Drugs@FDA: FDA-Approved Drugs
Recent New and Generic Drug Approvals
This report displays final approvals and tentative approvals of original and supplemental applications for the two weeks beginning on the earliest date listed below. Some approvals may be added to the Drugs@FDA database after this timespan. For comprehensive approval reports, please use the monthly "All Approvals" report on Drugs@FDA.
October 8, 2026
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Breztri Aerosphere
NDA #220290 |
Budesonide, Glycopyrrolate, and Formoterol Fumarate | Inhalant; Oral | ORIG-1 | Astrazeneca Ab | Type 5 - New Formulation or New Manufacturer | Approved |
| Carbidopa and Levodopa
ANDA #075091 |
Carbidopa; Levodopa | Tablet, Extended Release; Oral | SUPPL-36 | Mylan | Labeling | Approved |
| Fenofibrate
ANDA #211080 |
Fenofibrate | Tablet; Oral | SUPPL-3 | Prinston Inc | Labeling | Approved |
| Fenofibric Acid
ANDA #200264 |
Choline Fenofibrate | Capsule, Delayed Release; Oral | SUPPL-8 | Impax Labs Inc | Labeling | Approved |
| Fenofibric Acid
ANDA #212598 |
Choline Fenofibrate | Capsule, Delayed Release; Oral | SUPPL-6 | Aurobindo Pharma Ltd | Labeling | Approved |
| Oxcarbazepine
ANDA #218278 |
Oxcarbazepine | Suspension; Oral | SUPPL-2 | Biocon Pharma | Labeling | Approved |
| Oxcarbazepine
ANDA #218278 |
Oxcarbazepine | Suspension; Oral | SUPPL-2 | Biocon Pharma | Labeling | Approved |
| Pitolisant
ANDA #218832 |
Pitolisant | Tablet | ORIG-1 | Annora Pharma Private Limited | Approved | |
| Tafluprost
ANDA #209040 |
Tafluprost | Solution/Drops; Ophthalmic | SUPPL-2 | Sandoz | Labeling | Approved |
| Tafluprost
ANDA #209051 |
Tafluprost | Solution/Drops; Ophthalmic | SUPPL-3 | Micro Labs | Labeling | Approved |
| Tafluprost
ANDA #209051 |
Tafluprost | Solution/Drops; Ophthalmic | SUPPL-3 | Micro Labs | Labeling | Approved |
| Tecentriq
BLA #761034 |
Atezolizumab | Injectable; Injection | SUPPL-65 | Genentech Inc | Efficacy | Approved |
| Tecentriq Hybreza
BLA #761347 |
Atezolizumab and Hyaluronidase-Tqjs | Injectable; Injection | SUPPL-11 | Genentech Inc | Efficacy | Approved |
| Weltruza
NDA #219007 |
Olanzapine | Suspension, Extended Release; Injectable | ORIG-1 | Teva Neuroscience Inc | Type 5 - New Formulation or New Manufacturer | Approved |
October 7, 2026
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Absorica
NDA #021951 |
Isotretinoin | Capsule; Oral | SUPPL-32 | Sun Pharm Inds Inc | REMS | Approved |
| Absorica Ld
NDA #211913 |
Isotretinoin | Capsule; Oral | SUPPL-24 | Sun Pharm | REMS | Approved |
| Amnesteem
ANDA #075945 |
Isotretinoin | Capsule; Oral | SUPPL-53 | Mylan Pharms Inc | REMS | Approved |
| Claravis
ANDA #076135 |
Isotretinoin | Capsule; Oral | SUPPL-70 | Teva Pharms Usa | REMS | Approved |
| Claravis
ANDA #076356 |
Isotretinoin | Capsule; Oral | SUPPL-64 | Teva Pharms Usa | REMS | Approved |
| Duac
NDA #050741 |
Benzoyl Peroxide; Clindamycin Phosphate | Gel; Topical | SUPPL-26 | Stiefel | Labeling | Approved |
| Fidaxomicin
ANDA #219737 |
Fidaxomicin | Tablet; Oral | ORIG-1 | Hikma Pharms | Approved | |
| Hydrochlorothiazide
ANDA #218248 |
Hydrochlorothiazide | Solution; Oral | ORIG-1 | Rubicon Research | Approved | |
| Isotretinoin
ANDA #205063 |
Isotretinoin | Capsule; Oral | SUPPL-13 | Actavis Labs Fl | REMS | Approved |
| Isotretinoin
ANDA #207792 |
Isotretinoin | Capsule; Oral | SUPPL-38 | Amneal Pharms Ny | REMS | Approved |
| Isotretinoin
ANDA #211568 |
Isotretinoin | Capsule; Oral | SUPPL-9 | Zydus Pharms | REMS | Approved |
| Isotretinoin
ANDA #212333 |
Isotretinoin | Capsule; Oral | SUPPL-20 | Upsher Smith Labs | REMS | Approved |
| Isotretinoin
ANDA #213571 |
Isotretinoin | Capsule; Oral | SUPPL-19 | Upsher Smith Labs | REMS | Approved |
| Isotretinoin
ANDA #216097 |
Isotretinoin | Capsule; Oral | SUPPL-3 | Amneal Pharms Ny | REMS | Approved |
| Isotretinoin
ANDA #216633 |
Isotretinoin | Capsule; Oral | SUPPL-4 | Zydus Pharms | REMS | Approved |
| Isotretinoin
ANDA #218194 |
Isotretinoin | Capsule; Oral | SUPPL-6 | Aurobindo Pharma | REMS | Approved |
| Isotretinoin
ANDA #220336 |
Isotretinoin | Capsule; Oral | SUPPL-1 | Aurobindo Pharma Ltd | REMS | Approved |
| Mirabegron
ANDA #219599 |
Mirabegron | Tablet, Extended Release; Oral | ORIG-1 | Creekwood Pharms | Approved | |
| Myorisan
ANDA #076485 |
Isotretinoin | Capsule; Oral | SUPPL-49 | Upsher Smith Labs | REMS | Approved |
| Tukysa
NDA #213411 |
Tucatinib | Tablet; Oral | SUPPL-10 | Seagen | Efficacy | Approved |
| Zenatane
ANDA #202099 |
Isotretinoin | Capsule; Oral | SUPPL-43 | Dr Reddys Labs Ltd | REMS | Approved |
October 6, 2026
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Lisdexamfetamine Dimesylate
ANDA #216944 |
Lisdexamfetamine Dimesylate | Capsule; Oral | SUPPL-4 | Apotex | Labeling | Approved |
| Lisdexamfetamine Dimesylate
ANDA #216944 |
Lisdexamfetamine Dimesylate | Capsule; Oral | SUPPL-5 | Apotex | Labeling | Approved |
| Lisdexamfetamine Dimesylate
ANDA #216944 |
Lisdexamfetamine Dimesylate | Capsule; Oral | SUPPL-4 | Apotex | Labeling | Approved |
| Lisdexamfetamine Dimesylate
ANDA #216944 |
Lisdexamfetamine Dimesylate | Capsule; Oral | SUPPL-5 | Apotex | Labeling | Approved |
| Proglycem
NDA #017453 |
Diazoxide | Suspension; Oral | SUPPL-25 | Teva Branded Pharm | Labeling | Approved |
| Rhapsido
NDA #218436 |
Remibrutinib | Tablet; Oral | SUPPL-1 | Novartis | Efficacy | Approved |
| Sertraline Hydrochloride
NDA #215133 |
Sertraline Hydrochloride | Capsule; Oral | SUPPL-4 | Almatica | Labeling | Approved |
| Sodium Bicarbonate
NDA #218524 |
Sodium Bicarbonate | Solution; Intravenous | SUPPL-1 | Baxter Hlthcare Corp | Labeling | Approved |
| Sodium Bicarbonate
NDA #218524 |
Sodium Bicarbonate | Solution; Intravenous | SUPPL-1 | Baxter Hlthcare Corp | Labeling | Approved |
| Solriamfetol
ANDA #218725 |
Solriamfetol | Tablet | ORIG-1 | Aurobindo Pharma Ltd | Approved | |
| Solriamfetol Hydrochloride
ANDA #218725 |
Solriamfetol Hydrochloride | Tablet; Oral | ORIG-1 | Aurobindo Pharma Ltd | Approved | |
| Sugammadex Sodium
ANDA #215701 |
Sugammadex Sodium | Solution; Intravenous | ORIG-1 | Shandong | Approved | |
| Valsartan
ANDA #204011 |
Valsartan | Tablet; Oral | SUPPL-22 | Amneal Pharms | Labeling | Approved |
| Valsartan
ANDA #204011 |
Valsartan | Tablet; Oral | SUPPL-22 | Amneal Pharms | Labeling | Approved |
| Valsartan
ANDA #204011 |
Valsartan | Tablet; Oral | SUPPL-22 | Amneal Pharms | Labeling | Approved |
October 5, 2026
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Acthar Gel
NDA #008372 |
Corticotropin | Injectable; Injection | SUPPL-88 | Mallinckrodt Ireland | Labeling | Approved |
| Acthar Gel (Autoinjector)
NDA #008372 |
