February 15, 2024
February 15, 2024
- Drug Trials Snapshots: BIMZELX
- Drug Trials Snapshots: BEYFORTUS
- FDA Drug Shortages
- Mepivacaine Hydrochloride Injection (Updated – Resolved)
- Upcoming Product-Specific Guidances for Generic Drug Product Development (Updated)
This report displays final approvals and tentative approvals of original and supplemental applications for the two days beginning on the earliest date listed below. Some approvals may be added to the Drugs@FDA database after this time span. For comprehensive approval reports, please use the monthly “All Approvals” report on Drugs@FDA.
February 15, 2024
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Premarin NDA #004782 | Estrogens, Conjugated | Tablet; Oral | SUPPL-181 | Wyeth Pharms | Labeling | Approved |
| Delestrogen NDA #009402 | Estradiol Valerate | Injectable; Injection | SUPPL-63 | Par Sterile Products | Labeling | Approved |
| Premarin NDA #010402 | Estrogens, Conjugated | Injectable; Injection | SUPPL-73 | Wyeth Pharms | Labeling | Approved |
| Provera NDA #011839 | Medroxyprogesterone Acetate | Tablet; Oral | SUPPL-83 | Pfizer | Labeling | Approved |
| Prometrium NDA #019781 | Progesterone | Capsule; Oral | SUPPL-25 | Virtus | Labeling | Approved |
| Premarin NDA #020216 | Estrogens, Conjugated | Cream; Topical, Vaginal | SUPPL-91 | Wyeth Pharms | Labeling | Approved |
| Vivelle NDA #020323 | Estradiol | System; Transdermal | SUPPL-38 | Sandoz | Labeling | Approved |
| Climara NDA #020375 | Estradiol | Film, Extended Release; Transdermal | SUPPL-49 | Bayer Hlthcare | Labeling | Approved |
| Climara NDA #020375 | Estradiol | Film, Extended Release; Transdermal | SUPPL-50 | Bayer Hlthcare | Labeling | Approved |
| Menostar NDA #020375 | Estradiol | Film, Extended Release; Transdermal | SUPPL-49 | Bayer Hlthcare | Labeling | Approved |
| Menostar NDA #020375 | Estradiol | Film, Extended Release; Transdermal | SUPPL-50 | Bayer Hlthcare | Labeling | Approved |
| Estring NDA #020472 | Estradiol | Insert, Extended Release; Vaginal | SUPPL-20 | Pfizer | Labeling | Approved |
| Premphase 14/14 NDA #020527 | Estrogens, Conjugated; Medroxyprogesterone Acetate | Tablet; Oral-28 | SUPPL-68 | Wyeth Pharms | Labeling | Approved |
| Prempro NDA #020527 | Estrogens, Conjugated; Medroxyprogesterone Acetate | Tablet; Oral-28 | SUPPL-68 | Wyeth Pharms | Labeling | Approved |
| Estradiol NDA #020538 | Estradiol | Film, Extended Release; Transdermal | SUPPL-43 | Sandoz | Labeling | Approved |
| Vivelle-Dot NDA #020538 | Estradiol | System; Transdermal | SUPPL-43 | Sandoz | Labeling | Approved |
| Alora NDA #020655 | Estradiol | Film, Extended Release; Transdermal | SUPPL-23 | Abbvie | Labeling | Approved |
| Combipatch NDA #020870 | Estradiol; Norethindrone Acetate | Film, Extended Release; Transdermal | SUPPL-33 | Noven Pharms Inc | Labeling | Approved |
| Activella NDA #020907 | Estradiol; Norethindrone Acetate | Tablet; Oral | SUPPL-30 | Amneal | Labeling | Approved |
| Vagifem NDA #020908 | Estradiol | Tablet; Vaginal | SUPPL-30 | Novo Nordisk Inc | Labeling | Approved |
