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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.

July 18, 2024

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Azilsartan Medoxomil
ANDA #214489
Azilsartan Kamedoxomil Tablet; Oral SUPPL-3 Lupin Ltd Labeling Approved
Dutasteride and Tamsulosin Hydrochloride
ANDA #213300
Dutasteride; Tamsulosin Hydrochloride Capsule; Oral ORIG-1 Aurobindo Pharma Approved
Midazolam In 0.9% Sodium Chloride
NDA #211844
Midazolam Solution; Intravenous SUPPL-5 Inforlife Labeling Approved
Minocin
NDA #050445
Minocycline Hydrochloride Suspension; Oral SUPPL-31 Bausch Labeling Approved
Minocin
NDA #050649
Minocycline Hydrochloride Capsule; Oral SUPPL-28 Bausch Labeling Approved
Minocin
NDA #050649
Minocycline Hydrochloride Capsule; Oral SUPPL-28 Bausch Labeling Approved
Pregabalin
ANDA #209664
Pregabalin Capsule; Oral SUPPL-7 Dr Reddys Labeling Approved
Pregabalin
ANDA #210432
Pregabalin Capsule; Oral SUPPL-10 Rising Labeling Approved
Proglycem
NDA #017453
Diazoxide Suspension; Oral SUPPL-24 Teva Branded Pharm Labeling Approved
Tenofovir Disoproxil Fumarate
ANDA #090742
Tenofovir Disoproxil Fumarate Tablet; Oral SUPPL-15 Strides Pharma Manufacturing (CMC) Approved

July 17, 2024

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Esomeprazole Magnesium
ANDA #213859
Esomeprazole Magnesium Capsule, Delayed Rel Pellets; Oral SUPPL-7 Guangzhou Novaken Labeling Approved
Esomeprazole Magnesium
ANDA #213859
Esomeprazole Magnesium Capsule, Delayed Rel Pellets; Oral SUPPL-10 Guangzhou Novaken Labeling Approved
Esomeprazole Magnesium
ANDA #213859
Esomeprazole Magnesium Capsule, Delayed Rel Pellets; Oral SUPPL-7 Guangzhou Novaken Labeling Approved
Esomeprazole Magnesium
ANDA #213859
Esomeprazole Magnesium Capsule, Delayed Rel Pellets; Oral SUPPL-10 Guangzhou Novaken Labeling Approved
Mesna
ANDA #075739
Mesna Injectable; Injection SUPPL-10 Hikma Labeling Approved
Mesna
ANDA #075739
Mesna Injectable; Injection SUPPL-7 Hikma Labeling Approved
Mesna
ANDA #075739
Mesna Injectable; Injection SUPPL-9 Hikma Labeling Approved
Mesna
ANDA #075739
Mesna Injectable; Intravenous SUPPL-10 Hikma Labeling Approved
Mesna
ANDA #075739
Mesna Injectable; Intravenous SUPPL-7 Hikma Labeling Approved
Mesna
ANDA #075739
Mesna Injectable; Intravenous SUPPL-9 Hikma Labeling Approved
Myfembree
NDA #214846
Estradiol; Norethindrone Acetate; Relugolix Tablet; Oral SUPPL-8 Myovant Sciences Labeling Approved
Palonosetron Hydrochloride
NDA #203050
Palonosetron Hydrochloride Solution; Intravenous SUPPL-2 Avyxa Holdings Labeling Approved
Sunlenca
NDA #215973
Lenacapavir Sodium Solution; Subcutaneous SUPPL-5 Gilead Sciences Inc Labeling Approved
Sunlenca
NDA #215974
Lenacapavir Sodium Tablet; Oral SUPPL-7 Gilead Sciences Inc Labeling Approved
Voquezna
NDA #215151
Vonoprazan Fumarate Tablet; Oral SUPPL-6 Phathom Labeling Approved
Voquezna
NDA #218710
Vonoprazan Fumarate Tablet; Oral ORIG-1 Phathom Pharmaceuticals Inc Type 9 - New Indication Submitted as Distinct NDA, Consolidated with Original NDA after Approval Approved
Zinc Sulfate
ANDA #216135
Zinc Sulfate Solution; Intravenous ORIG-1 Somerset Theraps Llc Approved

July 16, 2024

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Alesse
NDA #020683
Ethinyl Estradiol; Levonorgestrel Tablet; Oral-21 SUPPL-14 Cadence Health Labeling Approved
Alesse
NDA #020683
Ethinyl Estradiol; Levonorgestrel Tablet; Oral-28 SUPPL-14 Cadence Health Labeling Approved
Celecoxib
ANDA #204519
Celecoxib Capsule; Oral SUPPL-16 Alembic Labeling Approved
Celecoxib
ANDA #204519
Celecoxib Capsule; Oral SUPPL-16 Alembic Labeling Approved
Celecoxib
ANDA #207872
Celecoxib Capsule; Oral SUPPL-5 Tianjin Tianyao Labeling Approved
Celecoxib
ANDA #207872
Celecoxib Capsule; Oral SUPPL-5 Tianjin Tianyao Labeling Approved
Diltiazem Hydrochloride
ANDA #077686
Diltiazem Hydrochloride Tablet, Extended Release; Oral SUPPL-11 Actavis Labs Fl Inc Labeling Approved
Doxorubicin Hydrochloride (Liposomal)
ANDA #215178
Doxorubicin Hydrochloride Injectable, Liposomal; Injection ORIG-1 Fordoz Approved
Extended Phenytoin Sodium
ANDA #040684
Phenytoin Sodium Capsule; Oral SUPPL-7 Taro Labeling Approved
Extended Phenytoin Sodium
ANDA #040684
Phenytoin Sodium Capsule; Oral SUPPL-8 Taro Labeling Approved
Extended Phenytoin Sodium
ANDA #040684
Phenytoin Sodium Capsule; Oral SUPPL-9 Taro Labeling Approved
Extended Phenytoin Sodium
ANDA #040684
Phenytoin Sodium Capsule; Oral SUPPL-10 Taro Labeling Approved
Extended Phenytoin Sodium
ANDA #040684
Phenytoin Sodium Capsule; Oral SUPPL-13 Taro Labeling Approved
Extended Phenytoin Sodium
ANDA #040684
Phenytoin Sodium Capsule; Oral SUPPL-15 Taro Labeling Approved
Extended Phenytoin Sodium
ANDA #040684
Phenytoin Sodium Capsule; Oral SUPPL-16 Taro Labeling Approved
Extended Phenytoin Sodium
ANDA #040684
Phenytoin Sodium Capsule; Oral SUPPL-20 Taro Labeling Approved
Extended Phenytoin Sodium
ANDA #040684
Phenytoin Sodium Capsule; Oral SUPPL-21 Taro Labeling Approved
Extended Phenytoin Sodium
ANDA #040684
Phenytoin Sodium Capsule; Oral SUPPL-7 Taro Labeling Approved
Extended Phenytoin Sodium
ANDA #040684
Phenytoin Sodium Capsule; Oral SUPPL-8 Taro Labeling Approved
Extended Phenytoin Sodium
ANDA #040684
Phenytoin Sodium Capsule; Oral SUPPL-9 Taro Labeling Approved
Extended Phenytoin Sodium
ANDA #040684
Phenytoin Sodium Capsule; Oral SUPPL-10 Taro Labeling Approved
Extended Phenytoin Sodium
ANDA #040684
Phenytoin Sodium Capsule; Oral SUPPL-12 Taro Labeling Approved
Extended Phenytoin Sodium
ANDA #040684
Phenytoin Sodium Capsule; Oral SUPPL-13 Taro Labeling Approved
Extended Phenytoin Sodium
ANDA #040684
Phenytoin Sodium Capsule; Oral SUPPL-15 Taro Labeling Approved
Extended Phenytoin Sodium
ANDA #040684
Phenytoin Sodium Capsule; Oral SUPPL-16 Taro Labeling Approved
Extended Phenytoin Sodium
ANDA #040684
Phenytoin Sodium Capsule; Oral SUPPL-20 Taro Labeling Approved
Extended Phenytoin Sodium
ANDA #040684
Phenytoin Sodium Capsule; Oral SUPPL-21 Taro Labeling Approved
Fluconazole
ANDA #079150
Fluconazole For Suspension; Oral SUPPL-26 Aurobindo Pharma Labeling Approved
Fluconazole In Sodium Chloride 0.9% In Plastic Container
ANDA #076766
Fluconazole Injectable; Injection SUPPL-17 Baxter Hlthcare Labeling Approved
Formoterol Fumarate
ANDA #215883
Formoterol Fumarate Solution; Inhalation SUPPL-3 Mankind Pharma Manufacturing (CMC) Approved
Gabapentin
ANDA #075539
Gabapentin Capsule; Oral SUPPL-6 Sandoz Labeling Approved
Gabapentin
ANDA #075539
Gabapentin Capsule; Oral SUPPL-7 Sandoz Labeling Approved
Gabapentin
ANDA #075539
Gabapentin Capsule; Oral SUPPL-8 Sandoz Labeling Approved
Gabapentin
ANDA #075539
Gabapentin Capsule; Oral SUPPL-4 Sandoz Labeling Approved
Gabapentin
ANDA #075539
Gabapentin Capsule; Oral SUPPL-5 Sandoz Labeling Approved
Gabapentin
ANDA #075539
Gabapentin Capsule; Oral SUPPL-6 Sandoz Labeling Approved
Gabapentin
ANDA #075539
Gabapentin Capsule; Oral SUPPL-7 Sandoz Labeling Approved
Gabapentin
ANDA #075539
Gabapentin Capsule; Oral SUPPL-8 Sandoz Labeling Approved
Inlyta
NDA #202324
Axitinib Tablet; Oral SUPPL-16 Pf Prism Cv Labeling Approved
Levocarnitine
ANDA #075567
Levocarnitine Injectable; Injection SUPPL-14 Hikma Labeling Approved
Levocarnitine
ANDA #075567
Levocarnitine Injectable; Injection SUPPL-13 Hikma Labeling Approved
Levocarnitine
ANDA #075567
Levocarnitine Injectable; Injection SUPPL-14 Hikma Labeling Approved
Levothyroxine Sodium
ANDA #216414
Levothyroxine Sodium Tablet; Oral ORIG-1 Aurobindo Pharma Approved
Testosterone
ANDA #076744
Testosterone Gel; Transdermal SUPPL-18 Strides Pharma Labeling Approved
Testosterone
ANDA #076744
Testosterone Gel; Transdermal SUPPL-18 Strides Pharma Labeling Approved
Testosterone
ANDA #076744
Testosterone Gel; Transdermal SUPPL-18 Strides Pharma Labeling Approved
Topiramate
ANDA #217869
Topiramate Capsule; Oral ORIG-1 Glenmark Pharms Ltd Approved

