Drugs@FDA: FDA Approved Drug Products
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.
January 22, 2019
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Abiraterone Acetate
ANDA #209227 |
Abiraterone Acetate | Unknown | ORIG-1 | Glenmark Pharms Sa | Tentative Approval | |
| Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate
ANDA #205401 |
Amphetamine Aspartate;Amphetamine Sulfate;Dextroamphetamine Saccharate;Dextroamphetamine Sulfate | Unknown | ORIG-1 | Amerigen Pharms Ltd | Approved | |
| Prandin
NDA #020741 |
Repaglinide | Tablet; Oral | SUPPL-44 | Gemini Labs Llc | Labeling | Approved |
| Revlimid
NDA #021880 |
Lenalidomide | Capsule; Oral | SUPPL-56 | Celgene | Labeling | Approved |
January 18, 2019
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Acyclovir
ANDA #211794 |
Acyclovir | Ointment; Topical | ORIG-1 | Cipla | Approved | |
| Carfilzomib
ANDA #209425 |
Carfilzomib | Unknown | ORIG-1 | Apotex Inc | Tentative Approval | |
| Carfilzomib
ANDA #209528 |
Carfilzomib | Unknown | ORIG-1 | Qilu Pharm Co Ltd | Tentative Approval | |
| Cyclophosphamide
ANDA #211608 |
Cyclophosphamide | Capsule; Oral | ORIG-1 | Cipla | Approved | |
| Dapagliflozin
ANDA #211439 |
Dapagliflozin | Unknown | ORIG-1 | Hetero Labs Unit Iii | Tentative Approval | |
| Dexmedetomidine Hydrochloride
ANDA #204843 |
Dexmedetomidine Hydrochloride | Injectable; Injection | ORIG-1 | Cipla | Approved | |
| Egrifta
NDA #022505 |
Tesamorelin Acetate | Powder; Subcutaneous | SUPPL-11 | Theratechnologies | Labeling | Approved |
| Entocort Ec
NDA #021324 |
Budesonide | Capsule; Oral | SUPPL-18 | Perrigo Pharma Intl | Labeling | Approved |
| Erivedge
NDA #203388 |
Vismodegib | Capsule; Oral | SUPPL-12 | Genentech | Efficacy | Approved |
| Esomeprazole Magnesium
ANDA #206296 |
Esomeprazole Magnesium | Unknown | ORIG-1 | Zydus Pharms Usa Inc | Tentative Approval | |
| Increlex
NDA #021839 |
Mecasermin Recombinant | Injectable; Subcutaneous | SUPPL-21 | Ipsen Inc | Labeling | Approved |
| Lansoprazole
ANDA #207394 |
Lansoprazole | Capsule, Delayed Rel Pellets; Oral | ORIG-1 | Alkem Labs Ltd | Approved | |
| Levothyroxine Sodium
ANDA #209713 |
Levothyroxine Sodium | Tablet; Oral | ORIG-1 | Lupin Atlantis | Approved | |
| Libtayo
BLA #761097 |
Cemiplimab-Rwlc | Injectable; Intravenous | SUPPL-2 | Regeneron Pharmaceuticals | Labeling | Approved |
| Methimazole
ANDA #040350 |
Methimazole | Tablet; Oral | SUPPL-23 | Mylan | Labeling | Approved |
| Methimazole
ANDA #040411 |
Methimazole | Tablet; Oral | SUPPL-28 | Casi Pharms Inc | Labeling | Approved |
| Methimazole
ANDA #040547 |
Methimazole | Tablet; Oral | SUPPL-11 | Eci Pharms Llc | Labeling | Approved |
| Methimazole
ANDA #040547 |
Methimazole | Tablet; Oral | SUPPL-11 | Eci Pharms Llc | Labeling | Approved |
| Methimazole
ANDA #040619 |
Methimazole | Tablet; Oral | SUPPL-4 | Eci Pharms Llc | Labeling | Approved |
| Methimazole
ANDA #040734 |
Methimazole | Tablet; Oral | SUPPL-7 | Heritage Pharma | Labeling | Approved |
| Methimazole
ANDA #040870 |
Methimazole | Tablet; Oral | SUPPL-8 | Sun Pharm Inds Inc | Labeling | Approved |
| Moxidectin
NDA #210867 |
Moxidectin | Tablet; Oral | SUPPL-1 | Mdgh | Labeling | Approved |
| Neupro
NDA #021829 |
Rotigotine | Film, Extended Release; Transdermal | SUPPL-16 | Ucb Inc | Labeling | Approved |
| Ontruzant
BLA #761100 |
Trastuzumab-Dttb | Injectable; Injection | ORIG-1 | Samsung Bioepis Co Ltd | Approved | |
| Retacrit
BLA #125545 |
Epoetin Alfa-Epbx | Injectable; Injection | SUPPL-3 | Hospira Inc | Labeling | Approved |
| Tapazole
ANDA #040320 |
Methimazole | Tablet; Oral | SUPPL-12 | King Pharms Llc | Labeling | Approved |
January 17, 2019
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Aldactazide
NDA #012616 |
Hydrochlorothiazide; Spironolactone | Tablet; Oral | SUPPL-78 | Gd Searle Llc | Labeling | Approved |
| Atorvastatin Calcium
ANDA #090548 |
