b)(2) Applications
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 |
| Reference Listed Drug | ANDA Holder | Generic Drug Name | ANDA Applicant(s) |
Indication | Launch Date |
|---|---|---|---|---|---|
| Astepro Allergy | Bayer | azelastine | Amneal | Used for the temporary relief of nasal congestion, runny nose, sneezing and itchy nose due to hay fever or other upper respiratory allergies in adults and children 6 years of age and older | 7/18/2022 |
| Astepro Allergy | Bayer | azelastine | Apotex | Used for the temporary relief of nasal congestion, runny nose, sneezing and itchy nose due to hay fever or other upper respiratory allergies in adults and children 6 years of age and older | 7/18/2022 |
| Astepro Allergy | Bayer | azelastine | Aurobindo | Used for the temporary relief of nasal congestion, runny nose, sneezing and itchy nose due to hay fever or other upper respiratory allergies in adults and children 6 years of age and older | 7/18/2022 |
| Allegra D 24 Hr | Sanofi | fexofenadine / pseudoephedrine | Dr. Reddy's Labs | Used to treat the symptoms of sneezing, runny or stuffy nose, itchy or watery eyes, hives, skin rash, itching, and other symptoms of allergies and the common cold (Seasonal Allergic Rhinitis with Nasal Congestion) | 7/22/2022 |
| Prilosec | AstraZeneca | ompeprazole | Apotex | Used for short-term treatment (4 to 8 weeks) of active duodenal ulcer or active benign gastric ulcer in adults | 8/10/2022 |
| Sectral | Promius | acebutolol | ANI | Used to manage hypertension in adults | 8/3/2022 |
| Clindagel | Bausch | clindamycin | Amneal | Used for topical application in the treatment of acne vulgaris | 8/11/2022 |
| Vasostrict | Endo / Par | vasopressin | Amneal | Used to increase blood pressure in adults with vasodilatory shock (e.g., post-cardiotomy or sepsis) who remain hypotensive despite fluids and catecholamines | 8/11/2022 |
| Vasostrict | Endo / Par | vasopressin | Aurobindo | Used to increase blood pressure in adults with vasodilatory shock (e.g., post-cardiotomy or sepsis) who remain hypotensive despite fluids and catecholamines | 8/16/2022 |
| Desyrel | Angelini | trazodone | Apotex | Used to treat major depressive disorder (MDD) in adults | 8/25/2022 |
| Ryaltirs | Hikma | olopatadine / mometasone | Hikma | Used to treat moderate to severe nasal symptoms associated with allergic rhinitis | 8/30/2022 |
| Revlimid | Celgene | lenalidomide | Lotus | Used to treat adult patients with multiple myeloma (MM) | 9/5/2022 |
| Revlimid | Celgene | lenalidomide | Dr. Reddy's | Used to treat adult patients with multiple myeloma (MM) | 9/7/2022 |
| Suprep Bowel Prep Kit | Braintree | sodium sulfate / potassium sulfate / magnesium sulfate | Lupin | Used to cleanse the colon as a preparation for colonoscopy in adult and pediatric patients 12 years of age and older | 9/9/2022 |
| Protopic | Astellas | tacrolimus | Teva | Used for short term and intermittent long term therapy in the treatment of patients with moderate to severe atopic dermatitis |
9/9/2022 |
| Tazorac | AbbVie | tazarotene | Cosette | Used for topical treatment of stable plaque psoriasis | 9/15/2022 |
| Faslodex | AstraZeneca | fulvestrant | Hikma | Used to treat HR-positive, HER2-negative advanced or metastatic breast cancer in combination with palbociclib in women with disease progression after endocrine therapy | 9/20/2022 |
| Velcade | Sanofi | bortezomib | Hikma | Used to treat patients with mantle cell lymphoma | 9/20/2022 |
| Revlimid | Celgene | lenalidomide | Zydus | Used to treat adult patients with multiple myeloma (MM) | 9/20/2022 |
| Samsca | Otsuka | tolvaptan | Camber / Hetero | Used to treat clinically significant hypervolemic and euvolemic hyponatremia | 9/23/2022 |
| Vesicare | Astellas | solifenacin | Camber / Hetero | Used to treat overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency | 9/28/2022 |
| Revatio | Mylan | sildenafil | Lupin | Used to treat pulmonary arterial hypertension (WHO Group I) in adults to improve exercise ability and delay clinical worsening | 9/29/2022 |