July 15, 2024

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Atorvastatin Calcium
ANDA #077575
Atorvastatin Calcium Tablet; Oral SUPPL-16 Sandoz Inc Labeling Approved
Atorvastatin Calcium
ANDA #077575
Atorvastatin Calcium Tablet; Oral SUPPL-16 Sandoz Inc Labeling Approved
Clobazam
ANDA #209687
Clobazam Tablet; Oral SUPPL-8 Upsher Smith Labs Labeling Approved
Clobazam
ANDA #209687
Clobazam Tablet; Oral SUPPL-8 Upsher Smith Labs Labeling Approved
Clobazam
ANDA #210546
Clobazam Suspension; Oral SUPPL-5 Lupin Ltd Labeling Approved
Clobazam
ANDA #210546
Clobazam Suspension; Oral SUPPL-5 Lupin Ltd Labeling Approved
Clobazam
ANDA #210746
Clobazam Suspension; Oral SUPPL-10 Vistapharm Labeling Approved
Clobazam
ANDA #210746
Clobazam Suspension; Oral SUPPL-10 Vistapharm Labeling Approved
Clobazam
ANDA #210746
Clobazam Suspension; Oral SUPPL-10 Vistapharm Labeling Approved
Clobazam
ANDA #213404
Clobazam Tablet; Oral SUPPL-2 Msn Labeling Approved
Clobazam
ANDA #213404
Clobazam Tablet; Oral SUPPL-2 Msn Labeling Approved
Diclofenac Sodium
ANDA #209903
Diclofenac Sodium Gel; Topical SUPPL-10 Cipla Manufacturing (CMC) Approved
Diclofenac Sodium
ANDA #209903
Diclofenac Sodium Gel; Topical SUPPL-10 Cipla Manufacturing (CMC) Approved
Divalproex Sodium
ANDA #078597
Divalproex Sodium Tablet, Delayed Release; Oral SUPPL-40 Sun Pharm Inds Labeling Approved
Divalproex Sodium
ANDA #078597
Divalproex Sodium Tablet, Delayed Release; Oral SUPPL-40 Sun Pharm Inds Labeling Approved
Divalproex Sodium
ANDA #213181
Divalproex Sodium Capsule, Delayed Rel Pellets; Oral SUPPL-18 Ajanta Pharma Ltd Labeling Approved
Divalproex Sodium
ANDA #213181
Divalproex Sodium Capsule, Delayed Rel Pellets; Oral SUPPL-18 Ajanta Pharma Ltd Labeling Approved
Ezetimibe and Simvastatin
ANDA #209222
Ezetimibe; Simvastatin Tablet; Oral SUPPL-14 Alkem Labs Ltd Labeling Approved
Ezetimibe and Simvastatin
ANDA #209222
Ezetimibe; Simvastatin Tablet; Oral SUPPL-14 Alkem Labs Ltd Labeling Approved
Fentanyl Citrate Preservative Free
ANDA #072786
Fentanyl Citrate Injectable; Injection SUPPL-45 Hospira Labeling Approved
Glipizide
ANDA #214874
Glipizide Tablet; Oral SUPPL-2 Rubicon Labeling Approved
Meperidine Hydrochloride
ANDA #040191
Meperidine Hydrochloride Tablet; Oral SUPPL-19 Strides Pharma Labeling Approved
Nadolol
ANDA #208832
Nadolol Tablet; Oral SUPPL-7 Amneal Pharms Co Labeling Approved
Paroxetine
ANDA #203854
Paroxetine Hydrochloride Tablet; Oral SUPPL-3 Prinston Inc Labeling Approved
Paroxetine
ANDA #203854
Paroxetine Hydrochloride Tablet; Oral SUPPL-3 Prinston Inc Labeling Approved
Paroxetine
ANDA #203854
Paroxetine Hydrochloride Tablet; Oral SUPPL-4 Prinston Inc Labeling Approved
Paroxetine
ANDA #203854
Paroxetine Hydrochloride Tablet; Oral SUPPL-3 Prinston Inc Labeling Approved
Paroxetine
ANDA #203854
Paroxetine Hydrochloride Tablet; Oral SUPPL-4 Prinston Inc Labeling Approved
Paroxetine
ANDA #203854
Paroxetine Hydrochloride Tablet; Oral SUPPL-4 Prinston Inc Labeling Approved
Pregabalin
ANDA #209743
Pregabalin Capsule; Oral SUPPL-18 Amneal Pharms Co Labeling Approved
Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate
ANDA #209941
Magnesium Sulfate; Potassium Sulfate; Sodium Sulfate Solution; Oral ORIG-1 Lannett Co Inc Approved
Sodium Sulfate; Magnesium Sulfate; Potassium Chloride
ANDA #216095
Sodium Sulfate;Magnesium Sulfate;Potassium Chloride Tablet; Oral ORIG-1 Lupin Ltd Tentative Approval
Tazarotene
ANDA #217075
Tazarotene Cream; Topical ORIG-1 Padagis Israel Approved
Temozolomide
ANDA #204639
Temozolomide Capsule; Oral SUPPL-3 Chemi Spa Labeling Approved
Temozolomide
ANDA #206309
Temozolomide Capsule; Oral SUPPL-4 Rising Labeling Approved
Triamterene and Hydrochlorothiazide
ANDA #074821
Hydrochlorothiazide; Triamterene Capsule; Oral SUPPL-42 Sandoz Labeling Approved

July 14, 2024

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Risperidone
ANDA #076440
Risperidone Solution; Oral SUPPL-6 Ani Pharms Labeling Approved
Risperidone
ANDA #076440
Risperidone Solution; Oral SUPPL-7 Ani Pharms Labeling Approved
Risperidone
ANDA #078040
Risperidone Tablet; Oral SUPPL-28 Zydus Pharms Usa Inc Labeling Approved
Risperidone
ANDA #078040
Risperidone Tablet; Oral SUPPL-29 Zydus Pharms Usa Inc Labeling Approved