Atorvastatin Calcium | Tablet; Oral | SUPPL-19 | Apotex Inc | Labeling | Approved |
| Atorvastatin Calcium
ANDA #090548 |
Atorvastatin Calcium | Tablet; Oral | SUPPL-19 | Apotex Inc | Labeling | Approved |
| Imatinib Mesylate
ANDA #208302 |
Imatinib Mesylate | Tablet; Oral | ORIG-1 | Shilpa Medicare Ltd | Approved | |
| Imatinib Mesylate
ANDA #208429 |
Imatinib Mesylate | Tablet; Oral | ORIG-1 | Wockhardt Bio Ag | Approved | |
| Levemir
NDA #021536 |
Insulin Detemir Recombinant | Injectable; Subcutaneous | SUPPL-54 | Novo Nordisk Inc | Labeling | Approved |
| Levemir
NDA #021536 |
Insulin Detemir Recombinant | Injectable; Subcutaneous | SUPPL-54 | Novo Nordisk Inc | Labeling | Approved |
| Levemir
NDA #021536 |
Insulin Detemir Recombinant | Injectable; Subcutaneous | SUPPL-54 | Novo Nordisk Inc | Labeling | Approved |
| Levemir Flexpen
NDA #021536 |
Insulin Detemir Recombinant | Injectable; Subcutaneous | SUPPL-54 | Novo Nordisk Inc | Labeling | Approved |
| Levemir Flexpen
NDA #021536 |
Insulin Detemir Recombinant | Injectable; Subcutaneous | SUPPL-54 | Novo Nordisk Inc | Labeling | Approved |
| Levemir Flexpen
NDA #021536 |
Insulin Detemir Recombinant | Injectable; Subcutaneous | SUPPL-54 | Novo Nordisk Inc | Labeling | Approved |
| Levemir Flextouch
NDA #021536 |
Insulin Detemir Recombinant | Injectable; Subcutaneous | SUPPL-54 | Novo Nordisk Inc | Labeling | Approved |
| Levemir Flextouch
NDA #021536 |
Insulin Detemir Recombinant | Injectable; Subcutaneous | SUPPL-54 | Novo Nordisk Inc | Labeling | Approved |
| Levemir Flextouch
NDA #021536 |
Insulin Detemir Recombinant | Injectable; Subcutaneous | SUPPL-54 | Novo Nordisk Inc | Labeling | Approved |
| Levemir Innolet
NDA #021536 |
Insulin Detemir Recombinant | Injectable; Subcutaneous | SUPPL-54 | Novo Nordisk Inc | Labeling | Approved |
| Levemir Innolet
NDA #021536 |
Insulin Detemir Recombinant | Injectable; Subcutaneous | SUPPL-54 | Novo Nordisk Inc | Labeling | Approved |
| Levemir Innolet
NDA #021536 |
Insulin Detemir Recombinant | Injectable; Subcutaneous | SUPPL-54 | Novo Nordisk Inc | Labeling | Approved |
| Levemir Penfill
NDA #021536 |
Insulin Detemir Recombinant | Injectable; Subcutaneous | SUPPL-54 | Novo Nordisk Inc | Labeling | Approved |
| Levemir Penfill
NDA #021536 |
Insulin Detemir Recombinant | Injectable; Subcutaneous | SUPPL-54 | Novo Nordisk Inc | Labeling | Approved |
| Levemir Penfill
NDA #021536 |
Insulin Detemir Recombinant | Injectable; Subcutaneous | SUPPL-54 | Novo Nordisk Inc | Labeling | Approved |
| Revatio
NDA #022473 |
Sildenafil Citrate | Solution; Intravenous | SUPPL-12 | Pfizer | Labeling | Approved |
| Revatio
NDA #203109 |
Sildenafil Citrate | For Suspension; Oral | SUPPL-12 | Pfizer | Labeling | Approved |
January 16, 2019
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Acetazolamide
ANDA #205301 |
Acetazolamide | Capsule, Extended Release; Oral | ORIG-1 | Xylopia | Approved | |
| Campath
BLA #103948 |
Alemtuzumab | Vial; Intravenous | SUPPL-5163 | Genzyme | Labeling | Approved |
| Campath
BLA #103948 |
Alemtuzumab | Vial; Intravenous | SUPPL-5164 | Genzyme | Labeling | Approved |
| Campath
BLA #103948 |
Alemtuzumab | Vial; Intravenous | SUPPL-5163 | Genzyme | Labeling | Approved |
| Campath
BLA #103948 |
Alemtuzumab | Vial; Intravenous | SUPPL-5164 | Genzyme | Labeling | Approved |
| Capastat Sulfate
NDA #050095 |
Capreomycin Sulfate | Injectable; Injection | SUPPL-72 | Akorn | Labeling | Approved |
| Clozapine
ANDA #074949 |
Clozapine | Tablet; Oral | SUPPL-75 | Ivax Sub Teva Pharms | REMS | Approved |
| Clozapine
ANDA #075417 |
Clozapine | Tablet; Oral | SUPPL-41 | Mylan | REMS | Approved |
| Clozapine
ANDA #075713 |
Clozapine | Tablet; Oral | SUPPL-45 | Sun Pharm Inds Inc | REMS | Approved |
| Clozapine
ANDA #076809 |
Clozapine | Tablet; Oral | SUPPL-38 | Ivax Sub Teva Pharms | REMS | Approved |
| Clozapine
ANDA #090308 |
Clozapine | Tablet, Orally Disintegrating; Oral | SUPPL-3 | Barr Labs Inc | REMS | Approved |