Corticotropin | Injectable; Injection | SUPPL-88 | Mallinckrodt Ireland | Labeling | Approved |
| Bupropion Hydrochloride
ANDA #208652 |
Bupropion Hydrochloride | Tablet, Extended Release; Oral | SUPPL-14 | Sinotherapeutics Inc | Labeling | Approved |
| Carbamazepine
ANDA #212524 |
Carbamazepine | Tablet, Extended Release; Oral | SUPPL-2 | Torrent | Labeling | Approved |
| Carbamazepine
ANDA #213159 |
Carbamazepine | Tablet, Extended Release; Oral | SUPPL-1 | Apotex | Labeling | Approved |
| Carbamazepine
ANDA #213159 |
Carbamazepine | Tablet, Extended Release; Oral | SUPPL-1 | Apotex | Labeling | Approved |
| Cortrophin-Zinc
NDA #009854 |
Corticotropin-Zinc Hydroxide | Injectable; Injection | SUPPL-13 | Ani Pharms | Labeling | Approved |
| Dexmethylphenidate Hydrochloride
ANDA #079108 |
Dexmethylphenidate Hydrochloride | Capsule, Extended Release; Oral | SUPPL-20 | Impax Labs Inc | Labeling | Approved |
| Dexmethylphenidate Hydrochloride
ANDA #079108 |
Dexmethylphenidate Hydrochloride | Capsule, Extended Release; Oral | SUPPL-20 | Impax Labs Inc | Labeling | Approved |
| Dextroamp Saccharate, Amp Aspartate, Dextroamp Sulfate and Amp Sulfate
ANDA #214403 |
Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Capsule, Extended Release; Oral | SUPPL-5 | Lannett Co Inc | Labeling | Approved |
| Dextroamp Saccharate, Amp Aspartate, Dextroamp Sulfate and Amp Sulfate
ANDA #214403 |
Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Capsule, Extended Release; Oral | SUPPL-6 | Lannett Co Inc | Labeling | Approved |
| Dextroamp Saccharate, Amp Aspartate, Dextroamp Sulfate and Amp Sulfate
ANDA #214403 |
Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Capsule, Extended Release; Oral | SUPPL-5 | Lannett Co Inc | Labeling | Approved |
| Dextroamp Saccharate, Amp Aspartate, Dextroamp Sulfate and Amp Sulfate
ANDA #214403 |
Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Capsule, Extended Release; Oral | SUPPL-6 | Lannett Co Inc | Labeling | Approved |
| Diclofenac Sodium
ANDA #210986 |
Diclofenac Sodium | Gel; Topical | SUPPL-27 | Encube | Labeling | Approved |
| Diclofenac Sodium
ANDA #210986 |
Diclofenac Sodium | Gel; Topical | SUPPL-27 | Encube | Labeling | Approved |
| Divalproex Sodium
ANDA #218793 |
Divalproex Sodium | Capsule, Delayed Rel Pellets; Oral | SUPPL-1 | Alembic | Labeling | Approved |
| Divalproex Sodium
ANDA #218793 |
Divalproex Sodium | Capsule, Delayed Rel Pellets; Oral | SUPPL-2 | Alembic | Labeling | Approved |
| Divalproex Sodium
ANDA #218793 |
Divalproex Sodium | Capsule, Delayed Rel Pellets; Oral | SUPPL-1 | Alembic | Labeling | Approved |
| Divalproex Sodium
ANDA #218793 |
Divalproex Sodium | Capsule, Delayed Rel Pellets; Oral | SUPPL-2 | Alembic | Labeling | Approved |
| Divalproex Sodium
ANDA #218793 |
Divalproex Sodium | Capsule, Delayed Rel Pellets; Oral | SUPPL-3 | Alembic | Labeling | Approved |
| Doxepin Hydrochloride
ANDA #213796 |
Doxepin Hydrochloride | Capsule; Oral | SUPPL-1 | Adaptis | Labeling | Approved |
| Moxifloxacin Hydrochloride
ANDA #205348 |
Moxifloxacin Hydrochloride | Tablet; Oral | SUPPL-8 | Crossmedika Sa | Labeling | Approved |
| Moxifloxacin Hydrochloride
ANDA #205348 |
Moxifloxacin Hydrochloride | Tablet; Oral | SUPPL-8 | Crossmedika Sa | Labeling | Approved |
| Purified Cortrophin Gel
NDA #008975 |
Corticotropin | Injectable; Injection | SUPPL-24 | Ani Pharms | Labeling | Approved |
| Topiramate
ANDA #215663 |
Topiramate | Capsule, Extended Release; Oral | SUPPL-6 | Ajanta Pharma Ltd | Labeling | Approved |
| Topiramate
ANDA #217248 |
Topiramate | Capsule, Extended Release; Oral | SUPPL-1 | Alkem Labs Ltd | Labeling | Approved |
| Topiramate
ANDA #217248 |
Topiramate | Capsule, Extended Release; Oral | SUPPL-2 | Alkem Labs Ltd | Labeling | Approved |
| Topiramate
ANDA #217248 |
Topiramate | Capsule, Extended Release; Oral | SUPPL-1 | Alkem Labs Ltd | Labeling | Approved |
| Topiramate
ANDA #217248 |
Topiramate | Capsule, Extended Release; Oral | SUPPL-2 | Alkem Labs Ltd | Labeling | Approved |
| Topiramate
ANDA #217248 |
Topiramate | Capsule, Extended Release; Oral | SUPPL-6 | Alkem Labs Ltd | Labeling | Approved |
October 2, 2026
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Celecoxib
ANDA #213301 |
Celecoxib | Capsule; Oral | SUPPL-6 | Unichem | Labeling | Approved |
| Celecoxib
ANDA #213301 |
Celecoxib | Capsule; Oral | SUPPL-6 | Unichem | Labeling | Approved |
| Clozapine
ANDA #075417 |
Clozapine | Tablet; Oral | SUPPL-64 | Mylan | Labeling | Approved |
| Clozapine
ANDA #075417 |
Clozapine | Tablet; Oral | SUPPL-64 | Mylan | Labeling | Approved |
| Clozapine
ANDA #075417 |
Clozapine | Tablet; Oral | SUPPL-61 | Mylan | Labeling | Approved |
| Clozapine
ANDA #075417 |
Clozapine | Tablet; Oral | SUPPL-62 | Mylan | Labeling | Approved |
| Clozapine
ANDA #075417 |
Clozapine | Tablet; Oral | SUPPL-64 | Mylan | Labeling | Approved |
| Clozapine
ANDA #202873 |
Clozapine | Tablet; Oral | SUPPL-21 | Accord Hlthcare | Labeling | Approved |
| Clozapine
ANDA #202873 |
Clozapine | Tablet; Oral | SUPPL-17 | Accord Hlthcare | Labeling | Approved |
| Clozapine
ANDA #202873 |
Clozapine | Tablet; Oral | SUPPL-18 | Accord Hlthcare | Labeling | Approved |
| Clozapine
ANDA #202873 |
Clozapine | Tablet; Oral | SUPPL-21 | Accord Hlthcare | Labeling | Approved |
| Cyproheptadine Hydrochloride
ANDA #212491 |
Cyproheptadine Hydrochloride | Tablet; Oral | SUPPL-3 | Quagen | Manufacturing (CMC) | Approved |
| Cyprolara
ANDA #212491 |
Cyproheptadine Hydrochloride | Tablet; Oral | SUPPL-3 | Quagen | Manufacturing (CMC) | Approved |
| Divalproex Sodium
ANDA #078700 |
Divalproex Sodium | Tablet, Extended Release; Oral | SUPPL-6 | Cosette Pharms Nc | Labeling | Approved |
| Divalproex Sodium
ANDA #078700 |
Divalproex Sodium | Tablet, Extended Release; Oral | SUPPL-7 | Cosette Pharms Nc | Labeling | Approved |
| Divalproex Sodium
ANDA #078700 |
Divalproex Sodium | Tablet, Extended Release; Oral | SUPPL-5 | Cosette Pharms Nc | Labeling | Approved |
| Divalproex Sodium
ANDA #078700 |
Divalproex Sodium | Tablet, Extended Release; Oral | SUPPL-6 | Cosette Pharms Nc | Labeling | Approved |
| Divalproex Sodium
ANDA #078700 |
Divalproex Sodium | Tablet, Extended Release; Oral | SUPPL-7 | Cosette Pharms Nc | Labeling | Approved |
| Doxercalciferol
ANDA #091433 |
Doxercalciferol | Capsule; Oral | SUPPL-10 | Hikma Pharms | Labeling | Approved |
| Excedrin (Migraine Relief)
NDA #020802 |
Acetaminophen; Aspirin; Caffeine | Tablet; Oral | SUPPL-46 | Haleon Us Holdings | Labeling | Approved |
| Exenatide Synthetic
ANDA #206697 |
Exenatide Synthetic | Injectable; Subcutaneous | SUPPL-6 | Amneal | Labeling | Approved |
| Exenatide Synthetic
ANDA #206697 |