July 18, 2024

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Azilsartan Medoxomil
ANDA #214489
Azilsartan Kamedoxomil Tablet; Oral SUPPL-3 Lupin Ltd Labeling Approved
Dutasteride and Tamsulosin Hydrochloride
ANDA #213300
Dutasteride; Tamsulosin Hydrochloride Capsule; Oral ORIG-1 Aurobindo Pharma Approved
Midazolam In 0.9% Sodium Chloride
NDA #211844
Midazolam Solution; Intravenous SUPPL-5 Inforlife Labeling Approved
Minocin
NDA #050445
Minocycline Hydrochloride Suspension; Oral SUPPL-31 Bausch Labeling Approved
Minocin
NDA #050649
Minocycline Hydrochloride Capsule; Oral SUPPL-28 Bausch Labeling Approved
Minocin
NDA #050649
Minocycline Hydrochloride Capsule; Oral SUPPL-28 Bausch Labeling Approved
Pregabalin
ANDA #209664
Pregabalin Capsule; Oral SUPPL-7 Dr Reddys Labeling Approved
Pregabalin
ANDA #210432
Pregabalin Capsule; Oral SUPPL-10 Rising Labeling Approved
Proglycem
NDA #017453
Diazoxide Suspension; Oral SUPPL-24 Teva Branded Pharm Labeling Approved
Tenofovir Disoproxil Fumarate
ANDA #090742
Tenofovir Disoproxil Fumarate Tablet; Oral SUPPL-15 Strides Pharma Manufacturing (CMC) Approved

July 17, 2024

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Esomeprazole Magnesium
ANDA #213859
Esomeprazole Magnesium Capsule, Delayed Rel Pellets; Oral SUPPL-7 Guangzhou Novaken Labeling Approved
Esomeprazole Magnesium
ANDA #213859
Esomeprazole Magnesium Capsule, Delayed Rel Pellets; Oral SUPPL-10 Guangzhou Novaken Labeling Approved
Esomeprazole Magnesium
ANDA #213859
Esomeprazole Magnesium Capsule, Delayed Rel Pellets; Oral SUPPL-7 Guangzhou Novaken Labeling Approved
Esomeprazole Magnesium
ANDA #213859
Esomeprazole Magnesium Capsule, Delayed Rel Pellets; Oral SUPPL-10 Guangzhou Novaken Labeling Approved
Mesna
ANDA #075739
Mesna Injectable; Injection SUPPL-10 Hikma Labeling Approved
Mesna
ANDA #075739
Mesna Injectable; Injection SUPPL-7 Hikma Labeling Approved
Mesna
ANDA #075739
Mesna Injectable; Injection SUPPL-9 Hikma Labeling Approved
Mesna
ANDA #075739
Mesna Injectable; Intravenous SUPPL-10 Hikma Labeling Approved
Mesna
ANDA #075739
Mesna Injectable; Intravenous SUPPL-7 Hikma Labeling Approved
Mesna
ANDA #075739
Mesna Injectable; Intravenous SUPPL-9 Hikma Labeling Approved
Myfembree
NDA #214846
Estradiol; Norethindrone Acetate; Relugolix Tablet; Oral SUPPL-8 Myovant Sciences Labeling Approved
Palonosetron Hydrochloride
NDA #203050
Palonosetron Hydrochloride Solution; Intravenous SUPPL-2 Avyxa Holdings Labeling Approved
Sunlenca
NDA #215973
Lenacapavir Sodium Solution; Subcutaneous SUPPL-5 Gilead Sciences Inc Labeling Approved
Sunlenca
NDA #215974
Lenacapavir Sodium Tablet; Oral SUPPL-7 Gilead Sciences Inc Labeling Approved
Voquezna
NDA #215151
Vonoprazan Fumarate Tablet; Oral SUPPL-6 Phathom Labeling Approved
Voquezna
NDA #218710
Vonoprazan Fumarate Tablet; Oral ORIG-1 Phathom Pharmaceuticals Inc Type 9 - New Indication Submitted as Distinct NDA, Consolidated with Original NDA after Approval Approved
Zinc Sulfate
ANDA #216135
Zinc Sulfate Solution; Intravenous ORIG-1 Somerset Theraps Llc Approved

July 16, 2024

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Alesse
NDA #020683
Ethinyl Estradiol; Levonorgestrel Tablet; Oral-21 SUPPL-14 Cadence Health Labeling Approved
Alesse
NDA #020683
Ethinyl Estradiol; Levonorgestrel Tablet; Oral-28 SUPPL-14 Cadence Health Labeling Approved
Celecoxib
ANDA #204519
Celecoxib Capsule; Oral SUPPL-16 Alembic Labeling Approved
Celecoxib
ANDA #204519
Celecoxib Capsule; Oral SUPPL-16 Alembic Labeling Approved
Celecoxib
ANDA #207872
Celecoxib Capsule; Oral SUPPL-5 Tianjin Tianyao Labeling Approved
Celecoxib
ANDA #207872
Celecoxib Capsule; Oral SUPPL-5 Tianjin Tianyao Labeling Approved
Diltiazem Hydrochloride
ANDA #077686
Diltiazem Hydrochloride Tablet, Extended Release; Oral SUPPL-11 Actavis Labs Fl Inc Labeling Approved
Doxorubicin Hydrochloride (Liposomal)
ANDA #215178
Doxorubicin Hydrochloride Injectable, Liposomal; Injection ORIG-1 Fordoz Approved
Extended Phenytoin Sodium
ANDA #040684
Phenytoin Sodium Capsule; Oral SUPPL-7 Taro Labeling Approved
Extended Phenytoin Sodium
ANDA #040684
Phenytoin Sodium Capsule; Oral SUPPL-8 Taro Labeling Approved
Extended Phenytoin Sodium
ANDA #040684
Phenytoin Sodium Capsule; Oral SUPPL-9 Taro Labeling Approved
Extended Phenytoin Sodium
ANDA #040684
Phenytoin Sodium Capsule; Oral SUPPL-10 Taro Labeling Approved
Extended Phenytoin Sodium
ANDA #040684
Phenytoin Sodium Capsule; Oral SUPPL-13 Taro Labeling Approved
Extended Phenytoin Sodium
ANDA #040684
Phenytoin Sodium Capsule; Oral SUPPL-15 Taro Labeling Approved
Extended Phenytoin Sodium
ANDA #040684
Phenytoin Sodium Capsule; Oral SUPPL-16 Taro Labeling Approved
Extended Phenytoin Sodium
ANDA #040684
Phenytoin Sodium Capsule; Oral SUPPL-20 Taro Labeling Approved
Extended Phenytoin Sodium
ANDA #040684
Phenytoin Sodium Capsule; Oral SUPPL-21 Taro Labeling Approved
Extended Phenytoin Sodium
ANDA #040684
Phenytoin Sodium Capsule; Oral SUPPL-7 Taro Labeling Approved
Extended Phenytoin Sodium
ANDA #040684
Phenytoin Sodium Capsule; Oral SUPPL-8 Taro Labeling Approved
Extended Phenytoin Sodium
ANDA #040684
Phenytoin Sodium Capsule; Oral SUPPL-9 Taro Labeling Approved
Extended Phenytoin Sodium
ANDA #040684
Phenytoin Sodium Capsule; Oral SUPPL-10 Taro Labeling Approved
Extended Phenytoin Sodium
ANDA #040684
Phenytoin Sodium Capsule; Oral SUPPL-12 Taro Labeling Approved
Extended Phenytoin Sodium
ANDA #040684
Phenytoin Sodium Capsule; Oral SUPPL-13 Taro Labeling Approved
Extended Phenytoin Sodium
ANDA #040684
Phenytoin Sodium Capsule; Oral SUPPL-15 Taro Labeling Approved
Extended Phenytoin Sodium
ANDA #040684
Phenytoin Sodium Capsule; Oral SUPPL-16 Taro Labeling Approved
Extended Phenytoin Sodium
ANDA #040684
Phenytoin Sodium Capsule; Oral SUPPL-20 Taro Labeling Approved
Extended Phenytoin Sodium
ANDA #040684
Phenytoin Sodium Capsule; Oral SUPPL-21 Taro Labeling Approved
Fluconazole
ANDA #079150
Fluconazole For Suspension; Oral SUPPL-26 Aurobindo Pharma Labeling Approved
Fluconazole In Sodium Chloride 0.9% In Plastic Container
ANDA #076766
Fluconazole Injectable; Injection SUPPL-17 Baxter Hlthcare Labeling Approved
Formoterol Fumarate
ANDA #215883
Formoterol Fumarate Solution; Inhalation SUPPL-3 Mankind Pharma Manufacturing (CMC) Approved
Gabapentin
ANDA #075539
Gabapentin Capsule; Oral SUPPL-6 Sandoz Labeling Approved
Gabapentin
ANDA #075539
Gabapentin Capsule; Oral SUPPL-7 Sandoz Labeling Approved
Gabapentin
ANDA #075539
Gabapentin Capsule; Oral SUPPL-8 Sandoz Labeling Approved
Gabapentin
ANDA #075539
Gabapentin Capsule; Oral SUPPL-4 Sandoz Labeling Approved
Gabapentin
ANDA #075539
Gabapentin Capsule; Oral SUPPL-5 Sandoz Labeling Approved
Gabapentin
ANDA #075539
Gabapentin Capsule; Oral SUPPL-6 Sandoz Labeling Approved
Gabapentin
ANDA #075539
Gabapentin Capsule; Oral SUPPL-7 Sandoz Labeling Approved
Gabapentin
ANDA #075539
Gabapentin Capsule; Oral SUPPL-8 Sandoz Labeling Approved
Inlyta
NDA #202324
Axitinib Tablet; Oral SUPPL-16 Pf Prism Cv Labeling Approved
Levocarnitine
ANDA #075567
Levocarnitine Injectable; Injection SUPPL-14 Hikma Labeling Approved
Levocarnitine
ANDA #075567
Levocarnitine Injectable; Injection SUPPL-13 Hikma Labeling Approved
Levocarnitine
ANDA #075567
Levocarnitine Injectable; Injection SUPPL-14 Hikma Labeling Approved
Levothyroxine Sodium
ANDA #216414
Levothyroxine Sodium Tablet; Oral ORIG-1 Aurobindo Pharma Approved
Testosterone
ANDA #076744
Testosterone Gel; Transdermal SUPPL-18 Strides Pharma Labeling Approved
Testosterone
ANDA #076744
Testosterone Gel; Transdermal SUPPL-18 Strides Pharma Labeling Approved
Testosterone
ANDA #076744
Testosterone Gel; Transdermal SUPPL-18 Strides Pharma Labeling Approved
Topiramate
ANDA #217869
Topiramate Capsule; Oral ORIG-1 Glenmark Pharms Ltd Approved