| Clozapine
ANDA #201824 |
Clozapine | Tablet, Orally Disintegrating; Oral | SUPPL-9 | Mylan Pharms Inc | REMS | Approved |
| Clozapine
ANDA #202873 |
Clozapine | Tablet; Oral | SUPPL-5 | Accord Hlthcare | REMS | Approved |
| Clozapine
ANDA #203039 |
Clozapine | Tablet, Orally Disintegrating; Oral | SUPPL-5 | Teva Pharms Usa | REMS | Approved |
| Clozapine
ANDA #203807 |
Clozapine | Tablet; Oral | SUPPL-6 | Mayne Pharma | REMS | Approved |
| Clozapine
ANDA #206433 |
Clozapine | Tablet; Oral | SUPPL-4 | Aurobindo Pharma Ltd | REMS | Approved |
| Clozaril
NDA #019758 |
Clozapine | Tablet; Oral | SUPPL-90 | Heritage Life | REMS | Approved |
| Fazaclo Odt
NDA #021590 |
Clozapine | Tablet, Orally Disintegrating; Oral | SUPPL-31 | Jazz Pharms Iii | REMS | Approved |
| Isosulfan Blue
ANDA #210714 |
Isosulfan Blue | Injectable; Injection | ORIG-1 | Beloteca Inc | Approved | |
| Lemtrada
BLA #103948 |
Alemtuzumab | Injectable; Injection | SUPPL-5163 | Genzyme | Labeling | Approved |
| Lemtrada
BLA #103948 |
Alemtuzumab | Injectable; Injection | SUPPL-5164 | Genzyme | Labeling | Approved |
| Lemtrada
BLA #103948 |
Alemtuzumab | Injectable; Injection | SUPPL-5163 | Genzyme | Labeling | Approved |
| Lemtrada
BLA #103948 |
Alemtuzumab | Injectable; Injection | SUPPL-5164 | Genzyme | Labeling | Approved |
| Lioresal
NDA #020075 |
Baclofen | Injectable; Intrathecal | SUPPL-37 | Saol Theraps Res Ltd | Labeling | Approved |
| Prasugrel
ANDA #206021 |
Prasugrel Hydrochloride | Tablet; Oral | ORIG-1 | Hec Pharm | Approved | |
| Prevantics Maxi Swabstick
NDA #021524 |
Chlorhexidine Gluconate; Isopropyl Alcohol | Swab; Topical | SUPPL-20 | Prof Dspls | Labeling | Approved |
| Prevantics Swab
NDA #021524 |
Chlorhexidine Gluconate; Isopropyl Alcohol | Swab; Topical | SUPPL-20 | Prof Dspls | Labeling | Approved |
| Prevantics Swabstick
NDA #021524 |
Chlorhexidine Gluconate; Isopropyl Alcohol | Swab; Topical | SUPPL-20 | Prof Dspls | Labeling | Approved |
| Trientine Hydrochloride
ANDA #211251 |
Trientine Hydrochloride | Capsule; Oral | ORIG-1 | Navinta Llc | Approved | |
| Tylenol
NDA #019872 |
Acetaminophen | Tablet, Extended Release; Oral | SUPPL-48 | J and J Consumer Inc | Labeling | Approved |
| Versacloz
NDA #203479 |
Clozapine | Suspension; Oral | SUPPL-11 | Tasman Pharma | REMS | Approved |
| Welchol
NDA #021176 |
Colesevelam Hydrochloride | Tablet; Oral | SUPPL-44 | Daiichi Sankyo | Labeling | Approved |
| Welchol
NDA #022362 |
Colesevelam Hydrochloride | For Suspension; Oral | SUPPL-23 | Daiichi Sankyo | Labeling | Approved |
January 15, 2019
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Alendronate Sodium
ANDA #076768 |
Alendronate Sodium | Tablet; Oral | SUPPL-7 | Cipla | Labeling | Approved |
| Cytarabine
ANDA #071868 |
Cytarabine | Injectable; Injection | SUPPL-31 | Hospira | Labeling | Approved |
| Cytarabine
ANDA #071868 |
Cytarabine | Injectable; Injection | SUPPL-29 | Hospira | Labeling | Approved |
| Cytarabine
ANDA #071868 |
Cytarabine | Injectable; Injection | SUPPL-30 | Hospira | Labeling | Approved |
| Cytarabine
ANDA #072168 |
Cytarabine | Injectable; Injection | SUPPL-29 | Hospira | Labeling | Approved |
| Cytarabine
ANDA #072168 |
Cytarabine | Injectable; Injection | SUPPL-28 | Hospira | Labeling | Approved |
| Cytarabine
ANDA #072945 |
Cytarabine | Injectable; Injection | SUPPL-24 | Hospira | Labeling | Approved |
| Cytarabine
ANDA #075383 |
Cytarabine | Injectable; Injection | SUPPL-17 | Hospira | Labeling | Approved |
| Dexedrine
NDA #017078 |
Dextroamphetamine Sulfate | Capsule, Extended Release; Oral | SUPPL-52 | Impax Labs Inc | Labeling | Approved |
| Eletriptan Hydrobromide
ANDA #210708 |
Eletriptan Hydrobromide | Tablet; Oral | ORIG-1 | Aurobindo Pharma Ltd | Approved | |
| Hydroxychloroquine Sulfate
ANDA #210959 |
Hydroxychloroquine Sulfate | Tablet; Oral | ORIG-1 | Rising Pharms | Approved | |
| Polocaine