Exenatide Synthetic | Injectable; Subcutaneous | SUPPL-7 | Amneal | Labeling | Approved |
| Exenatide Synthetic
ANDA #206697 |
Exenatide Synthetic | Injectable; Subcutaneous | SUPPL-9 | Amneal | Labeling | Approved |
| Fosaprepitant Dimeglumine
ANDA #211860 |
Fosaprepitant Dimeglumine | Powder; Intravenous | SUPPL-2 | Baxter Hlthcare Corp | Labeling | Approved |
| Jaypirca
NDA #216059 |
Pirtobrutinib | Tablet; Oral | SUPPL-6 | Loxo Oncol | Efficacy | Approved |
| Methylphenidate Hydrochloride
ANDA #206840 |
Methylphenidate Hydrochloride | Tablet; Oral | SUPPL-7 | Alvogen | Labeling | Approved |
| Methylphenidate Hydrochloride
ANDA #206840 |
Methylphenidate Hydrochloride | Tablet; Oral | SUPPL-7 | Alvogen | Labeling | Approved |
| Perampanel
ANDA #220492 |
Perampanel | Tablet; Oral | ORIG-1 | Aurobindo Pharma Ltd | Approved |
October 1, 2026
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Carbidopa and Levodopa
ANDA #210341 |
Carbidopa; Levodopa | Tablet, Extended Release; Oral | SUPPL-6 | Alembic | Labeling | Approved |
| Carbidopa and Levodopa
ANDA #214091 |
Carbidopa; Levodopa | Tablet, Extended Release; Oral | SUPPL-13 | Sciegen Pharms | Labeling | Approved |
| Dapagliflozin
ANDA #219408 |
Dapagliflozin | Tablet | ORIG-1 | Sciegen Pharmaceuticals Inc | Tentative Approval | |
| Fentanyl Citrate Preservative Free
ANDA #210762 |
Fentanyl Citrate | Injectable; Injection | SUPPL-10 | Fresenius Kabi Usa | Labeling | Approved |
| Fentanyl Citrate Preservative Free
ANDA #210762 |
Fentanyl Citrate | Injectable; Injection | SUPPL-10 | Fresenius Kabi Usa | Labeling | Approved |
| Fentanyl Citrate Preservative Free
ANDA #210762 |
Fentanyl Citrate | Injectable; Injection | SUPPL-11 | Fresenius Kabi Usa | Labeling | Approved |
| Methylphenidate Hydrochloride
ANDA #210818 |
Methylphenidate Hydrochloride | Tablet, Extended Release; Oral | SUPPL-5 | Alvogen | Labeling | Approved |
| Methylphenidate Hydrochloride
ANDA #210818 |
Methylphenidate Hydrochloride | Tablet, Extended Release; Oral | SUPPL-6 | Alvogen | Labeling | Approved |
| Methylphenidate Hydrochloride
ANDA #210818 |
Methylphenidate Hydrochloride | Tablet, Extended Release; Oral | SUPPL-5 | Alvogen | Labeling | Approved |
| Methylphenidate Hydrochloride
ANDA #210818 |
Methylphenidate Hydrochloride | Tablet, Extended Release; Oral | SUPPL-6 | Alvogen | Labeling | Approved |
| Olanzapine
ANDA #201588 |
Olanzapine | Powder; Intramuscular | SUPPL-17 | Sandoz Inc | Labeling | Approved |
| Olanzapine
ANDA #201588 |
Olanzapine | Powder; Intramuscular | SUPPL-18 | Sandoz Inc | Labeling | Approved |
| Rozlytrek
NDA #212725 |
Entrectinib | Capsule; Oral | SUPPL-14 | Genentech Inc | Labeling | Approved |
| Rozlytrek
NDA #212725 |
Entrectinib | Capsule; Oral | SUPPL-14 | Genentech Inc | Labeling | Approved |
| Rozlytrek
NDA #218550 |
Entrectinib | Pellets; Oral | SUPPL-2 | Genentech Inc | Labeling | Approved |
| Rozlytrek
NDA #218550 |
Entrectinib | Pellets; Oral | SUPPL-2 | Genentech Inc | Labeling | Approved |
| Trabectedin
NDA #219617 |
Trabectedin | Injectable; Injection | ORIG-1 | Ever Valinject | Type 5 - New Formulation or New Manufacturer | Approved |
September 30, 2026
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Acetazolamide
ANDA #218023 |
Acetazolamide | Tablet; Oral | SUPPL-2 | Epic Pharma Llc | Labeling | Approved |
| Atomoxetine Hydrochloride
ANDA #218875 |
Atomoxetine Hydrochloride | Capsule; Oral | SUPPL-2 | Pharmazone | Labeling | Approved |
| Camzyos
NDA #214998 |
Mavacamten | Capsule; Oral | SUPPL-13 | Bristol | Efficacy | Approved |
| Celecoxib
ANDA #210628 |
Celecoxib | Capsule; Oral | SUPPL-18 | Pharmazone | Labeling | Approved |
| Doxepin Hydrochloride
ANDA #212624 |
Doxepin Hydrochloride | Capsule; Oral | SUPPL-20 | Ajanta Pharma Ltd | Labeling | Approved |
| Doxepin Hydrochloride
ANDA #212624 |
Doxepin Hydrochloride | Capsule; Oral | SUPPL-20 | Ajanta Pharma Ltd | Labeling | Approved |
| Doxepin Hydrochloride
ANDA #215076 |
Doxepin Hydrochloride | Capsule; Oral | SUPPL-9 | Alembic | Labeling | Approved |
| Doxepin Hydrochloride
ANDA #215076 |
Doxepin Hydrochloride | Capsule; Oral | SUPPL-9 | Alembic | Labeling | Approved |
| Indomethacin
ANDA #202139 |
Indomethacin | Capsule, Extended Release; Oral | SUPPL-7 | Mylan | Labeling | Approved |
| Indomethacin
ANDA #202139 |
Indomethacin | Capsule, Extended Release; Oral | SUPPL-7 | Mylan | Labeling | Approved |
| Levocarnitine
ANDA #220181 |
Levocarnitine | Injectable; Injection | ORIG-1 | Gland | Approved | |
| Loperamide Hydrochloride
ANDA #220722 |
Loperamide Hydrochloride | Capsule; Oral | ORIG-1 | Taro | Approved | |
| Matulane
NDA #016785 |
Procarbazine Hydrochloride | Capsule; Oral | SUPPL-44 | Leadiant Biosci Inc | Labeling | Approved |
| Methotrexate Sodium
ANDA #040263 |
Methotrexate Sodium | Injectable; Injection | SUPPL-24 | Fresenius Kabi Usa | Manufacturing (CMC) | Approved |
| Phytonadione
ANDA #219175 |
Phytonadione | Injectable; Injection | ORIG-1 | Lupin | Approved | |
| Xenical
NDA #020766 |
Orlistat | Capsule; Oral | SUPPL-39 | Cheplapharm | Labeling | Approved |
| Zepzelca
NDA #213702 |
Lurbinectedin | Powder; Intravenous | SUPPL-13 | Jazz | Labeling | Approved |
October 8, 2026
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Breztri Aerosphere
NDA #220290 |
Budesonide, Glycopyrrolate, and Formoterol Fumarate | Inhalant; Oral | ORIG-1 | Astrazeneca Ab | Type 5 - New Formulation or New Manufacturer | Approved |
| Carbidopa and Levodopa
ANDA #075091 |
Carbidopa; Levodopa | Tablet, Extended Release; Oral | SUPPL-36 | Mylan | Labeling | Approved |
| Fenofibrate
ANDA #211080 |
Fenofibrate | Tablet; Oral | SUPPL-3 | Prinston Inc | Labeling | Approved |
| Fenofibric Acid
ANDA #200264 |
Choline Fenofibrate | Capsule, Delayed Release; Oral | SUPPL-8 | Impax Labs Inc | Labeling | Approved |
| Fenofibric Acid
ANDA #212598 |
Choline Fenofibrate | Capsule, Delayed Release; Oral | SUPPL-6 | Aurobindo Pharma Ltd | Labeling | Approved |
| Oxcarbazepine
ANDA #218278 |
Oxcarbazepine | Suspension; Oral | SUPPL-2 | Biocon Pharma | Labeling | Approved |
| Oxcarbazepine
ANDA #218278 |
Oxcarbazepine | Suspension; Oral | SUPPL-2 | Biocon Pharma | Labeling | Approved |
| Pitolisant
ANDA #218832 |
Pitolisant | Tablet | ORIG-1 | Annora Pharma Private Limited | Approved | |
| Tafluprost
ANDA #209040 |
Tafluprost | Solution/Drops; Ophthalmic | SUPPL-2 | Sandoz | Labeling | Approved |
| Tafluprost
ANDA #209051 |
Tafluprost | Solution/Drops; Ophthalmic | SUPPL-3 | Micro Labs | Labeling | Approved |
| Tafluprost
ANDA #209051 |
Tafluprost | Solution/Drops; Ophthalmic | SUPPL-3 | Micro Labs | Labeling | Approved |
| Tecentriq
BLA #761034 |
Atezolizumab | Injectable; Injection | SUPPL-65 | Genentech Inc | Efficacy | Approved |