July 15, 2024

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Atorvastatin Calcium
ANDA #077575
Atorvastatin Calcium Tablet; Oral SUPPL-16 Sandoz Inc Labeling Approved
Atorvastatin Calcium
ANDA #077575
Atorvastatin Calcium Tablet; Oral SUPPL-16 Sandoz Inc Labeling Approved
Clobazam
ANDA #209687
Clobazam Tablet; Oral SUPPL-8 Upsher Smith Labs Labeling Approved
Clobazam
ANDA #209687
Clobazam Tablet; Oral SUPPL-8 Upsher Smith Labs Labeling Approved
Clobazam
ANDA #210546
Clobazam Suspension; Oral SUPPL-5 Lupin Ltd Labeling Approved
Clobazam
ANDA #210546
Clobazam Suspension; Oral SUPPL-5 Lupin Ltd Labeling Approved
Clobazam
ANDA #210746
Clobazam Suspension; Oral SUPPL-10 Vistapharm Labeling Approved
Clobazam
ANDA #210746
Clobazam Suspension; Oral SUPPL-10 Vistapharm Labeling Approved
Clobazam
ANDA #210746
Clobazam Suspension; Oral SUPPL-10 Vistapharm Labeling Approved
Clobazam
ANDA #213404
Clobazam Tablet; Oral SUPPL-2 Msn Labeling Approved
Clobazam
ANDA #213404
Clobazam Tablet; Oral SUPPL-2 Msn Labeling Approved
Diclofenac Sodium
ANDA #209903
Diclofenac Sodium Gel; Topical SUPPL-10 Cipla Manufacturing (CMC) Approved
Diclofenac Sodium
ANDA #209903
Diclofenac Sodium Gel; Topical SUPPL-10 Cipla Manufacturing (CMC) Approved
Divalproex Sodium
ANDA #078597
Divalproex Sodium Tablet, Delayed Release; Oral SUPPL-40 Sun Pharm Inds Labeling Approved
Divalproex Sodium
ANDA #078597
Divalproex Sodium Tablet, Delayed Release; Oral SUPPL-40 Sun Pharm Inds Labeling Approved
Divalproex Sodium
ANDA #213181
Divalproex Sodium Capsule, Delayed Rel Pellets; Oral SUPPL-18 Ajanta Pharma Ltd Labeling Approved
Divalproex Sodium
ANDA #213181
Divalproex Sodium Capsule, Delayed Rel Pellets; Oral SUPPL-18 Ajanta Pharma Ltd Labeling Approved
Ezetimibe and Simvastatin
ANDA #209222
Ezetimibe; Simvastatin Tablet; Oral SUPPL-14 Alkem Labs Ltd Labeling Approved
Ezetimibe and Simvastatin
ANDA #209222
Ezetimibe; Simvastatin Tablet; Oral SUPPL-14 Alkem Labs Ltd Labeling Approved
Fentanyl Citrate Preservative Free
ANDA #072786
Fentanyl Citrate Injectable; Injection SUPPL-45 Hospira Labeling Approved
Glipizide
ANDA #214874
Glipizide Tablet; Oral SUPPL-2 Rubicon Labeling Approved
Meperidine Hydrochloride
ANDA #040191
Meperidine Hydrochloride Tablet; Oral SUPPL-19 Strides Pharma Labeling Approved
Nadolol
ANDA #208832
Nadolol Tablet; Oral SUPPL-7 Amneal Pharms Co Labeling Approved
Paroxetine
ANDA #203854
Paroxetine Hydrochloride Tablet; Oral SUPPL-3 Prinston Inc Labeling Approved
Paroxetine
ANDA #203854
Paroxetine Hydrochloride Tablet; Oral SUPPL-3 Prinston Inc Labeling Approved
Paroxetine
ANDA #203854
Paroxetine Hydrochloride Tablet; Oral SUPPL-4 Prinston Inc Labeling Approved
Paroxetine
ANDA #203854
Paroxetine Hydrochloride Tablet; Oral SUPPL-3 Prinston Inc Labeling Approved
Paroxetine
ANDA #203854
Paroxetine Hydrochloride Tablet; Oral SUPPL-4 Prinston Inc Labeling Approved
Paroxetine
ANDA #203854
Paroxetine Hydrochloride Tablet; Oral SUPPL-4 Prinston Inc Labeling Approved
Pregabalin
ANDA #209743
Pregabalin Capsule; Oral SUPPL-18 Amneal Pharms Co Labeling Approved
Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate
ANDA #209941
Magnesium Sulfate; Potassium Sulfate; Sodium Sulfate Solution; Oral ORIG-1 Lannett Co Inc Approved
Sodium Sulfate; Magnesium Sulfate; Potassium Chloride
ANDA #216095
Sodium Sulfate;Magnesium Sulfate;Potassium Chloride Tablet; Oral ORIG-1 Lupin Ltd Tentative Approval
Tazarotene
ANDA #217075
Tazarotene Cream; Topical ORIG-1 Padagis Israel Approved
Temozolomide
ANDA #204639
Temozolomide Capsule; Oral SUPPL-3 Chemi Spa Labeling Approved
Temozolomide
ANDA #206309
Temozolomide Capsule; Oral SUPPL-4 Rising Labeling Approved
Triamterene and Hydrochlorothiazide
ANDA #074821
Hydrochlorothiazide; Triamterene Capsule; Oral SUPPL-42 Sandoz Labeling Approved

July 14, 2024

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Risperidone
ANDA #076440
Risperidone Solution; Oral SUPPL-6 Ani Pharms Labeling Approved
Risperidone
ANDA #076440
Risperidone Solution; Oral SUPPL-7 Ani Pharms Labeling Approved
Risperidone
ANDA #078040
Risperidone Tablet; Oral SUPPL-28 Zydus Pharms Usa Inc Labeling Approved
Risperidone
ANDA #078040
Risperidone Tablet; Oral SUPPL-29 Zydus Pharms Usa Inc Labeling Approved