ANDA #088653 |
Mepivacaine Hydrochloride | Injectable; Injection | SUPPL-12 | Dentsply Pharm | Labeling | Approved |
| Polocaine W/ Levonordefrin
ANDA #089517 |
Levonordefrin; Mepivacaine Hydrochloride | Injectable; Injection | SUPPL-6 | Dentsply Pharm | Labeling | Approved |
| Rufinamide
ANDA #207363 |
Rufinamide | Unknown | ORIG-1 | West-Ward Pharms Int | Tentative Approval | |
| Sudafed 12 Hour
ANDA #073585 |
Pseudoephedrine Hydrochloride | Tablet, Extended Release; Oral | SUPPL-20 | Mcneil Cons | Labeling | Approved |
| Trulicity
BLA #125469 |
Dulaglutide | Injectable; Injection | SUPPL-23 | Eli Lilly and Co | Efficacy | Approved |
| Xarelto
NDA #022406 |
Rivaroxaban | Tablet; Oral | SUPPL-30 | Janssen Pharms | Labeling | Approved |
| Xarelto
NDA #022406 |
Rivaroxaban | Tablet; Oral | SUPPL-32 | Janssen Pharms | Labeling | Approved |
| Zegerid Otc
NDA #022281 |
Omeprazole; Sodium Bicarbonate | Capsule; Oral | SUPPL-13 | Bayer Healthcare Llc | Labeling | Approved |
| Zegerid Otc
NDA #022283 |
Omeprazole; Sodium Bicarbonate | For Suspension; Oral | SUPPL-3 | Bayer Healthcare Llc | Labeling | Approved |
| Zegerid Otc
NDA #022283 |
Omeprazole; Sodium Bicarbonate | For Suspension; Oral | SUPPL-3 | Bayer Healthcare Llc | Labeling | Approved |
January 14, 2019
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Alosetron Hydrochloride
ANDA #209180 |
Alosetron Hydrochloride | Tablet; Oral | ORIG-1 | Cipla | Approved | |
| Busulfan
ANDA #207794 |
Busulfan | Injectable; Injection | ORIG-1 | Nexus Pharms | Approved | |
| Cabometyx
NDA #208692 |
Cabozantinib S-Malate | Tablet; Oral | SUPPL-3 | Exelixis Inc | Efficacy | Approved |
| Hydrochlorothiazide
ANDA #203561 |
Hydrochlorothiazide | Capsule; Oral | ORIG-1 | Sciegen Pharms Inc | Approved | |
| Metformin Hydrochloride
ANDA #075973 |
Metformin Hydrochloride | Tablet; Oral | SUPPL-19 | Mylan | Labeling | Approved |
| Metformin Hydrochloride
ANDA #075973 |
Metformin Hydrochloride | Tablet; Oral | SUPPL-20 | Mylan | Labeling | Approved |
| Metformin Hydrochloride
ANDA #075973 |
Metformin Hydrochloride | Tablet; Oral | SUPPL-20 | Mylan | Labeling | Approved |
| Metformin Hydrochloride
ANDA #209313 |
Metformin Hydrochloride | Tablet, Extended Release; Oral | SUPPL-1 | Granules India Ltd | Labeling | Approved |
| Pioglitazone Hydrochloride
ANDA #078670 |
Pioglitazone Hydrochloride | Tablet; Oral | SUPPL-4 | Sandoz | Labeling | Approved |
| Pioglitazone Hydrochloride
ANDA #078670 |
Pioglitazone Hydrochloride | Tablet; Oral | SUPPL-4 | Sandoz | Labeling | Approved |
| Pioglitazone Hydrochloride
ANDA #078670 |
Pioglitazone Hydrochloride | Tablet; Oral | SUPPL-5 | Sandoz | Labeling | Approved |
| Vigabatrin
ANDA #209822 |
Vigabatrin | Tablet; Oral | ORIG-1 | Teva Pharms Usa | Approved |
January 22, 2019
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Abiraterone Acetate
ANDA #209227 |
Abiraterone Acetate | Unknown | ORIG-1 | Glenmark Pharms Sa | Tentative Approval | |
| Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate
ANDA #205401 |
Amphetamine Aspartate;Amphetamine Sulfate;Dextroamphetamine Saccharate;Dextroamphetamine Sulfate | Unknown | ORIG-1 | Amerigen Pharms Ltd | Approved | |
| Prandin
NDA #020741 |
Repaglinide | Tablet; Oral | SUPPL-44 | Gemini Labs Llc | Labeling | Approved |
| Revlimid
NDA #021880 |
Lenalidomide | Capsule; Oral | SUPPL-56 | Celgene | Labeling | Approved |
January 18, 2019
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Acyclovir
ANDA #211794 |
Acyclovir | Ointment; Topical | ORIG-1 | Cipla | Approved | |
| Carfilzomib
ANDA #209425 |
Carfilzomib | Unknown | ORIG-1 | Apotex Inc | Tentative Approval | |
| Carfilzomib
ANDA #209528 |
Carfilzomib | Unknown | ORIG-1 | Qilu Pharm Co Ltd | Tentative Approval | |
| Cyclophosphamide
ANDA #211608 |
Cyclophosphamide | Capsule; Oral | ORIG-1 | Cipla | Approved | |
| Dapagliflozin
ANDA #211439 |
Dapagliflozin | Unknown | ORIG-1 | Hetero Labs Unit Iii | Tentative Approval | |