| Tecentriq Hybreza
BLA #761347 |
Atezolizumab and Hyaluronidase-Tqjs | Injectable; Injection | SUPPL-11 | Genentech Inc | Efficacy | Approved |
| Weltruza
NDA #219007 |
Olanzapine | Suspension, Extended Release; Injectable | ORIG-1 | Teva Neuroscience Inc | Type 5 - New Formulation or New Manufacturer | Approved |
October 7, 2026
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Absorica
NDA #021951 |
Isotretinoin | Capsule; Oral | SUPPL-32 | Sun Pharm Inds Inc | REMS | Approved |
| Absorica Ld
NDA #211913 |
Isotretinoin | Capsule; Oral | SUPPL-24 | Sun Pharm | REMS | Approved |
| Amnesteem
ANDA #075945 |
Isotretinoin | Capsule; Oral | SUPPL-53 | Mylan Pharms Inc | REMS | Approved |
| Claravis
ANDA #076135 |
Isotretinoin | Capsule; Oral | SUPPL-70 | Teva Pharms Usa | REMS | Approved |
| Claravis
ANDA #076356 |
Isotretinoin | Capsule; Oral | SUPPL-64 | Teva Pharms Usa | REMS | Approved |
| Duac
NDA #050741 |
Benzoyl Peroxide; Clindamycin Phosphate | Gel; Topical | SUPPL-26 | Stiefel | Labeling | Approved |
| Fidaxomicin
ANDA #219737 |
Fidaxomicin | Tablet; Oral | ORIG-1 | Hikma Pharms | Approved | |
| Hydrochlorothiazide
ANDA #218248 |
Hydrochlorothiazide | Solution; Oral | ORIG-1 | Rubicon Research | Approved | |
| Isotretinoin
ANDA #205063 |
Isotretinoin | Capsule; Oral | SUPPL-13 | Actavis Labs Fl | REMS | Approved |
| Isotretinoin
ANDA #207792 |
Isotretinoin | Capsule; Oral | SUPPL-38 | Amneal Pharms Ny | REMS | Approved |
| Isotretinoin
ANDA #211568 |
Isotretinoin | Capsule; Oral | SUPPL-9 | Zydus Pharms | REMS | Approved |
| Isotretinoin
ANDA #212333 |
Isotretinoin | Capsule; Oral | SUPPL-20 | Upsher Smith Labs | REMS | Approved |
| Isotretinoin
ANDA #213571 |
Isotretinoin | Capsule; Oral | SUPPL-19 | Upsher Smith Labs | REMS | Approved |
| Isotretinoin
ANDA #216097 |
Isotretinoin | Capsule; Oral | SUPPL-3 | Amneal Pharms Ny | REMS | Approved |
| Isotretinoin
ANDA #216633 |
Isotretinoin | Capsule; Oral | SUPPL-4 | Zydus Pharms | REMS | Approved |
| Isotretinoin
ANDA #218194 |
Isotretinoin | Capsule; Oral | SUPPL-6 | Aurobindo Pharma | REMS | Approved |
| Isotretinoin
ANDA #220336 |
Isotretinoin | Capsule; Oral | SUPPL-1 | Aurobindo Pharma Ltd | REMS | Approved |
| Mirabegron
ANDA #219599 |
Mirabegron | Tablet, Extended Release; Oral | ORIG-1 | Creekwood Pharms | Approved | |
| Myorisan
ANDA #076485 |
Isotretinoin | Capsule; Oral | SUPPL-49 | Upsher Smith Labs | REMS | Approved |
| Tukysa
NDA #213411 |
Tucatinib | Tablet; Oral | SUPPL-10 | Seagen | Efficacy | Approved |
| Zenatane
ANDA #202099 |
Isotretinoin | Capsule; Oral | SUPPL-43 | Dr Reddys Labs Ltd | REMS | Approved |
October 6, 2026
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Lisdexamfetamine Dimesylate
ANDA #216944 |
Lisdexamfetamine Dimesylate | Capsule; Oral | SUPPL-4 | Apotex | Labeling | Approved |
| Lisdexamfetamine Dimesylate
ANDA #216944 |
Lisdexamfetamine Dimesylate | Capsule; Oral | SUPPL-5 | Apotex | Labeling | Approved |
| Lisdexamfetamine Dimesylate
ANDA #216944 |
Lisdexamfetamine Dimesylate | Capsule; Oral | SUPPL-4 | Apotex | Labeling | Approved |
| Lisdexamfetamine Dimesylate
ANDA #216944 |
Lisdexamfetamine Dimesylate | Capsule; Oral | SUPPL-5 | Apotex | Labeling | Approved |
| Proglycem
NDA #017453 |
Diazoxide | Suspension; Oral | SUPPL-25 | Teva Branded Pharm | Labeling | Approved |
| Rhapsido
NDA #218436 |
Remibrutinib | Tablet; Oral | SUPPL-1 | Novartis | Efficacy | Approved |
| Sertraline Hydrochloride
NDA #215133 |
Sertraline Hydrochloride | Capsule; Oral | SUPPL-4 | Almatica | Labeling | Approved |
| Sodium Bicarbonate
NDA #218524 |
Sodium Bicarbonate | Solution; Intravenous | SUPPL-1 | Baxter Hlthcare Corp | Labeling | Approved |
| Sodium Bicarbonate
NDA #218524 |
Sodium Bicarbonate | Solution; Intravenous | SUPPL-1 | Baxter Hlthcare Corp | Labeling | Approved |
| Solriamfetol
ANDA #218725 |
Solriamfetol | Tablet | ORIG-1 | Aurobindo Pharma Ltd | Approved | |
| Solriamfetol Hydrochloride
ANDA #218725 |
Solriamfetol Hydrochloride | Tablet; Oral | ORIG-1 | Aurobindo Pharma Ltd | Approved | |
| Sugammadex Sodium
ANDA #215701 |
Sugammadex Sodium | Solution; Intravenous | ORIG-1 | Shandong | Approved | |
| Valsartan
ANDA #204011 |
Valsartan | Tablet; Oral | SUPPL-22 | Amneal Pharms | Labeling | Approved |
| Valsartan
ANDA #204011 |
Valsartan | Tablet; Oral | SUPPL-22 | Amneal Pharms | Labeling | Approved |
| Valsartan
ANDA #204011 |
Valsartan | Tablet; Oral | SUPPL-22 | Amneal Pharms | Labeling | Approved |
October 5, 2026
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Acthar Gel
NDA #008372 |
Corticotropin | Injectable; Injection | SUPPL-88 | Mallinckrodt Ireland | Labeling | Approved |
| Acthar Gel (Autoinjector)
NDA #008372 |
Corticotropin | Injectable; Injection | SUPPL-88 | Mallinckrodt Ireland | Labeling | Approved |
| Bupropion Hydrochloride
ANDA #208652 |
Bupropion Hydrochloride | Tablet, Extended Release; Oral | SUPPL-14 | Sinotherapeutics Inc | Labeling | Approved |
| Carbamazepine
ANDA #212524 |
Carbamazepine | Tablet, Extended Release; Oral | SUPPL-2 | Torrent | Labeling | Approved |
| Carbamazepine
ANDA #213159 |
Carbamazepine | Tablet, Extended Release; Oral | SUPPL-1 | Apotex | Labeling | Approved |
| Carbamazepine
ANDA #213159 |
Carbamazepine | Tablet, Extended Release; Oral | SUPPL-1 | Apotex | Labeling | Approved |
| Cortrophin-Zinc
NDA #009854 |
Corticotropin-Zinc Hydroxide | Injectable; Injection | SUPPL-13 | Ani Pharms | Labeling | Approved |
| Dexmethylphenidate Hydrochloride
ANDA #079108 |
Dexmethylphenidate Hydrochloride | Capsule, Extended Release; Oral | SUPPL-20 | Impax Labs Inc | Labeling | Approved |
| Dexmethylphenidate Hydrochloride
ANDA #079108 |
Dexmethylphenidate Hydrochloride | Capsule, Extended Release; Oral | SUPPL-20 | Impax Labs Inc | Labeling | Approved |
| Dextroamp Saccharate, Amp Aspartate, Dextroamp Sulfate and Amp Sulfate
ANDA #214403 |
Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Capsule, Extended Release; Oral | SUPPL-5 | Lannett Co Inc | Labeling | Approved |
| Dextroamp Saccharate, Amp Aspartate, Dextroamp Sulfate and Amp Sulfate
ANDA #214403 |
Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Capsule, Extended Release; Oral | SUPPL-6 | Lannett Co Inc | Labeling | Approved |
| Dextroamp Saccharate, Amp Aspartate, Dextroamp Sulfate and Amp Sulfate
ANDA #214403 |
Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Capsule, Extended Release; Oral | SUPPL-5 | Lannett Co Inc | Labeling | Approved |
| Dextroamp Saccharate, Amp Aspartate, Dextroamp Sulfate and Amp Sulfate
ANDA #214403 |
Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Capsule, Extended Release; Oral | SUPPL-6 | Lannett Co Inc | Labeling | Approved |