July 12, 2024

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Azithromycin
ANDA #065302
Azithromycin Tablet; Oral SUPPL-12 Chartwell Rx Labeling Approved
Azithromycin
ANDA #065404
Azithromycin Tablet; Oral SUPPL-15 Chartwell Rx Labeling Approved
Azithromycin
ANDA #065404
Azithromycin Tablet; Oral SUPPL-15 Chartwell Rx Labeling Approved
Azithromycin
ANDA #065405
Azithromycin Tablet; Oral SUPPL-14 Chartwell Rx Labeling Approved
Azithromycin
ANDA #065405
Azithromycin Tablet; Oral SUPPL-14 Chartwell Rx Labeling Approved
Azithromycin
ANDA #065405
Azithromycin Tablet; Oral SUPPL-14 Chartwell Rx Labeling Approved
Estradiol
ANDA #216055
Estradiol Gel; Transdermal ORIG-1 Amneal Approved
Estradiol
ANDA #217863
Estradiol Gel; Transdermal ORIG-1 Solaris Pharma Corp Approved
Neurontin
NDA #020235
Gabapentin Capsule; Oral SUPPL-76 Viatris Labeling Approved
Neurontin
NDA #020235
Gabapentin Capsule; Oral SUPPL-76 Viatris Labeling Approved
Neurontin
NDA #020882
Gabapentin Tablet; Oral SUPPL-57 Viatris Labeling Approved
Neurontin
NDA #020882
Gabapentin Tablet; Oral SUPPL-57 Viatris Labeling Approved
Neurontin
NDA #021129
Gabapentin Solution; Oral SUPPL-56 Viatris Labeling Approved
Neurontin
NDA #021129
Gabapentin Solution; Oral SUPPL-56 Viatris Labeling Approved
Nicotine Polacrilex
ANDA #077007
Nicotine Polacrilex Troche/Lozenge; Oral SUPPL-51 Perrigo R and D Manufacturing (CMC) Approved
Olopatadine Hydrochloride
ANDA #209015
Olopatadine Hydrochloride Solution/Drops; Ophthalmic ORIG-1 Apotex Inc Tentative Approval
Robinul
NDA #017558
Glycopyrrolate Injectable; Injection SUPPL-63 Hikma Manufacturing (CMC) Approved
Rocuronium Bromide
ANDA #204918
Rocuronium Bromide Injectable; Injection ORIG-1 Mylan Labs Ltd Approved
Rocuronium Bromide
ANDA #215684
Rocuronium Bromide Injectable; Injection ORIG-1 Shandong Approved
Sevelamer Carbonate
ANDA #206234
Sevelamer Carbonate For Suspension; Oral ORIG-1 Invagen Pharms Approved
Tacrolimus
ANDA #206651
Tacrolimus Capsule; Oral SUPPL-7 Belcher Labeling Approved
Travoprost
ANDA #218159
Travoprost Solution/Drops; Ophthalmic ORIG-1 Gland Pharma Ltd Approved

July 11, 2024

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Amondys 45
NDA #213026
Casimersen Solution; Intravenous SUPPL-8 Sarepta Theraps Inc Labeling Approved
Amoxicillin and Clavulanate Potassium
ANDA #217805
Amoxicillin; Clavulanate Potassium For Suspension; Oral SUPPL-1 Micro Labs Labeling Approved
Atorvastatin Calcium
ANDA #217081
Atorvastatin Calcium Tablet; Oral SUPPL-6 Mankind Pharma Labeling Approved
Atorvastatin Calcium
ANDA #217081
Atorvastatin Calcium Tablet; Oral SUPPL-6 Mankind Pharma Labeling Approved
Atorvastatin Calcium
ANDA #217081
Atorvastatin Calcium Tablet; Oral SUPPL-6 Mankind Pharma Labeling Approved
Atorvastatin Calcium
ANDA #217118
Atorvastatin Calcium Tablet; Oral SUPPL-1 Aurobindo Pharma Ltd Labeling Approved
Bosentan
ANDA #209742
Bosentan Tablet; Oral SUPPL-6 Amneal Pharms Co Labeling Approved
Bosentan
ANDA #209742
Bosentan Tablet; Oral SUPPL-6 Amneal Pharms Co Labeling Approved
Bosentan
ANDA #209742
Bosentan Tablet; Oral SUPPL-7 Amneal Pharms Co Labeling Approved
Bosentan
ANDA #209742
Bosentan Tablet; Oral SUPPL-6 Amneal Pharms Co Labeling Approved
Bosentan
ANDA #209742
Bosentan Tablet; Oral SUPPL-7 Amneal Pharms Co Labeling Approved
Bupropion Hydrochloride
ANDA #216800
Bupropion Hydrochloride Tablet, Extended Release; Oral SUPPL-1 Annora Pharma Labeling Approved
Depo-Provera
NDA #020246
Medroxyprogesterone Acetate Injectable; Injection SUPPL-68 Pfizer Labeling Approved
Depo-Subq Provera 104
NDA #021583
Medroxyprogesterone Acetate Injectable; Subcutaneous SUPPL-40 Pfizer Labeling Approved
Diclofenac Sodium
ANDA #074514
Diclofenac Sodium Tablet, Delayed Release; Oral SUPPL-46 Actavis Elizabeth Labeling Approved
Diclofenac Sodium
ANDA #074514
Diclofenac Sodium Tablet, Delayed Release; Oral SUPPL-46 Actavis Elizabeth Labeling Approved
Diclofenac Sodium
ANDA #074514
Diclofenac Sodium Tablet, Delayed Release; Oral SUPPL-46 Actavis Elizabeth Labeling Approved
Doxycycline
ANDA #217170
Doxycycline Capsule; Oral ORIG-1 Apotex Approved
Emtricitabine and Tenofovir Disoproxil Fumarate
ANDA #090894
Emtricitabine; Tenofovir Disoproxil Fumarate Tablet; Oral SUPPL-13 Teva Pharms Usa Labeling Approved
Emtricitabine and Tenofovir Disoproxil Fumarate
ANDA #090894
Emtricitabine; Tenofovir Disoproxil Fumarate Tablet; Oral SUPPL-13 Teva Pharms Usa Labeling Approved
Emtricitabine and Tenofovir Disoproxil Fumarate
ANDA #208740
Emtricitabine; Tenofovir Disoproxil Fumarate Tablet; Oral SUPPL-1 Apotex Labeling Approved
Ertugliflozin
ANDA #216947
Ertugliflozin Tablet; Oral SUPPL-1 Aurobindo Pharma Ltd Labeling Approved
Ertugliflozin
ANDA #216947
Ertugliflozin Tablet; Oral SUPPL-1 Aurobindo Pharma Ltd Labeling Approved
Fluoxetine Hydrochloride
ANDA #075207
Fluoxetine Hydrochloride Capsule; Oral SUPPL-26 Norvium Bioscience Labeling Approved
Fluoxetine Hydrochloride
ANDA #075207
Fluoxetine Hydrochloride Capsule; Oral SUPPL-26 Norvium Bioscience Labeling Approved
Fluvastatin Sodium
ANDA #209397
Fluvastatin Sodium Tablet, Extended Release; Oral SUPPL-3 Beijing Labeling Approved
Hydrochlorothiazide and Olmesartan Medoxomil
ANDA #207037
Hydrochlorothiazide; Olmesartan Medoxomil Tablet; Oral ORIG-1 Alkem Labs Ltd Approved
Hydroxychloroquine Sulfate
ANDA #040133
Hydroxychloroquine Sulfate Tablet; Oral SUPPL-32 Watson Labs Labeling Approved
Hydroxychloroquine Sulfate
ANDA #040133
Hydroxychloroquine Sulfate Tablet; Oral SUPPL-33 Watson Labs Labeling Approved
Hydroxychloroquine Sulfate
ANDA #040133
Hydroxychloroquine Sulfate Tablet; Oral SUPPL-34 Watson Labs Labeling Approved
Ibandronate Sodium
ANDA #203987
Ibandronate Sodium Injectable; Intravenous SUPPL-9 Avet Lifesciences Labeling Approved
Ibandronate Sodium
ANDA #203987
Ibandronate Sodium Injectable; Intravenous SUPPL-9 Avet Lifesciences Labeling Approved
Ibandronate Sodium
ANDA #204222
Ibandronate Sodium Injectable; Intravenous SUPPL-3 Apotex Labeling Approved
Ibandronate Sodium
ANDA #204222
Ibandronate Sodium Injectable; Intravenous SUPPL-3 Apotex Labeling Approved
Ketorolac Tromethamine
ANDA #075222
Ketorolac Tromethamine Injectable; Injection SUPPL-22 Hikma Labeling Approved
Ketorolac Tromethamine
ANDA #075228
Ketorolac Tromethamine Injectable; Injection SUPPL-19 Hikma Labeling Approved
Lanreotide Acetate
NDA #215395
Lanreotide Acetate Solution; Subcutaneous SUPPL-8 Invagen Pharms Labeling Approved
Mekinist
NDA #204114
Trametinib Dimethyl Sulfoxide Tablet; Oral SUPPL-33 Novartis Labeling Approved
Mekinist
NDA #217513
Trametinib Solution; Oral SUPPL-4 Novartis Labeling Approved
Mekinist
NDA #217513
Trametinib Tablet; Oral SUPPL-4 Novartis Labeling Approved
Mekinist
NDA #217513
Trametinib Dimethyl Sulfoxide Solution; Oral SUPPL-4 Novartis Labeling Approved
Mycapssa
NDA #208232
Octreotide Acetate Capsule, Delayed Release; Oral SUPPL-6 Chiesi Labeling Approved
Mycapssa
NDA #208232
Octreotide Acetate Capsule, Delayed Release; Oral SUPPL-6 Chiesi Labeling Approved
Nadolol
ANDA #211763
Nadolol Tablet; Oral SUPPL-2 Alembic Labeling Approved
Nadolol
ANDA #211763
Nadolol Tablet; Oral SUPPL-2 Alembic Labeling Approved
Potassium Phosphates
ANDA #217726
Potassium Phosphate, Dibasic; Potassium Phosphate, Monobasic Solution; Intravenous ORIG-1 Somerset Theraps Llc Approved
Pregabalin
ANDA #208677
Pregabalin Capsule; Oral SUPPL-17 Sciegen Pharms Inc Labeling Approved
Propranolol Hydrochloride
ANDA #212026
Propranolol Hydrochloride Capsule, Extended Release; Oral SUPPL-7 Amta Labeling Approved
Risedronate Sodium
ANDA #203822
Risedronate Sodium Tablet, Delayed Release; Oral SUPPL-1 Zydus Pharms Labeling Approved
Risedronate Sodium
ANDA #203822
Risedronate Sodium Tablet, Delayed Release; Oral SUPPL-1 Zydus Pharms Labeling Approved
Sandostatin
NDA #019667
Octreotide Acetate Injectable; Injection SUPPL-78 Novartis Labeling Approved
Sandostatin Lar
NDA #021008
Octreotide Acetate Injectable; Injection SUPPL-49 Novartis Labeling Approved
Selexipag
ANDA #217717
Selexipag Injectable; Injection ORIG-1 Alembic Pharms Ltd Tentative Approval
Signifor
NDA #200677
Pasireotide Diaspartate Solution; Subcutaneous SUPPL-12 Recordati Rare Labeling Approved
Signifor Lar Kit
NDA #203255
Pasireotide Pamoate For Suspension; Intramuscular SUPPL-11 Recordati Rare Labeling Approved
Signifor Lar Kit
NDA #203255
Pasireotide Pamoate For Suspension; Intramuscular SUPPL-11 Recordati Rare Labeling Approved
Somatuline Depot
NDA #022074
Lanreotide Acetate Solution; Subcutaneous SUPPL-32 Ipsen Pharma Labeling Approved
Tafinlar
NDA #202806
Dabrafenib Mesylate Capsule; Oral SUPPL-31 Novartis Labeling Approved
Tafinlar
NDA #217514
Dabrafenib Mesylate Capsule; Oral SUPPL-4 Novartis Labeling Approved
Tafinlar
NDA #217514
Dabrafenib Mesylate Tablet, For Suspension; Oral SUPPL-4 Novartis Labeling Approved
Tafinlar
NDA #217514
Dabrafenib Mesylate Tablet; Oral Suspension SUPPL-4 Novartis Labeling Approved
Topiramate
ANDA #215561
Topiramate Capsule, Extended Release; Oral ORIG-1 Lupin Ltd Approved
Vasopressin In Sodium Chloride Injection
NDA #217766
Vasopressin Solution; Intravenous ORIG-1 Long Grove Pharms Type 3 - New Dosage Form Approved
Xyzal Allergy 24hr
NDA #209089
Levocetirizine Dihydrochloride Tablet; Oral SUPPL-7 Chattem Sanofi Labeling Approved