| Dexmedetomidine Hydrochloride
ANDA #204843 |
Dexmedetomidine Hydrochloride | Injectable; Injection | ORIG-1 | Cipla | Approved | |
| Egrifta
NDA #022505 |
Tesamorelin Acetate | Powder; Subcutaneous | SUPPL-11 | Theratechnologies | Labeling | Approved |
| Entocort Ec
NDA #021324 |
Budesonide | Capsule; Oral | SUPPL-18 | Perrigo Pharma Intl | Labeling | Approved |
| Erivedge
NDA #203388 |
Vismodegib | Capsule; Oral | SUPPL-12 | Genentech | Efficacy | Approved |
| Esomeprazole Magnesium
ANDA #206296 |
Esomeprazole Magnesium | Unknown | ORIG-1 | Zydus Pharms Usa Inc | Tentative Approval | |
| Increlex
NDA #021839 |
Mecasermin Recombinant | Injectable; Subcutaneous | SUPPL-21 | Ipsen Inc | Labeling | Approved |
| Lansoprazole
ANDA #207394 |
Lansoprazole | Capsule, Delayed Rel Pellets; Oral | ORIG-1 | Alkem Labs Ltd | Approved | |
| Levothyroxine Sodium
ANDA #209713 |
Levothyroxine Sodium | Tablet; Oral | ORIG-1 | Lupin Atlantis | Approved | |
| Libtayo
BLA #761097 |
Cemiplimab-Rwlc | Injectable; Intravenous | SUPPL-2 | Regeneron Pharmaceuticals | Labeling | Approved |
| Methimazole
ANDA #040350 |
Methimazole | Tablet; Oral | SUPPL-23 | Mylan | Labeling | Approved |
| Methimazole
ANDA #040411 |
Methimazole | Tablet; Oral | SUPPL-28 | Casi Pharms Inc | Labeling | Approved |
| Methimazole
ANDA #040547 |
Methimazole | Tablet; Oral | SUPPL-11 | Eci Pharms Llc | Labeling | Approved |
| Methimazole
ANDA #040547 |
Methimazole | Tablet; Oral | SUPPL-11 | Eci Pharms Llc | Labeling | Approved |
| Methimazole
ANDA #040619 |
Methimazole | Tablet; Oral | SUPPL-4 | Eci Pharms Llc | Labeling | Approved |
| Methimazole
ANDA #040734 |
Methimazole | Tablet; Oral | SUPPL-7 | Heritage Pharma | Labeling | Approved |
| Methimazole
ANDA #040870 |
Methimazole | Tablet; Oral | SUPPL-8 | Sun Pharm Inds Inc | Labeling | Approved |
| Moxidectin
NDA #210867 |
Moxidectin | Tablet; Oral | SUPPL-1 | Mdgh | Labeling | Approved |
| Neupro
NDA #021829 |
Rotigotine | Film, Extended Release; Transdermal | SUPPL-16 | Ucb Inc | Labeling | Approved |
| Ontruzant
BLA #761100 |
Trastuzumab-Dttb | Injectable; Injection | ORIG-1 | Samsung Bioepis Co Ltd | Approved | |
| Retacrit
BLA #125545 |
Epoetin Alfa-Epbx | Injectable; Injection | SUPPL-3 | Hospira Inc | Labeling | Approved |
| Tapazole
ANDA #040320 |
Methimazole | Tablet; Oral | SUPPL-12 | King Pharms Llc | Labeling | Approved |
January 17, 2019
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Aldactazide
NDA #012616 |
Hydrochlorothiazide; Spironolactone | Tablet; Oral | SUPPL-78 | Gd Searle Llc | Labeling | Approved |
| Atorvastatin Calcium
ANDA #090548 |
Atorvastatin Calcium | Tablet; Oral | SUPPL-19 | Apotex Inc | Labeling | Approved |
| Atorvastatin Calcium
ANDA #090548 |
Atorvastatin Calcium | Tablet; Oral | SUPPL-19 | Apotex Inc | Labeling | Approved |
| Imatinib Mesylate
ANDA #208302 |
Imatinib Mesylate | Tablet; Oral | ORIG-1 | Shilpa Medicare Ltd | Approved | |
| Imatinib Mesylate
ANDA #208429 |
Imatinib Mesylate | Tablet; Oral | ORIG-1 | Wockhardt Bio Ag | Approved | |
| Levemir
NDA #021536 |
Insulin Detemir Recombinant | Injectable; Subcutaneous | SUPPL-54 | Novo Nordisk Inc | Labeling | Approved |
| Levemir
NDA #021536 |
Insulin Detemir Recombinant | Injectable; Subcutaneous | SUPPL-54 | Novo Nordisk Inc | Labeling | Approved |
| Levemir
NDA #021536 |
Insulin Detemir Recombinant | Injectable; Subcutaneous | SUPPL-54 | Novo Nordisk Inc | Labeling | Approved |
| Levemir Flexpen
NDA #021536 |
Insulin Detemir Recombinant | Injectable; Subcutaneous | SUPPL-54 | Novo Nordisk Inc | Labeling | Approved |
| Levemir Flexpen
NDA #021536 |
Insulin Detemir Recombinant | Injectable; Subcutaneous | SUPPL-54 | Novo Nordisk Inc | Labeling | Approved |
| Levemir Flexpen
NDA #021536 |
Insulin Detemir Recombinant | Injectable; Subcutaneous | SUPPL-54 | Novo Nordisk Inc | Labeling | Approved |
| Levemir Flextouch
NDA #021536 |