| Cenestin NDA #020992 | Estrogens, Conjugated Synthetic A | Tablet; Oral | SUPPL-41 | Aspen | Labeling | Approved |
| Prefest NDA #021040 | Estradiol; Norgestimate | Tablet; Oral | SUPPL-15 | Teva Womens | Labeling | Approved |
| Prefest NDA #021040 | Estradiol; Norgestimate | Tablet; Oral | SUPPL-15 | Teva Womens | Labeling | Approved |
| Estrogel NDA #021166 | Estradiol | Gel, Metered; Transdermal | SUPPL-19 | Ascend Theraps Us | Labeling | Approved |
| Estrogel NDA #021166 | Estradiol | Gel, Metered; Transdermal | SUPPL-19 | Ascend Theraps Us | Labeling | Approved |
| Estrogel NDA #021166 | Estradiol | Gel; Topical | SUPPL-19 | Ascend Theraps Us | Labeling | Approved |
| Estrogel NDA #021166 | Estradiol | Gel; Topical | SUPPL-19 | Ascend Theraps Us | Labeling | Approved |
| Climara Pro NDA #021258 | Estradiol; Levonorgestrel | Film, Extended Release; Transdermal | SUPPL-15 | Bayer Hlthcare | Labeling | Approved |
| Angeliq NDA #021355 | Drospirenone; Estradiol | Tablet; Oral | SUPPL-12 | Bayer Hlthcare | Labeling | Approved |
| Femring NDA #021367 | Estradiol Acetate | Insert, Extended Release; Vaginal | SUPPL-21 | Millicent | Labeling | Approved |
| Estrasorb NDA #021371 | Estradiol Hemihydrate | Emulsion; Topical | SUPPL-10 | Exeltis Usa Inc | Labeling | Approved |
| Enjuvia NDA #021443 | Estrogens, Conjugated Synthetic B | Tablet; Oral | SUPPL-13 | Aspen | Labeling | Approved |
| Elestrin NDA #021813 | Estradiol | Gel, Metered; Transdermal | SUPPL-14 | Mylan Speciality Lp | Labeling | Approved |
| Evamist NDA #022014 | Estradiol | Spray; Transdermal | SUPPL-15 | Padagis Us | Labeling | Approved |
| Divigel NDA #022038 | Estradiol | Gel; Transdermal | SUPPL-12 | Vertical Pharms | Labeling | Approved |
| Rifampin ANDA #065421 | Rifampin | Injectable; Injection | SUPPL-18 | Mylan Labs Ltd | Labeling | Approved |
| Rifampin ANDA #065421 | Rifampin | Injectable; Injection | SUPPL-19 | Mylan Labs Ltd | Labeling | Approved |
| Rifampin ANDA #065421 | Rifampin | Injectable; Injection | SUPPL-21 | Mylan Labs Ltd | Labeling | Approved |
| Rifampin ANDA #065421 | Rifampin | Injectable; Injection | SUPPL-23 | Mylan Labs Ltd | Labeling | Approved |
| Rifampin ANDA #065421 | Rifampin | Injectable; Injection | SUPPL-26 | Mylan Labs Ltd | Labeling | Approved |
| Lucentis BLA #125156 | Ranibizumab | Injectable; Injection | SUPPL-128 | Genentech | Labeling | Approved |
| Osphena NDA #203505 | Ospemifene | Tablet; Oral | SUPPL-22 | Duchesnay | Labeling | Approved |
| Minivelle NDA #203752 | Estradiol | Film, Extended Release; Transdermal | SUPPL-22 | Noven | Labeling | Approved |
| Imvexxy NDA #208564 | Estradiol | Insert; Vaginal | SUPPL-6 | Mayne Pharma | Labeling | Approved |
| Bijuva NDA #210132 | Estradiol; Progesterone | Capsule; Oral | SUPPL-11 | Mayne Pharma | Labeling | Approved |
| Enhertu BLA #761139 | Fam-Trastuzumab Deruxtecan-Nxki | Injectable; Injection | SUPPL-26 | Daiichi Sankyo | Efficacy | Approved |
Showing 1 to 46 of 46 entries
Source: FDA