| Diclofenac Sodium
ANDA #210986 |
Diclofenac Sodium | Gel; Topical | SUPPL-27 | Encube | Labeling | Approved |
| Diclofenac Sodium
ANDA #210986 |
Diclofenac Sodium | Gel; Topical | SUPPL-27 | Encube | Labeling | Approved |
| Divalproex Sodium
ANDA #218793 |
Divalproex Sodium | Capsule, Delayed Rel Pellets; Oral | SUPPL-1 | Alembic | Labeling | Approved |
| Divalproex Sodium
ANDA #218793 |
Divalproex Sodium | Capsule, Delayed Rel Pellets; Oral | SUPPL-2 | Alembic | Labeling | Approved |
| Divalproex Sodium
ANDA #218793 |
Divalproex Sodium | Capsule, Delayed Rel Pellets; Oral | SUPPL-1 | Alembic | Labeling | Approved |
| Divalproex Sodium
ANDA #218793 |
Divalproex Sodium | Capsule, Delayed Rel Pellets; Oral | SUPPL-2 | Alembic | Labeling | Approved |
| Divalproex Sodium
ANDA #218793 |
Divalproex Sodium | Capsule, Delayed Rel Pellets; Oral | SUPPL-3 | Alembic | Labeling | Approved |
| Doxepin Hydrochloride
ANDA #213796 |
Doxepin Hydrochloride | Capsule; Oral | SUPPL-1 | Adaptis | Labeling | Approved |
| Moxifloxacin Hydrochloride
ANDA #205348 |
Moxifloxacin Hydrochloride | Tablet; Oral | SUPPL-8 | Crossmedika Sa | Labeling | Approved |
| Moxifloxacin Hydrochloride
ANDA #205348 |
Moxifloxacin Hydrochloride | Tablet; Oral | SUPPL-8 | Crossmedika Sa | Labeling | Approved |
| Purified Cortrophin Gel
NDA #008975 |
Corticotropin | Injectable; Injection | SUPPL-24 | Ani Pharms | Labeling | Approved |
| Topiramate
ANDA #215663 |
Topiramate | Capsule, Extended Release; Oral | SUPPL-6 | Ajanta Pharma Ltd | Labeling | Approved |
| Topiramate
ANDA #217248 |
Topiramate | Capsule, Extended Release; Oral | SUPPL-1 | Alkem Labs Ltd | Labeling | Approved |
| Topiramate
ANDA #217248 |
Topiramate | Capsule, Extended Release; Oral | SUPPL-2 | Alkem Labs Ltd | Labeling | Approved |
| Topiramate
ANDA #217248 |
Topiramate | Capsule, Extended Release; Oral | SUPPL-1 | Alkem Labs Ltd | Labeling | Approved |
| Topiramate
ANDA #217248 |
Topiramate | Capsule, Extended Release; Oral | SUPPL-2 | Alkem Labs Ltd | Labeling | Approved |
| Topiramate
ANDA #217248 |
Topiramate | Capsule, Extended Release; Oral | SUPPL-6 | Alkem Labs Ltd | Labeling | Approved |
October 2, 2026
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Celecoxib
ANDA #213301 |
Celecoxib | Capsule; Oral | SUPPL-6 | Unichem | Labeling | Approved |
| Celecoxib
ANDA #213301 |
Celecoxib | Capsule; Oral | SUPPL-6 | Unichem | Labeling | Approved |
| Clozapine
ANDA #075417 |
Clozapine | Tablet; Oral | SUPPL-64 | Mylan | Labeling | Approved |
| Clozapine
ANDA #075417 |
Clozapine | Tablet; Oral | SUPPL-64 | Mylan | Labeling | Approved |
| Clozapine
ANDA #075417 |
Clozapine | Tablet; Oral | SUPPL-61 | Mylan | Labeling | Approved |
| Clozapine
ANDA #075417 |
Clozapine | Tablet; Oral | SUPPL-62 | Mylan | Labeling | Approved |
| Clozapine
ANDA #075417 |
Clozapine | Tablet; Oral | SUPPL-64 | Mylan | Labeling | Approved |
| Clozapine
ANDA #202873 |
Clozapine | Tablet; Oral | SUPPL-21 | Accord Hlthcare | Labeling | Approved |
| Clozapine
ANDA #202873 |
Clozapine | Tablet; Oral | SUPPL-17 | Accord Hlthcare | Labeling | Approved |
| Clozapine
ANDA #202873 |
Clozapine | Tablet; Oral | SUPPL-18 | Accord Hlthcare | Labeling | Approved |
| Clozapine
ANDA #202873 |
Clozapine | Tablet; Oral | SUPPL-21 | Accord Hlthcare | Labeling | Approved |
| Cyproheptadine Hydrochloride
ANDA #212491 |
Cyproheptadine Hydrochloride | Tablet; Oral | SUPPL-3 | Quagen | Manufacturing (CMC) | Approved |
| Cyprolara
ANDA #212491 |
Cyproheptadine Hydrochloride | Tablet; Oral | SUPPL-3 | Quagen | Manufacturing (CMC) | Approved |
| Divalproex Sodium
ANDA #078700 |
Divalproex Sodium | Tablet, Extended Release; Oral | SUPPL-6 | Cosette Pharms Nc | Labeling | Approved |
| Divalproex Sodium
ANDA #078700 |
Divalproex Sodium | Tablet, Extended Release; Oral | SUPPL-7 | Cosette Pharms Nc | Labeling | Approved |
| Divalproex Sodium
ANDA #078700 |
Divalproex Sodium | Tablet, Extended Release; Oral | SUPPL-5 | Cosette Pharms Nc | Labeling | Approved |
| Divalproex Sodium
ANDA #078700 |
Divalproex Sodium | Tablet, Extended Release; Oral | SUPPL-6 | Cosette Pharms Nc | Labeling | Approved |
| Divalproex Sodium
ANDA #078700 |
Divalproex Sodium | Tablet, Extended Release; Oral | SUPPL-7 | Cosette Pharms Nc | Labeling | Approved |
| Doxercalciferol
ANDA #091433 |
Doxercalciferol | Capsule; Oral | SUPPL-10 | Hikma Pharms | Labeling | Approved |
| Excedrin (Migraine Relief)
NDA #020802 |
Acetaminophen; Aspirin; Caffeine | Tablet; Oral | SUPPL-46 | Haleon Us Holdings | Labeling | Approved |
| Exenatide Synthetic
ANDA #206697 |
Exenatide Synthetic | Injectable; Subcutaneous | SUPPL-6 | Amneal | Labeling | Approved |
| Exenatide Synthetic
ANDA #206697 |
Exenatide Synthetic | Injectable; Subcutaneous | SUPPL-7 | Amneal | Labeling | Approved |
| Exenatide Synthetic
ANDA #206697 |
Exenatide Synthetic | Injectable; Subcutaneous | SUPPL-9 | Amneal | Labeling | Approved |
| Fosaprepitant Dimeglumine
ANDA #211860 |
Fosaprepitant Dimeglumine | Powder; Intravenous | SUPPL-2 | Baxter Hlthcare Corp | Labeling | Approved |
| Jaypirca
NDA #216059 |
Pirtobrutinib | Tablet; Oral | SUPPL-6 | Loxo Oncol | Efficacy | Approved |
| Methylphenidate Hydrochloride
ANDA #206840 |
Methylphenidate Hydrochloride | Tablet; Oral | SUPPL-7 | Alvogen | Labeling | Approved |
| Methylphenidate Hydrochloride
ANDA #206840 |
Methylphenidate Hydrochloride | Tablet; Oral | SUPPL-7 | Alvogen | Labeling | Approved |
| Perampanel
ANDA #220492 |
Perampanel | Tablet; Oral | ORIG-1 | Aurobindo Pharma Ltd | Approved |
October 1, 2026
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Carbidopa and Levodopa
ANDA #210341 |
Carbidopa; Levodopa | Tablet, Extended Release; Oral | SUPPL-6 | Alembic | Labeling | Approved |
| Carbidopa and Levodopa
ANDA #214091 |
Carbidopa; Levodopa | Tablet, Extended Release; Oral | SUPPL-13 | Sciegen Pharms | Labeling | Approved |
| Dapagliflozin
ANDA #219408 |
Dapagliflozin | Tablet | ORIG-1 | Sciegen Pharmaceuticals Inc | Tentative Approval | |
| Fentanyl Citrate Preservative Free
ANDA #210762 |
Fentanyl Citrate | Injectable; Injection | SUPPL-10 | Fresenius Kabi Usa | Labeling | Approved |
| Fentanyl Citrate Preservative Free
ANDA #210762 |
Fentanyl Citrate | Injectable; Injection | SUPPL-10 | Fresenius Kabi Usa | Labeling | Approved |
| Fentanyl Citrate Preservative Free
ANDA #210762 |
Fentanyl Citrate | Injectable; Injection | SUPPL-11 | Fresenius Kabi Usa | Labeling | Approved |
| Methylphenidate Hydrochloride
ANDA #210818 |
Methylphenidate Hydrochloride | Tablet, Extended Release; Oral | SUPPL-5 | Alvogen | Labeling | Approved |
| Methylphenidate Hydrochloride
ANDA #210818 |