Insulin Detemir Recombinant | Injectable; Subcutaneous | SUPPL-54 | Novo Nordisk Inc | Labeling | Approved |
| Levemir Flextouch
NDA #021536 |
Insulin Detemir Recombinant | Injectable; Subcutaneous | SUPPL-54 | Novo Nordisk Inc | Labeling | Approved |
| Levemir Flextouch
NDA #021536 |
Insulin Detemir Recombinant | Injectable; Subcutaneous | SUPPL-54 | Novo Nordisk Inc | Labeling | Approved |
| Levemir Innolet
NDA #021536 |
Insulin Detemir Recombinant | Injectable; Subcutaneous | SUPPL-54 | Novo Nordisk Inc | Labeling | Approved |
| Levemir Innolet
NDA #021536 |
Insulin Detemir Recombinant | Injectable; Subcutaneous | SUPPL-54 | Novo Nordisk Inc | Labeling | Approved |
| Levemir Innolet
NDA #021536 |
Insulin Detemir Recombinant | Injectable; Subcutaneous | SUPPL-54 | Novo Nordisk Inc | Labeling | Approved |
| Levemir Penfill
NDA #021536 |
Insulin Detemir Recombinant | Injectable; Subcutaneous | SUPPL-54 | Novo Nordisk Inc | Labeling | Approved |
| Levemir Penfill
NDA #021536 |
Insulin Detemir Recombinant | Injectable; Subcutaneous | SUPPL-54 | Novo Nordisk Inc | Labeling | Approved |
| Levemir Penfill
NDA #021536 |
Insulin Detemir Recombinant | Injectable; Subcutaneous | SUPPL-54 | Novo Nordisk Inc | Labeling | Approved |
| Revatio
NDA #022473 |
Sildenafil Citrate | Solution; Intravenous | SUPPL-12 | Pfizer | Labeling | Approved |
| Revatio
NDA #203109 |
Sildenafil Citrate | For Suspension; Oral | SUPPL-12 | Pfizer | Labeling | Approved |
January 16, 2019
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Acetazolamide
ANDA #205301 |
Acetazolamide | Capsule, Extended Release; Oral | ORIG-1 | Xylopia | Approved | |
| Campath
BLA #103948 |
Alemtuzumab | Vial; Intravenous | SUPPL-5163 | Genzyme | Labeling | Approved |
| Campath
BLA #103948 |
Alemtuzumab | Vial; Intravenous | SUPPL-5164 | Genzyme | Labeling | Approved |
| Campath
BLA #103948 |
Alemtuzumab | Vial; Intravenous | SUPPL-5163 | Genzyme | Labeling | Approved |
| Campath
BLA #103948 |
Alemtuzumab | Vial; Intravenous | SUPPL-5164 | Genzyme | Labeling | Approved |
| Capastat Sulfate
NDA #050095 |
Capreomycin Sulfate | Injectable; Injection | SUPPL-72 | Akorn | Labeling | Approved |
| Clozapine
ANDA #074949 |
Clozapine | Tablet; Oral | SUPPL-75 | Ivax Sub Teva Pharms | REMS | Approved |
| Clozapine
ANDA #075417 |
Clozapine | Tablet; Oral | SUPPL-41 | Mylan | REMS | Approved |
| Clozapine
ANDA #075713 |
Clozapine | Tablet; Oral | SUPPL-45 | Sun Pharm Inds Inc | REMS | Approved |
| Clozapine
ANDA #076809 |
Clozapine | Tablet; Oral | SUPPL-38 | Ivax Sub Teva Pharms | REMS | Approved |
| Clozapine
ANDA #090308 |
Clozapine | Tablet, Orally Disintegrating; Oral | SUPPL-3 | Barr Labs Inc | REMS | Approved |
| Clozapine
ANDA #201824 |
Clozapine | Tablet, Orally Disintegrating; Oral | SUPPL-9 | Mylan Pharms Inc | REMS | Approved |
| Clozapine
ANDA #202873 |
Clozapine | Tablet; Oral | SUPPL-5 | Accord Hlthcare | REMS | Approved |
| Clozapine
ANDA #203039 |
Clozapine | Tablet, Orally Disintegrating; Oral | SUPPL-5 | Teva Pharms Usa | REMS | Approved |
| Clozapine
ANDA #203807 |
Clozapine | Tablet; Oral | SUPPL-6 | Mayne Pharma | REMS | Approved |
| Clozapine
ANDA #206433 |
Clozapine | Tablet; Oral | SUPPL-4 | Aurobindo Pharma Ltd | REMS | Approved |
| Clozaril
NDA #019758 |
Clozapine | Tablet; Oral | SUPPL-90 | Heritage Life | REMS | Approved |
| Fazaclo Odt
NDA #021590 |
Clozapine | Tablet, Orally Disintegrating; Oral | SUPPL-31 | Jazz Pharms Iii | REMS | Approved |
| Isosulfan Blue
ANDA #210714 |
Isosulfan Blue | Injectable; Injection | ORIG-1 | Beloteca Inc | Approved | |
| Lemtrada
BLA #103948 |
Alemtuzumab | Injectable; Injection | SUPPL-5163 | Genzyme | Labeling | Approved |
| Lemtrada
BLA #103948 |
Alemtuzumab | Injectable; Injection | SUPPL-5164 | Genzyme | Labeling | Approved |
| Lemtrada
BLA #103948 |
Alemtuzumab | Injectable; Injection | SUPPL-5163 | Genzyme | Labeling | Approved |
| Lemtrada