July 10, 2024

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Atorvastatin Calcium
ANDA #206536
Atorvastatin Calcium Tablet; Oral SUPPL-18 Zydus Pharms Labeling Approved
Brineura
BLA #761052
Cerliponase Alfa Injectable; Injection SUPPL-16 Biomarin Pharm Labeling Approved
Cerezyme
BLA #020367
Imiglucerase Injectable; Injection SUPPL-121 Genzyme Labeling Approved
Clobazam
ANDA #210978
Clobazam Suspension; Oral SUPPL-7 Taro Labeling Approved
Clobazam
ANDA #210978
Clobazam Suspension; Oral SUPPL-7 Taro Labeling Approved
Cyanocobalamin
ANDA #217839
Cyanocobalamin Injectable; Injection ORIG-1 Mankind Pharma Approved
Divalproex Sodium
ANDA #090070
Divalproex Sodium Tablet, Extended Release; Oral SUPPL-25 Reddys Labeling Approved
Divalproex Sodium
ANDA #090161
Divalproex Sodium Tablet, Extended Release; Oral SUPPL-25 Dr Reddys Labs Ltd Labeling Approved
Divalproex Sodium
ANDA #090161
Divalproex Sodium Tablet, Extended Release; Oral SUPPL-25 Dr Reddys Labs Ltd Labeling Approved
Divalproex Sodium
ANDA #209286
Divalproex Sodium Tablet, Extended Release; Oral SUPPL-11 Lupin Ltd Labeling Approved
Divalproex Sodium
ANDA #209286
Divalproex Sodium Tablet, Extended Release; Oral SUPPL-11 Lupin Ltd Labeling Approved
Divalproex Sodium
ANDA #214462
Divalproex Sodium Tablet, Extended Release; Oral SUPPL-2 Amta Labeling Approved
Divalproex Sodium
ANDA #214462
Divalproex Sodium Tablet, Extended Release; Oral SUPPL-2 Amta Labeling Approved
Elelyso
BLA #022458
Taliglucerase Alfa Powder; Intravenous SUPPL-31 Pfizer Labeling Approved
Eliglustat Tartrate
ANDA #212425
Eliglustat Tartrate Capsule; Oral ORIG-1 Apotex Approved
Ezetimibe
ANDA #208803
Ezetimibe Tablet; Oral SUPPL-14 Amneal Pharms Co Labeling Approved
Ezetimibe
ANDA #208803
Ezetimibe Tablet; Oral SUPPL-14 Amneal Pharms Co Labeling Approved
Ezetimibe
ANDA #210859
Ezetimibe Tablet; Oral SUPPL-5 Hetero Labs Ltd Iii Labeling Approved
Ezetimibe
ANDA #215693
Ezetimibe Tablet; Oral SUPPL-3 Orient Pharma Labeling Approved
Ezetimibe and Simvastatin
ANDA #200082
Ezetimibe; Simvastatin Tablet; Oral SUPPL-2 Aurobindo Pharma Usa Labeling Approved
Ezetimibe and Simvastatin
ANDA #200082
Ezetimibe; Simvastatin Tablet; Oral SUPPL-2 Aurobindo Pharma Usa Labeling Approved
Fabrazyme
BLA #103979
Agalsidase Beta Vial; Intravenous SUPPL-5313 Genzyme Labeling Approved
Glycopyrrolate
ANDA #212696
Glycopyrrolate Tablet; Oral ORIG-1 Quagen Approved
Itraconazole
ANDA #205080
Itraconazole Capsule; Oral SUPPL-16 Amneal Pharms Labeling Approved
Itraconazole
ANDA #205080
Itraconazole Capsule; Oral SUPPL-16 Amneal Pharms Labeling Approved
Kanuma
BLA #125561
Sebelipase Alfa Injectable; Injection SUPPL-20 Alexion Pharm Labeling Approved
Loteprednol Etabonate
ANDA #215203
Loteprednol Etabonate Suspension/Drops; Ophthalmic ORIG-1 Padagis Us Approved
Lotrimin Ultra
NDA #021307
Butenafine Hydrochloride Cream; Topical SUPPL-24 Bayer Healthcare Llc Labeling Approved
Metoprolol Tartrate and Hydrochlorothiazide
ANDA #076792
Hydrochlorothiazide; Metoprolol Tartrate Tablet; Oral SUPPL-37 Mylan Labeling Approved
Multrys
NDA #209376
Cupric Sulfate; Manganese Sulfate; Selenious Acid; Zinc Sulfate Solution; Intravenous SUPPL-7 Am Regent Labeling Approved
Naglazyme
BLA #125117
Galsulfase Injectable; Injection SUPPL-131 Biomarin Labeling Approved
Solu-Cortef
NDA #009866
Hydrocortisone Sodium Succinate Injectable; Injection SUPPL-120 Pharmacia and Upjohn Labeling Approved
Strensiq
BLA #125513
Asfotase Alfa Solution; Injection SUPPL-33 Alexion Pharm Labeling Approved
Strensiq
BLA #125513
Asfotase Alfa Solution; Injection SUPPL-33 Alexion Pharm Labeling Approved
Tralement
NDA #209376
Cupric Sulfate; Manganese Sulfate; Selenious Acid; Zinc Sulfate Solution; Intravenous SUPPL-7 Am Regent Labeling Approved
Vpriv
BLA #022575
Velaglucerase Alfa Injectable; Intravenous SUPPL-30 Shire Human Genetic Labeling Approved
Vpriv
BLA #022575
Velaglucerase Alfa Powder; Intravenous SUPPL-30 Shire Human Genetic Labeling Approved