Methylphenidate Hydrochloride | Tablet, Extended Release; Oral | SUPPL-6 | Alvogen | Labeling | Approved |
| Methylphenidate Hydrochloride
ANDA #210818 |
Methylphenidate Hydrochloride | Tablet, Extended Release; Oral | SUPPL-5 | Alvogen | Labeling | Approved |
| Methylphenidate Hydrochloride
ANDA #210818 |
Methylphenidate Hydrochloride | Tablet, Extended Release; Oral | SUPPL-6 | Alvogen | Labeling | Approved |
| Olanzapine
ANDA #201588 |
Olanzapine | Powder; Intramuscular | SUPPL-17 | Sandoz Inc | Labeling | Approved |
| Olanzapine
ANDA #201588 |
Olanzapine | Powder; Intramuscular | SUPPL-18 | Sandoz Inc | Labeling | Approved |
| Rozlytrek
NDA #212725 |
Entrectinib | Capsule; Oral | SUPPL-14 | Genentech Inc | Labeling | Approved |
| Rozlytrek
NDA #212725 |
Entrectinib | Capsule; Oral | SUPPL-14 | Genentech Inc | Labeling | Approved |
| Rozlytrek
NDA #218550 |
Entrectinib | Pellets; Oral | SUPPL-2 | Genentech Inc | Labeling | Approved |
| Rozlytrek
NDA #218550 |
Entrectinib | Pellets; Oral | SUPPL-2 | Genentech Inc | Labeling | Approved |
| Trabectedin
NDA #219617 |
Trabectedin | Injectable; Injection | ORIG-1 | Ever Valinject | Type 5 - New Formulation or New Manufacturer | Approved |
September 30, 2026
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Acetazolamide
ANDA #218023 |
Acetazolamide | Tablet; Oral | SUPPL-2 | Epic Pharma Llc | Labeling | Approved |
| Atomoxetine Hydrochloride
ANDA #218875 |
Atomoxetine Hydrochloride | Capsule; Oral | SUPPL-2 | Pharmazone | Labeling | Approved |
| Camzyos
NDA #214998 |
Mavacamten | Capsule; Oral | SUPPL-13 | Bristol | Efficacy | Approved |
| Celecoxib
ANDA #210628 |
Celecoxib | Capsule; Oral | SUPPL-18 | Pharmazone | Labeling | Approved |
| Doxepin Hydrochloride
ANDA #212624 |
Doxepin Hydrochloride | Capsule; Oral | SUPPL-20 | Ajanta Pharma Ltd | Labeling | Approved |
| Doxepin Hydrochloride
ANDA #212624 |
Doxepin Hydrochloride | Capsule; Oral | SUPPL-20 | Ajanta Pharma Ltd | Labeling | Approved |
| Doxepin Hydrochloride
ANDA #215076 |
Doxepin Hydrochloride | Capsule; Oral | SUPPL-9 | Alembic | Labeling | Approved |
| Doxepin Hydrochloride
ANDA #215076 |
Doxepin Hydrochloride | Capsule; Oral | SUPPL-9 | Alembic | Labeling | Approved |
| Indomethacin
ANDA #202139 |
Indomethacin | Capsule, Extended Release; Oral | SUPPL-7 | Mylan | Labeling | Approved |
| Indomethacin
ANDA #202139 |
Indomethacin | Capsule, Extended Release; Oral | SUPPL-7 | Mylan | Labeling | Approved |
| Levocarnitine
ANDA #220181 |
Levocarnitine | Injectable; Injection | ORIG-1 | Gland | Approved | |
| Loperamide Hydrochloride
ANDA #220722 |
Loperamide Hydrochloride | Capsule; Oral | ORIG-1 | Taro | Approved | |
| Matulane
NDA #016785 |
Procarbazine Hydrochloride | Capsule; Oral | SUPPL-44 | Leadiant Biosci Inc | Labeling | Approved |
| Methotrexate Sodium
ANDA #040263 |
Methotrexate Sodium | Injectable; Injection | SUPPL-24 | Fresenius Kabi Usa | Manufacturing (CMC) | Approved |
| Phytonadione
ANDA #219175 |
Phytonadione | Injectable; Injection | ORIG-1 | Lupin | Approved | |
| Xenical
NDA #020766 |
Orlistat | Capsule; Oral | SUPPL-39 | Cheplapharm | Labeling | Approved |
| Zepzelca
NDA #213702 |
Lurbinectedin | Powder; Intravenous | SUPPL-13 | Jazz | Labeling | Approved |
September 29, 2026
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Avtozma
BLA #761420 |
Tocilizumab-Anoh | Injectable; Intravenous | SUPPL-8 | Celltrion Inc | Approved | |
| Avtozma
BLA #761420 |
Tocilizumab-Anoh | Injectable; Intravenous | SUPPL-8 | Celltrion Inc | Approved | |
| Avtozma
BLA #761420 |
Tocilizumab-Anoh | Injectable; Subcutaneous | SUPPL-8 | Celltrion Inc | Approved | |
| Avtozma
BLA #761420 |
Tocilizumab-Anoh | Injectable; Subcutaneous | SUPPL-8 | Celltrion Inc | Approved | |
| Avtozma
BLA #761498 |
Tocilizumab-Anoh | Injectable; Iv (Infusion) | SUPPL-3 | Celltrion Inc | Labeling | Approved |
| Avtozma
BLA #761498 |
Tocilizumab-Anoh | Injectable; Subcutaneous | SUPPL-3 | Celltrion Inc | Labeling | Approved |
| Azithromycin
ANDA #203294 |
Azithromycin | Injectable; Injection | SUPPL-18 | Eugia Pharma | Labeling | Approved |
| Celecoxib
ANDA #210071 |
Celecoxib | Capsule; Oral | SUPPL-5 | Cspc Ouyi | Labeling | Approved |
| Celecoxib
ANDA #210071 |
Celecoxib | Capsule; Oral | SUPPL-5 | Cspc Ouyi | Labeling | Approved |
| Celecoxib
ANDA #210071 |
Celecoxib | Capsule; Oral | SUPPL-5 | Cspc Ouyi | Labeling | Approved |
| Clozapine
ANDA #206433 |
Clozapine | Tablet; Oral | SUPPL-26 | Aurobindo Pharma | Labeling | Approved |
| Clozapine
ANDA #206433 |
Clozapine | Tablet; Oral | SUPPL-26 | Aurobindo Pharma | Labeling | Approved |
| Clozapine
ANDA #206433 |
Clozapine | Tablet; Oral | SUPPL-20 | Aurobindo Pharma | Labeling | Approved |
| Clozapine
ANDA #206433 |
Clozapine | Tablet; Oral | SUPPL-21 | Aurobindo Pharma | Labeling | Approved |
| Clozapine
ANDA #206433 |
Clozapine | Tablet; Oral | SUPPL-26 | Aurobindo Pharma | Labeling | Approved |
| Dapagliflozin
ANDA #211414 |
Dapagliflozin | Unknown | ORIG-1 | Bionpharma Inc | Tentative Approval | |
| Delstrigo
NDA #210807 |
Doravirine; Lamivudine; Tenofovir Disoproxil Fumarate | Tablet; Oral | SUPPL-19 | Msd Merck Co | Labeling | Approved |
| Dextrose 10% and Sodium Chloride 0.11% In Plastic Container
NDA #019631 |
Dextrose; Sodium Chloride | Injectable; Injection | SUPPL-53 | B Braun | Labeling | Approved |
| Dextrose 10% and Sodium Chloride 0.2% In Plastic Container
NDA #019631 |
Dextrose; Sodium Chloride | Injectable; Injection | SUPPL-53 | B Braun | Labeling | Approved |
| Dextrose 10% and Sodium Chloride 0.33% In Plastic Container
NDA #019631 |
Dextrose; Sodium Chloride | Injectable; Injection | SUPPL-53 | B Braun | Labeling | Approved |
| Dextrose 10% and Sodium Chloride 0.45% In Plastic Container
NDA #019631 |
Dextrose; Sodium Chloride | Injectable; Injection | SUPPL-53 | B Braun | Labeling | Approved |
| Dextrose 10% and Sodium Chloride 0.9% In Plastic Container
NDA #019631 |
Dextrose; Sodium Chloride | Injectable; Injection | SUPPL-53 | B Braun | Labeling | Approved |
| Dextrose 2.5% and Sodium Chloride 0.11% In Plastic Container
NDA #019631 |
Dextrose; Sodium Chloride | Injectable; Injection | SUPPL-53 | B Braun | Labeling | Approved |
| Dextrose 2.5% and Sodium Chloride 0.2% In Plastic Container
NDA #019631 |
Dextrose; Sodium Chloride | Injectable; Injection | SUPPL-53 | B Braun | Labeling | Approved |
| Dextrose 2.5% and Sodium Chloride 0.33% In Plastic Container
NDA #019631 |
Dextrose; Sodium Chloride | Injectable; Injection | SUPPL-53 | B Braun | Labeling | Approved |
| Dextrose 2.5% and Sodium Chloride 0.45% In Plastic Container
NDA #019631 |
Dextrose; Sodium Chloride | Injectable; Injection | SUPPL-53 | B Braun | Labeling | Approved |
| Dextrose 2.5% and Sodium Chloride 0.9% In Plastic Container