BLA #103948 |
Alemtuzumab | Injectable; Injection | SUPPL-5164 | Genzyme | Labeling | Approved |
| Lioresal
NDA #020075 |
Baclofen | Injectable; Intrathecal | SUPPL-37 | Saol Theraps Res Ltd | Labeling | Approved |
| Prasugrel
ANDA #206021 |
Prasugrel Hydrochloride | Tablet; Oral | ORIG-1 | Hec Pharm | Approved | |
| Prevantics Maxi Swabstick
NDA #021524 |
Chlorhexidine Gluconate; Isopropyl Alcohol | Swab; Topical | SUPPL-20 | Prof Dspls | Labeling | Approved |
| Prevantics Swab
NDA #021524 |
Chlorhexidine Gluconate; Isopropyl Alcohol | Swab; Topical | SUPPL-20 | Prof Dspls | Labeling | Approved |
| Prevantics Swabstick
NDA #021524 |
Chlorhexidine Gluconate; Isopropyl Alcohol | Swab; Topical | SUPPL-20 | Prof Dspls | Labeling | Approved |
| Trientine Hydrochloride
ANDA #211251 |
Trientine Hydrochloride | Capsule; Oral | ORIG-1 | Navinta Llc | Approved | |
| Tylenol
NDA #019872 |
Acetaminophen | Tablet, Extended Release; Oral | SUPPL-48 | J and J Consumer Inc | Labeling | Approved |
| Versacloz
NDA #203479 |
Clozapine | Suspension; Oral | SUPPL-11 | Tasman Pharma | REMS | Approved |
| Welchol
NDA #021176 |
Colesevelam Hydrochloride | Tablet; Oral | SUPPL-44 | Daiichi Sankyo | Labeling | Approved |
| Welchol
NDA #022362 |
Colesevelam Hydrochloride | For Suspension; Oral | SUPPL-23 | Daiichi Sankyo | Labeling | Approved |
January 15, 2019
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Alendronate Sodium
ANDA #076768 |
Alendronate Sodium | Tablet; Oral | SUPPL-7 | Cipla | Labeling | Approved |
| Cytarabine
ANDA #071868 |
Cytarabine | Injectable; Injection | SUPPL-31 | Hospira | Labeling | Approved |
| Cytarabine
ANDA #071868 |
Cytarabine | Injectable; Injection | SUPPL-29 | Hospira | Labeling | Approved |
| Cytarabine
ANDA #071868 |
Cytarabine | Injectable; Injection | SUPPL-30 | Hospira | Labeling | Approved |
| Cytarabine
ANDA #072168 |
Cytarabine | Injectable; Injection | SUPPL-29 | Hospira | Labeling | Approved |
| Cytarabine
ANDA #072168 |
Cytarabine | Injectable; Injection | SUPPL-28 | Hospira | Labeling | Approved |
| Cytarabine
ANDA #072945 |
Cytarabine | Injectable; Injection | SUPPL-24 | Hospira | Labeling | Approved |
| Cytarabine
ANDA #075383 |
Cytarabine | Injectable; Injection | SUPPL-17 | Hospira | Labeling | Approved |
| Dexedrine
NDA #017078 |
Dextroamphetamine Sulfate | Capsule, Extended Release; Oral | SUPPL-52 | Impax Labs Inc | Labeling | Approved |
| Eletriptan Hydrobromide
ANDA #210708 |
Eletriptan Hydrobromide | Tablet; Oral | ORIG-1 | Aurobindo Pharma Ltd | Approved | |
| Hydroxychloroquine Sulfate
ANDA #210959 |
Hydroxychloroquine Sulfate | Tablet; Oral | ORIG-1 | Rising Pharms | Approved | |
| Polocaine
ANDA #088653 |
Mepivacaine Hydrochloride | Injectable; Injection | SUPPL-12 | Dentsply Pharm | Labeling | Approved |
| Polocaine W/ Levonordefrin
ANDA #089517 |
Levonordefrin; Mepivacaine Hydrochloride | Injectable; Injection | SUPPL-6 | Dentsply Pharm | Labeling | Approved |
| Rufinamide
ANDA #207363 |
Rufinamide | Unknown | ORIG-1 | West-Ward Pharms Int | Tentative Approval | |
| Sudafed 12 Hour
ANDA #073585 |
Pseudoephedrine Hydrochloride | Tablet, Extended Release; Oral | SUPPL-20 | Mcneil Cons | Labeling | Approved |
| Trulicity
BLA #125469 |
Dulaglutide | Injectable; Injection | SUPPL-23 | Eli Lilly and Co | Efficacy | Approved |
| Xarelto
NDA #022406 |
Rivaroxaban | Tablet; Oral | SUPPL-30 | Janssen Pharms | Labeling | Approved |
| Xarelto
NDA #022406 |
Rivaroxaban | Tablet; Oral | SUPPL-32 | Janssen Pharms | Labeling | Approved |
| Zegerid Otc
NDA #022281 |
Omeprazole; Sodium Bicarbonate | Capsule; Oral | SUPPL-13 | Bayer Healthcare Llc | Labeling | Approved |
| Zegerid Otc
NDA #022283 |
Omeprazole; Sodium Bicarbonate | For Suspension; Oral | SUPPL-3 | Bayer Healthcare Llc | Labeling | Approved |
| Zegerid Otc
NDA #022283 |
Omeprazole; Sodium Bicarbonate | For Suspension; Oral | SUPPL-3 | Bayer Healthcare Llc | Labeling | Approved |