July 9, 2024

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Azathioprine Sodium
ANDA #074419
Azathioprine Sodium Injectable; Injection SUPPL-18 Hikma Labeling Approved
Diroximel Fumarate
ANDA #218596
Diroximel Fumarate Capsule, Delayed Release; Oral ORIG-1 Zydus Pharms Usa Inc Tentative Approval
Erleada
NDA #210951
Apalutamide Tablet; Oral SUPPL-17 Janssen Biotech Manufacturing (CMC) Approved
Esmolol Hydrochloride
ANDA #205520
Esmolol Hydrochloride Injectable; Injection SUPPL-7 Eugia Pharma Labeling Approved
Esmolol Hydrochloride
ANDA #216244
Esmolol Hydrochloride Injectable; Injection SUPPL-2 Eugia Pharma Labeling Approved
Imuran
NDA #016324
Azathioprine Tablet; Oral SUPPL-40 Sebela Ireland Ltd Labeling Approved
Imuran
NDA #017391
Azathioprine Sodium Injectable; Injection SUPPL-18 Casper Pharma Llc Labeling Approved
Nimodipine
ANDA #216937
Nimodipine Solution; Oral ORIG-1 Annora Pharma Approved
Octreotide Acetate
ANDA #203765
Octreotide Acetate Injectable; Injection SUPPL-6 Heritage Pharms Labeling Approved
Octreotide Acetate
ANDA #204669
Octreotide Acetate Injectable; Injection SUPPL-6 Heritage Pharms Labeling Approved
Purinethol
NDA #009053
Mercaptopurine Tablet; Oral SUPPL-44 Stason Pharms Labeling Approved
Purixan
NDA #205919
Mercaptopurine Suspension; Oral SUPPL-8 Nova Labs Ltd Labeling Approved
Sacubitril and Valsartan
ANDA #213719
Sacubitril; Valsartan Tablet; Oral ORIG-1 Zydus Pharms Approved
Succinylcholine Chloride
ANDA #217873
Succinylcholine Chloride Solution; Intramuscular, Intravenous ORIG-1 Steriscience Approved
Thioguanine
NDA #012429
Thioguanine Tablet; Oral SUPPL-29 Waylis Therap Labeling Approved
Zoryve
NDA #215985
Roflumilast Cream; Topical SUPPL-7 Arcutis Efficacy Approved