NDA #019631 |
Dextrose; Sodium Chloride | Injectable; Injection | SUPPL-53 | B Braun | Labeling | Approved |
| Dextrose 3.3% and Sodium Chloride 0.3% In Plastic Container
NDA #019631 |
Dextrose; Sodium Chloride | Injectable; Injection | SUPPL-53 | B Braun | Labeling | Approved |
| Dextrose 5% and Sodium Chloride 0.11% In Plastic Container
NDA #019631 |
Dextrose; Sodium Chloride | Injectable; Injection | SUPPL-53 | B Braun | Labeling | Approved |
| Dextrose 5% and Sodium Chloride 0.2% In Plastic Container
NDA #019631 |
Dextrose; Sodium Chloride | Injectable; Injection | SUPPL-53 | B Braun | Labeling | Approved |
| Dextrose 5% and Sodium Chloride 0.33% In Plastic Container
NDA #019631 |
Dextrose; Sodium Chloride | Injectable; Injection | SUPPL-53 | B Braun | Labeling | Approved |
| Dextrose 5% and Sodium Chloride 0.45% In Plastic Container
NDA #019631 |
Dextrose; Sodium Chloride | Injectable; Injection | SUPPL-53 | B Braun | Labeling | Approved |
| Dextrose 5% and Sodium Chloride 0.9% In Plastic Container
NDA #019631 |
Dextrose; Sodium Chloride | Injectable; Injection | SUPPL-53 | B Braun | Labeling | Approved |
| Eydenzelt
BLA #761377 |
Aflibercept-Boav | Injectable; Injection | SUPPL-2 | Celltrion Inc | Labeling | Approved |
| Eydenzelt
BLA #761377 |
Aflibercept-Boav | Injectable; Injection | SUPPL-2 | Celltrion Inc | Labeling | Approved |
| Fenofibrate (Micronized)
ANDA #201748 |
Fenofibrate | Capsule; Oral | SUPPL-11 | Sun Pharm Inds Ltd | Labeling | Approved |
| Lacosamide
ANDA #204857 |
Lacosamide | Tablet; Oral | SUPPL-4 | Amneal Pharms | Labeling | Approved |
| Lacosamide
ANDA #204857 |
Lacosamide | Tablet; Oral | SUPPL-8 | Amneal Pharms | Labeling | Approved |
| Lacosamide
ANDA #204857 |
Lacosamide | Tablet; Oral | SUPPL-9 | Amneal Pharms | Labeling | Approved |
| Lacosamide
ANDA #204857 |
Lacosamide | Tablet; Oral | SUPPL-4 | Amneal Pharms | Labeling | Approved |
| Lacosamide
ANDA #204857 |
Lacosamide | Tablet; Oral | SUPPL-8 | Amneal Pharms | Labeling | Approved |
| Lacosamide
ANDA #204857 |
Lacosamide | Tablet; Oral | SUPPL-9 | Amneal Pharms | Labeling | Approved |
| Mupirocin Calcium
ANDA #218361 |
Mupirocin Calcium | Cream; Topical | ORIG-1 | Zydus Lifesciences | Approved | |
| Pifeltro
NDA #210806 |
Doravirine | Tablet; Oral | SUPPL-14 | Msd Merck Co | Labeling | Approved |
| Ponlimsi
BLA #761385 |
Denosumab-Adet | Injectable; Subcutaneous | SUPPL-6 | Teva Pharmaceuticals, Inc. | Approved | |
| Riabni
BLA #761140 |
Rituximab-Arrx | Injectable; Injection | SUPPL-5 | Amgen Inc | Bioequivalence | Approved |
| Rifampin
ANDA #091181 |
Rifampin | Injectable; Injection | SUPPL-14 | Fresenius Kabi Usa | Labeling | Approved |
| Tranexamic Acid
ANDA #201580 |
Tranexamic Acid | Injectable; Injection | SUPPL-10 | Pharmobedient | Labeling | Approved |
September 28, 2026
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Aqvesme
NDA #216196 |
Mitapivat Sulfate | Tablet; Oral | SUPPL-7 | Agios Pharms Inc | Manufacturing (CMC) | Approved |
| Bumetanide
ANDA #074700 |
Bumetanide | Tablet; Oral | SUPPL-35 | Sandoz | Manufacturing (CMC) | Approved |
| Children's Zyrtec Allergy
NDA #021621 |
Cetirizine Hydrochloride | Tablet, Chewable; Oral | SUPPL-19 | Kenvue Brands | Manufacturing (CMC) | Approved |
| Children's Zyrtec Hives Relief
NDA #021621 |
Cetirizine Hydrochloride | Tablet, Chewable; Oral | SUPPL-19 | Kenvue Brands | Manufacturing (CMC) | Approved |
| Dexmedetomidine Hydrochloride
ANDA #216254 |
Dexmedetomidine Hydrochloride | Injectable; Injection | ORIG-1 | Nephron | Approved | |
| Dexmethylphenidate Hydrochloride
ANDA #077107 |
Dexmethylphenidate Hydrochloride | Tablet; Oral | SUPPL-15 | Teva Pharms | Labeling | Approved |
| Dexmethylphenidate Hydrochloride
ANDA #077107 |
Dexmethylphenidate Hydrochloride | Tablet; Oral | SUPPL-17 | Teva Pharms | Labeling | Approved |
| Dexmethylphenidate Hydrochloride
ANDA #077107 |
Dexmethylphenidate Hydrochloride | Tablet; Oral | SUPPL-14 | Teva Pharms | Labeling | Approved |
| Dexmethylphenidate Hydrochloride
ANDA #077107 |
Dexmethylphenidate Hydrochloride | Tablet; Oral | SUPPL-15 | Teva Pharms | Labeling | Approved |
| Dexmethylphenidate Hydrochloride
ANDA #077107 |
Dexmethylphenidate Hydrochloride | Tablet; Oral | SUPPL-17 | Teva Pharms | Labeling | Approved |
| Emcitate
NDA #220963 |
Tiratricol | Tablet; Oral | ORIG-1 | Rare Thyroid Therapeutics International Ab | Type 1 - New Molecular Entity | Approved |
| Labetalol Hydrochloride
ANDA #218870 |
Labetalol Hydrochloride | Injectable; Injection | SUPPL-5 | Amneal | Labeling | Approved |
| Methylphenidate Hydrochloride
ANDA #213473 |
Methylphenidate Hydrochloride | Tablet, Extended Release; Oral | SUPPL-4 | Granules | Labeling | Approved |
| Methylphenidate Hydrochloride
ANDA #213473 |
Methylphenidate Hydrochloride | Tablet, Extended Release; Oral | SUPPL-4 | Granules | Labeling | Approved |
| Methylphenidate Hydrochloride
ANDA #213473 |
Methylphenidate Hydrochloride | Tablet, Extended Release; Oral | SUPPL-5 | Granules | Labeling | Approved |
| Methylphenidate Hydrochloride
ANDA #213473 |
Methylphenidate Hydrochloride | Tablet, Extended Release; Oral | SUPPL-6 | Granules | Labeling | Approved |
| Methylphenidate Hydrochloride
ANDA #213473 |
Methylphenidate Hydrochloride | Tablet, Extended Release; Oral | SUPPL-5 | Granules | Labeling | Approved |
| Methylphenidate Hydrochloride
ANDA #213936 |
Methylphenidate Hydrochloride | Tablet; Oral | SUPPL-5 | Accord Hlthcare | Labeling | Approved |
| Methylphenidate Hydrochloride
ANDA #217229 |
Methylphenidate Hydrochloride | Tablet, Extended Release; Oral | SUPPL-5 | Sun Pharm Inds Inc | Labeling | Approved |
| Methylphenidate Hydrochloride
ANDA #217229 |
Methylphenidate Hydrochloride | Tablet, Extended Release; Oral | SUPPL-7 | Sun Pharm Inds Inc | Labeling | Approved |
| Methylphenidate Hydrochloride
ANDA #217229 |
Methylphenidate Hydrochloride | Tablet, Extended Release; Oral | SUPPL-5 | Sun Pharm Inds Inc | Labeling | Approved |
| Methylphenidate Hydrochloride
ANDA #217229 |
Methylphenidate Hydrochloride | Tablet, Extended Release; Oral | SUPPL-6 | Sun Pharm Inds Inc | Labeling | Approved |
| Methylphenidate Hydrochloride
ANDA #217229 |
Methylphenidate Hydrochloride | Tablet, Extended Release; Oral | SUPPL-7 | Sun Pharm Inds Inc | Labeling | Approved |
| Minocycline Hydrochloride
ANDA #065470 |
Minocycline Hydrochloride | Capsule; Oral | SUPPL-17 | Aurobindo Pharma | Labeling | Approved |
| Polyethylene Glycol 3350
ANDA #209017 |
Polyethylene Glycol 3350 | For Solution; Oral | SUPPL-5 | Aurobindo Pharma Ltd | Manufacturing (CMC) | Approved |
| Polyethylene Glycol 3350
ANDA #209017 |