July 8, 2024

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Arsenic Trioxide
ANDA #206228
Arsenic Trioxide Injectable; Injection SUPPL-4 Zydus Pharms Labeling Approved
Azithromycin
ANDA #215772
Azithromycin Tablet; Oral SUPPL-4 Aci Manufacturing (CMC) Approved
Bismuth Subsalicylate, Metronidazole and Tetracycline Hydrochloride
ANDA #202584
Bismuth Subsalicylate; Metronidazole; Tetracycline Hydrochloride Tablet, Chewable, Tablet, Capsule; Oral SUPPL-3 Nostrum Labs Inc Labeling Approved
Bromfenac Sodium
ANDA #207334
Bromfenac Sodium Solution/Drops; Ophthalmic ORIG-1 Apotex Approved
Bromfenac Sodium
ANDA #214340
Bromfenac Sodium Solution/Drops; Ophthalmic ORIG-1 Alembic Approved
Calcium Chloride
ANDA #217524
Calcium Chloride Injectable; Injection ORIG-1 Amneal Approved
Captopril
ANDA #074737
Captopril Tablet; Oral SUPPL-13 Corepharma Labeling Approved
Captopril
ANDA #074737
Captopril Tablet; Oral SUPPL-13 Corepharma Labeling Approved
Celestone Soluspan
NDA #014602
Betamethasone Acetate; Betamethasone Sodium Phosphate Injectable; Injection SUPPL-64 Organon Labeling Approved
Chlordiazepoxide Hydrochloride and Clidinium Bromide
ANDA #212344
Chlordiazepoxide Hydrochloride; Clidinium Bromide Capsule; Oral ORIG-1 Winder Labs Llc Approved
Clozapine
ANDA #075417
Clozapine Tablet; Oral SUPPL-44 Mylan Labeling Approved
Clozapine
ANDA #075417
Clozapine Tablet; Oral SUPPL-47 Mylan Labeling Approved
Clozapine
ANDA #075417
Clozapine Tablet; Oral SUPPL-57 Mylan Labeling Approved
Clozapine
ANDA #075417
Clozapine Tablet; Oral SUPPL-59 Mylan Labeling Approved
Empagliflozin; Linagliptin; Metformin Hydrochloride
ANDA #215072
Empagliflozin;Linagliptin;Metformin Hydrochloride Tablet, Extended Release; Oral ORIG-1 Lupin Ltd Tentative Approval
Etodolac
ANDA #075419
Etodolac Capsule; Oral SUPPL-15 Apotex Labeling Approved
Etodolac
ANDA #075419
Etodolac Capsule; Oral SUPPL-15 Apotex Labeling Approved
Etodolac
ANDA #075419
Etodolac Capsule; Oral SUPPL-15 Apotex Labeling Approved
Flagyl
NDA #012623
Metronidazole Tablet; Oral SUPPL-72 Pfizer Labeling Approved
Flagyl
NDA #020334
Metronidazole Capsule; Oral SUPPL-15 Pfizer Labeling Approved
Flagyl Er
NDA #020868
Metronidazole Tablet, Extended Release; Oral SUPPL-17 Pfizer Labeling Approved
Flagyl I.V. Rtu In Plastic Container
NDA #018657
Metronidazole Injectable; Injection SUPPL-42 Baxter Hlthcare Labeling Approved
Gabapentin
ANDA #075428
Gabapentin Capsule; Oral SUPPL-5 Sandoz Labeling Approved
Gabapentin
ANDA #075428
Gabapentin Capsule; Oral SUPPL-4 Sandoz Labeling Approved
Gabapentin
ANDA #075428
Gabapentin Capsule; Oral SUPPL-5 Sandoz Labeling Approved
Gabapentin
ANDA #217965
Gabapentin Tablet; Oral SUPPL-1 Laurus Labeling Approved
Gabapentin
ANDA #217965
Gabapentin Tablet; Oral SUPPL-1 Laurus Labeling Approved
Gloperba
NDA #210942
Colchicine Solution; Oral SUPPL-2 Scilex Pharms Efficacy Tentative Approval
Helidac
NDA #050719
Bismuth Subsalicylate; Metronidazole; Tetracycline Hydrochloride Tablet, Chewable, Tablet, Capsule; Oral SUPPL-25 Casper Pharma Llc Labeling Approved
Isoflurane
ANDA #074502
Isoflurane Liquid; Inhalation SUPPL-26 Piramal Pharma Labeling Approved
Isoflurane
ANDA #074502
Isoflurane Liquid; Inhalation SUPPL-27 Piramal Pharma Labeling Approved
Isoflurane
ANDA #074502
Isoflurane Liquid; Inhalation SUPPL-28 Piramal Pharma Labeling Approved
L-Glutamine
ANDA #215647
L-Glutamine For Solution; Oral ORIG-1 Novitium Pharma Approved
Likmez
NDA #216755
Metronidazole Suspension; Oral SUPPL-3 Saptalis Pharms Labeling Approved
Likmez
NDA #216755
Metronidazole Suspension; Oral SUPPL-3 Saptalis Pharms Labeling Approved
Losartan Potassium
ANDA #078243
Losartan Potassium Tablet; Oral SUPPL-22 Zydus Pharms Usa Inc Labeling Approved
Losartan Potassium
ANDA #078243
Losartan Potassium Tablet; Oral SUPPL-22 Zydus Pharms Usa Inc Labeling Approved
Losartan Potassium
ANDA #078243
Losartan Potassium Tablet; Oral SUPPL-24 Zydus Pharms Usa Inc Labeling Approved
Losartan Potassium
ANDA #078243
Losartan Potassium Tablet; Oral SUPPL-28 Zydus Pharms Usa Inc Labeling Approved
Losartan Potassium
ANDA #078243
Losartan Potassium Tablet; Oral SUPPL-37 Zydus Pharms Usa Inc Labeling Approved
Losartan Potassium
ANDA #078243
Losartan Potassium Tablet; Oral SUPPL-28 Zydus Pharms Usa Inc Labeling Approved
Losartan Potassium
ANDA #078243
Losartan Potassium Tablet; Oral SUPPL-37 Zydus Pharms Usa Inc Labeling Approved
Metro I.V. In Plastic Container
NDA #018900
Metronidazole Injectable; Injection SUPPL-43 B Braun Labeling Approved
Metronidazole
NDA #018620
Metronidazole Tablet; Oral SUPPL-24 Fosun Pharma Labeling Approved
Metronidazole
NDA #018740
Metronidazole Tablet; Oral SUPPL-42 Fosun Pharma Labeling Approved
Metronidazole
NDA #018845
Metronidazole Tablet; Oral SUPPL-17 Chartwell Molecules Labeling Approved
Metronidazole
NDA #018907
Metronidazole Injectable; Injection SUPPL-8 Hikma Labeling Approved
Metronidazole
NDA #018930
Metronidazole Tablet; Oral SUPPL-16 Chartwell Molecules Labeling Approved
Metronidazole
ANDA #070027
Metronidazole Tablet; Oral SUPPL-53 Teva Pharms Usa Labeling Approved
Metronidazole
ANDA #070027
Metronidazole Tablet; Oral SUPPL-53 Teva Pharms Usa Labeling Approved
Metronidazole
ANDA #070033
Metronidazole Tablet; Oral SUPPL-54 Pliva Labeling Approved
Metronidazole
ANDA #070033
Metronidazole Tablet; Oral SUPPL-54 Pliva Labeling Approved
Metronidazole
ANDA #070035
Metronidazole Tablet; Oral SUPPL-63 Watson Labs Labeling Approved
Metronidazole
ANDA #070039
Metronidazole Tablet; Oral SUPPL-17 Strides Pharma Labeling Approved
Metronidazole
ANDA #070040
Metronidazole Tablet; Oral SUPPL-17 Strides Pharma Labeling Approved
Metronidazole
ANDA #070044
Metronidazole Tablet; Oral SUPPL-62 Watson Labs Inc Labeling Approved
Metronidazole
ANDA #070772
Metronidazole Tablet; Oral SUPPL-48 Innogenix Labeling Approved
Metronidazole
ANDA #079067
Metronidazole Tablet; Oral SUPPL-23 Alembic Pharms Ltd Labeling Approved
Metronidazole
ANDA #090222
Metronidazole Tablet, Extended Release; Oral SUPPL-5 Alembic Labeling Approved
Metronidazole
ANDA #090222
Metronidazole Tablet, Extended Release; Oral SUPPL-5 Alembic Labeling Approved
Metronidazole
ANDA #203458
Metronidazole Tablet; Oral SUPPL-22 Unichem Labeling Approved
Metronidazole
ANDA #203974
Metronidazole Tablet; Oral SUPPL-14 Aurobindo Pharma Ltd Labeling Approved
Metronidazole
ANDA #205245
Metronidazole Tablet; Oral SUPPL-12 Heritage Pharms Inc Labeling Approved
Metronidazole
ANDA #205245
Metronidazole Tablet; Oral SUPPL-12 Heritage Pharms Inc Labeling Approved
Metronidazole
ANDA #206560
Metronidazole Tablet; Oral SUPPL-9 Cadila Labeling Approved
Metronidazole
ANDA #208162
Metronidazole Tablet; Oral SUPPL-11 Strides Pharma Labeling Approved
Metronidazole
ANDA #208681
Metronidazole Tablet; Oral SUPPL-1 Alembic Labeling Approved
Metronidazole
ANDA #209096
Metronidazole Tablet; Oral SUPPL-5 Lupin Ltd Labeling Approved
Metronidazole
ANDA #209794
Metronidazole Tablet; Oral SUPPL-6 Cadila Pharms Ltd Labeling Approved
Metronidazole In Plastic Container
NDA #018890
Metronidazole Injectable; Injection SUPPL-57 Hospira Labeling Approved
Mucinex D
NDA #021585
Guaifenesin; Pseudoephedrine Hydrochloride Tablet, Extended Release; Oral SUPPL-38 Rb Hlth Labeling Approved
Mupirocin
ANDA #201587
Mupirocin Calcium Cream; Topical SUPPL-13 Glenmark Pharms Inc Labeling Approved
Mupirocin
ANDA #201587
Mupirocin Calcium Cream; Topical SUPPL-11 Glenmark Pharms Inc Labeling Approved
Mupirocin
ANDA #201587
Mupirocin Calcium Cream; Topical SUPPL-13 Glenmark Pharms Inc Labeling Approved
Mycophenolate Mofetil
ANDA #210181
Mycophenolate Mofetil Capsule; Oral SUPPL-18 Concord Biotech Ltd Labeling Approved
Mycophenolate Mofetil
ANDA #210181
Mycophenolate Mofetil Capsule; Oral SUPPL-18 Concord Biotech Ltd Labeling Approved
Mycophenolate Mofetil
ANDA #212087
Mycophenolate Mofetil Tablet; Oral SUPPL-11 Concord Biotech Ltd Labeling Approved
Mycophenolate Mofetil
ANDA #212087
Mycophenolate Mofetil Tablet; Oral SUPPL-11 Concord Biotech Ltd Labeling Approved
Mycophenolate Mofetil
ANDA #212087
Mycophenolate Mofetil Tablet; Oral SUPPL-11 Concord Biotech Ltd Labeling Approved
Ondansetron Hydrochloride Preservative Free
ANDA #202253
Ondansetron Hydrochloride Injectable; Injection SUPPL-12 Fresenius Kabi Usa Manufacturing (CMC) Approved
Ondansetron Hydrochloride Preservative Free
ANDA #202253
Ondansetron Hydrochloride Injectable; Injection SUPPL-8 Fresenius Kabi Usa Labeling Approved
Ondansetron Hydrochloride Preservative Free
ANDA #202253
Ondansetron Hydrochloride Injectable; Injection SUPPL-13 Fresenius Kabi Usa Labeling Approved
Ondansetron Hydrochloride Preservative Free
ANDA #202253
Ondansetron Hydrochloride Injectable; Injection SUPPL-12 Fresenius Kabi Usa Manufacturing (CMC) Approved
Paroxetine Hydrochloride
ANDA #075716
Paroxetine Hydrochloride Tablet; Oral SUPPL-13 Norvium Bioscience Labeling Approved
Paroxetine Hydrochloride
ANDA #077395
Paroxetine Hydrochloride Suspension; Oral SUPPL-15 Apotex Inc Labeling Approved
Paroxetine Hydrochloride
ANDA #077395
Paroxetine Hydrochloride Suspension; Oral SUPPL-15 Apotex Inc Labeling Approved
Pimtrea
ANDA #091247
Desogestrel; Ethinyl Estradiol Tablet; Oral-28 SUPPL-10 Novast Labs Labeling Approved
Pimtrea
ANDA #091247
Desogestrel; Ethinyl Estradiol Tablet; Oral-28 SUPPL-10 Novast Labs Labeling Approved
Piroxicam
ANDA #205585
Piroxicam Capsule; Oral SUPPL-2 Zydus Lifesciences Labeling Approved
Piroxicam
ANDA #205585
Piroxicam Capsule; Oral SUPPL-2 Zydus Lifesciences Labeling Approved
Pylera
NDA #050786
Bismuth Subcitrate Potassium; Metronidazole; Tetracycline Hydrochloride Capsule; Oral SUPPL-26 Labs Juvise Labeling Approved
Sildenafil Citrate
ANDA #212260
Sildenafil Citrate For Suspension; Oral SUPPL-15 Novitium Pharma Labeling Approved
Valproic Acid
ANDA #075379
Valproic Acid Syrup; Oral SUPPL-23 Pharm Assoc Labeling Approved
Valproic Acid
ANDA #075379
Valproic Acid Syrup; Oral SUPPL-23 Pharm Assoc Labeling Approved
Valproic Acid
ANDA #075379
Valproic Acid Syrup; Oral SUPPL-19 Pharm Assoc Labeling Approved
Valproic Acid
ANDA #075379
Valproic Acid Syrup; Oral SUPPL-23 Pharm Assoc Labeling Approved
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