Polyethylene Glycol 3350 | For Solution; Oral | SUPPL-5 | Aurobindo Pharma Ltd | Manufacturing (CMC) | Approved |
| Prednisolone Acetate
ANDA #212778 |
Prednisolone Acetate | Suspension/Drops; Ophthalmic | ORIG-1 | Upsher Smith Labs | Approved | |
| Pyrukynd
NDA #216196 |
Mitapivat Sulfate | Tablet; Oral | SUPPL-7 | Agios Pharms Inc | Manufacturing (CMC) | Approved |
| Quinapril Hydrochloride
ANDA #076694 |
Quinapril Hydrochloride | Tablet; Oral | SUPPL-17 | Pharmobedient | Labeling | Approved |
| Ruxience
BLA #761103 |
Rituximab-Pvvr | Injectable; Injection | SUPPL-20 | Pfizer Inc | Approved | |
| Tranexamic Acid
ANDA #203521 |
Tranexamic Acid | Injectable; Injection | SUPPL-26 | Avet Lifesciences | Labeling | Approved |
September 25, 2026
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Acyclovir
ANDA #204313 |
Acyclovir | Capsule; Oral | SUPPL-4 | Cadila | Labeling | Approved |
| Apixaban
NDA #220446 |
Apixaban | Suspension; Oral | ORIG-1 | Lupin | Type 3 - New Dosage Form | Tentative Approval |
| Argatroban In Sodium Chloride
NDA #022485 |
Argatroban | Injectable; Intravenous | SUPPL-15 | Plano Pharms | Labeling | Approved |
| Atebrioz
NDA #221198 |
Zilurgisertib | Tablet; Oral | ORIG-1 | Incyte Corp | Type 1 - New Molecular Entity | Approved |
| Atomoxetine Hydrochloride
ANDA #079019 |
Atomoxetine Hydrochloride | Capsule; Oral | SUPPL-18 | Glenmark Pharms Ltd | Labeling | Approved |
| Atomoxetine Hydrochloride
ANDA #079021 |
Atomoxetine Hydrochloride | Capsule; Oral | SUPPL-10 | Strides Pharma | Labeling | Approved |
| Atomoxetine Hydrochloride
ANDA #079021 |
Atomoxetine Hydrochloride | Capsule; Oral | SUPPL-10 | Strides Pharma | Labeling | Approved |
| Atovaquone and Proguanil Hydrochloride
ANDA #091211 |
Atovaquone; Proguanil Hydrochloride | Tablet; Oral | SUPPL-17 | Glenmark Pharms Ltd | Labeling | Approved |
| Atovaquone and Proguanil Hydrochloride
ANDA #091211 |
Atovaquone; Proguanil Hydrochloride | Tablet; Oral | SUPPL-15 | Glenmark Pharms Ltd | Labeling | Approved |
| Atovaquone and Proguanil Hydrochloride
ANDA #091211 |
Atovaquone; Proguanil Hydrochloride | Tablet; Oral | SUPPL-17 | Glenmark Pharms Ltd | Labeling | Approved |
| Bendamustine Hydrochloride
NDA #219014 |
Bendamustine Hydrochloride | Solution; Intravenous | SUPPL-2 | Avyxa Holdings | Labeling | Approved |
| Cabergoline
ANDA #078035 |
Cabergoline | Tablet; Oral | SUPPL-12 | Actavis Labs Fl Inc | Labeling | Approved |
| Cabergoline
ANDA #078035 |
Cabergoline | Tablet; Oral | SUPPL-12 | Actavis Labs Fl Inc | Labeling | Approved |
| Cabergoline
ANDA #078035 |
Cabergoline | Tablet; Oral | SUPPL-12 | Actavis Labs Fl Inc | Labeling | Approved |
| Capecitabine
ANDA #090943 |
Capecitabine | Tablet; Oral | SUPPL-16 | Rising | Labeling | Approved |
| Claritin
NDA #019658 |
Loratadine | Tablet; Oral | SUPPL-64 | Bayer Healthcare Llc | Labeling | Approved |
| Claritin Hives Relief
NDA #019658 |
Loratadine | Tablet; Oral | SUPPL-64 | Bayer Healthcare Llc | Labeling | Approved |
| Clomid
ANDA #075528 |
Clomiphene Citrate | Tablet; Oral | SUPPL-30 | Cosette | Manufacturing (CMC) | Approved |
| Clomid
ANDA #075528 |
Clomiphene Citrate | Tablet; Oral | SUPPL-30 | Cosette | Manufacturing (CMC) | Approved |
| Degevma
BLA #761481 |
Denosumab-Adet | Injectable; Subcutaneous | ORIG-1 | Teva Pharmaceuticals, Inc. | Type 5 - New Formulation or New Manufacturer | Approved |
| Diltiazem Hydrochloride
ANDA #220590 |
Diltiazem Hydrochloride | Tablet; Oral | ORIG-1 | Yichang Humanwell | Approved | |
| Dutasteride
ANDA #207935 |
Dutasteride | Capsule; Oral | SUPPL-1 | Heritage Pharms Inc | Labeling | Approved |
| Dutasteride
ANDA #207935 |
Dutasteride | Capsule; Oral | SUPPL-1 | Heritage Pharms Inc | Labeling | Approved |
| Esomeprazole Magnesium
ANDA #218687 |
Esomeprazole Magnesium | For Suspension, Delayed Release; Oral | ORIG-1 | Novitium Pharma | Approved | |
| Fingolimod Hydrochloride
ANDA #207991 |
Fingolimod Hydrochloride | Capsule; Oral | SUPPL-4 | Accord Hlthcare | Labeling | Approved |
| Fingolimod Hydrochloride
ANDA #208004 |
Fingolimod Hydrochloride | Capsule; Oral | SUPPL-9 | Alkem Labs Ltd | Labeling | Approved |
| Fingolimod Hydrochloride
ANDA #208004 |
Fingolimod Hydrochloride | Capsule; Oral | SUPPL-9 | Alkem Labs Ltd | Labeling | Approved |
| Fingolimod Hydrochloride
ANDA #208014 |
Fingolimod Hydrochloride | Capsule; Oral | SUPPL-7 | Sun Pharm | Labeling | Approved |
| Fingolimod Hydrochloride
ANDA #208014 |
Fingolimod Hydrochloride | Capsule; Oral | SUPPL-7 | Sun Pharm | Labeling | Approved |
| Gazyva
BLA #125486 |
Obinutuzumab | Injectable; Injection | SUPPL-43 | Genentech | Efficacy | Approved |
| Juvmo
NDA #220415 |
Tavapadon | Tablet; Oral | ORIG-1 | Abbvie Inc | Type 1 - New Molecular Entity | Approved |
| Ketoconazole
ANDA #091550 |
Ketoconazole | Aerosol, Foam; Topical | SUPPL-6 | Padagis Israel | Labeling | Approved |
| Ketorolac Tromethamine
ANDA #221041 |
Ketorolac Tromethamine | Injectable; Injection | ORIG-1 | Adaptis | Approved | |
| Lisdexamfetamine Dimesylate
ANDA #214547 |
Lisdexamfetamine Dimesylate | Capsule; Oral | SUPPL-8 | Norwich | Labeling | Approved |
| Lisdexamfetamine Dimesylate
ANDA #214547 |
Lisdexamfetamine Dimesylate | Capsule; Oral | SUPPL-11 | Norwich | Labeling | Approved |
| Lisdexamfetamine Dimesylate
ANDA #214547 |
Lisdexamfetamine Dimesylate | Capsule; Oral | SUPPL-8 | Norwich | Labeling | Approved |
| Lisdexamfetamine Dimesylate
ANDA #214547 |
Lisdexamfetamine Dimesylate | Capsule; Oral | SUPPL-11 | Norwich | Labeling | Approved |
| Losartan Potassium
ANDA #091129 |
Losartan Potassium | Tablet; Oral | SUPPL-11 | Watson Labs | Labeling | Approved |
| Losartan Potassium
ANDA #091129 |
Losartan Potassium | Tablet; Oral | SUPPL-11 | Watson Labs | Labeling | Approved |
| Metronidazole
ANDA #218485 |
Metronidazole | Gel; Vaginal | ORIG-1 | Aurobindo Pharma Ltd | Approved | |
| Nafcillin Sodium
ANDA #203830 |
Nafcillin Sodium | Injectable; Injection | ORIG-1 | Steriscience | Approved | |
| Olumiant
NDA #207924 |
Baricitinib | Tablet; Oral | SUPPL-9 | Eli Lilly and Co | Efficacy | Approved |
| Rosuvastatin Calcium
ANDA #079171 |
Rosuvastatin Calcium | Tablet; Oral | SUPPL-16 | Sandoz | Labeling | Approved |
| Rosuvastatin Calcium
ANDA #207752 |
Rosuvastatin Calcium | Tablet; Oral | SUPPL-31 | Biocon Pharma | Labeling | Approved |
| Thiamine Hydrochloride
ANDA #213131 |
Thiamine Hydrochloride | Injectable; Injection | ORIG-1 | Hong Kong | Approved | |
| Yusimry
BLA #761216 |
Adalimumab-Aqvh | Injectable; Injection | SUPPL-11 | Emerge Bioscience Pte Ltd | Approved | |
| Zueino
NDA #218379 |
Diclofenac Sodium | Injectable; Intravenous | ORIG-1 | Adventapharma Dwc Llc | Type 5 - New Formulation or New Manufacturer | Approved |