January 14, 2019
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Alosetron Hydrochloride
ANDA #209180 |
Alosetron Hydrochloride | Tablet; Oral | ORIG-1 | Cipla | Approved | |
| Busulfan
ANDA #207794 |
Busulfan | Injectable; Injection | ORIG-1 | Nexus Pharms | Approved | |
| Cabometyx
NDA #208692 |
Cabozantinib S-Malate | Tablet; Oral | SUPPL-3 | Exelixis Inc | Efficacy | Approved |
| Hydrochlorothiazide
ANDA #203561 |
Hydrochlorothiazide | Capsule; Oral | ORIG-1 | Sciegen Pharms Inc | Approved | |
| Metformin Hydrochloride
ANDA #075973 |
Metformin Hydrochloride | Tablet; Oral | SUPPL-19 | Mylan | Labeling | Approved |
| Metformin Hydrochloride
ANDA #075973 |
Metformin Hydrochloride | Tablet; Oral | SUPPL-20 | Mylan | Labeling | Approved |
| Metformin Hydrochloride
ANDA #075973 |
Metformin Hydrochloride | Tablet; Oral | SUPPL-20 | Mylan | Labeling | Approved |
| Metformin Hydrochloride
ANDA #209313 |
Metformin Hydrochloride | Tablet, Extended Release; Oral | SUPPL-1 | Granules India Ltd | Labeling | Approved |
| Pioglitazone Hydrochloride
ANDA #078670 |
Pioglitazone Hydrochloride | Tablet; Oral | SUPPL-4 | Sandoz | Labeling | Approved |
| Pioglitazone Hydrochloride
ANDA #078670 |
Pioglitazone Hydrochloride | Tablet; Oral | SUPPL-4 | Sandoz | Labeling | Approved |
| Pioglitazone Hydrochloride
ANDA #078670 |
Pioglitazone Hydrochloride | Tablet; Oral | SUPPL-5 | Sandoz | Labeling | Approved |
| Vigabatrin
ANDA #209822 |
Vigabatrin | Tablet; Oral | ORIG-1 | Teva Pharms Usa | Approved |
January 11, 2019
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Acyclovir
ANDA #209971 |
Acyclovir | Ointment; Topical | ORIG-1 | Torrent Pharms Ltd | Approved | |
| Amlodipine Besylate and Atorvastatin Calcium
ANDA #207762 |
Amlodipine Besylate; Atorvastatin Calcium | Tablet; Oral | ORIG-1 | Zydus Pharms Usa Inc | Approved | |
| Betamethasone Dipropionate
ANDA #208885 |
Betamethasone Dipropionate | Cream; Topical | ORIG-1 | Zydus Pharms Usa Inc | Approved | |
| Celexa
NDA #020822 |
Citalopram Hydrobromide | Tablet; Oral | SUPPL-51 | Allergan Sales Llc | Labeling | Approved |
| Clobetasol Propionate
ANDA #211401 |
Clobetasol Propionate | Cream; Topical | ORIG-1 | Solaris Pharma Corp | Approved | |
| Gilenya
NDA #022527 |
Fingolimod Hydrochloride | Capsule; Oral | SUPPL-26 | Novartis | Labeling | Approved |
| Humira
BLA #125057 |
Adalimumab | Syringe | SUPPL-411 | Abbvie Inc | Labeling | Approved |
| Humira
BLA #125057 |
Adalimumab | Vial | SUPPL-411 | Abbvie Inc | Labeling | Approved |
| Letrozole
ANDA #211717 |
Letrozole | Tablet; Oral | ORIG-1 | Eugia Pharma | Approved | |
| Lexapro
NDA #021323 |
Escitalopram Oxalate | Tablet; Oral | SUPPL-51 | Allergan Sales Llc | Labeling | Approved |
| Lexapro
NDA #021365 |
Escitalopram Oxalate | Solution; Oral | SUPPL-36 | Allergan Sales Llc | Labeling | Approved |
| Lisinopril
ANDA #075994 |
Lisinopril | Tablet; Oral | SUPPL-53 | Casi Pharms Inc | Labeling | Approved |
| Lisinopril
ANDA #075994 |
Lisinopril | Tablet; Oral | SUPPL-56 | Casi Pharms Inc | Labeling | Approved |
| Mycophenolate Mofetil
ANDA #203005 |
Mycophenolate Mofetil | Suspension; Oral | SUPPL-4 | Alkem Labs Ltd | Labeling | Approved |
| Mycophenolate Mofetil
ANDA #203005 |
Mycophenolate Mofetil | Suspension; Oral | SUPPL-6 | Alkem Labs Ltd | Labeling | Approved |
| Mycophenolate Mofetil
ANDA #203005 |
Mycophenolate Mofetil | Suspension; Oral | SUPPL-7 | Alkem Labs Ltd | Labeling | Approved |
| Mycophenolate Mofetil
ANDA #203005 |
Mycophenolate Mofetil | Suspension; Oral | SUPPL-6 | Alkem Labs Ltd | Labeling | Approved |
| Nalbuphine Hydrochloride
ANDA #207595 |
Nalbuphine Hydrochloride | Injectable; Injection | ORIG-1 | Mylan Labs Ltd | Approved | |
| Potassium Chloride 0.15% In Sodium Chloride 0.45% In Plastic Container
NDA #017648 |
Potassium Chloride; Sodium Chloride | Injectable; Injection | SUPPL-71 | Baxter Hlthcare | Labeling | Approved |
| Potassium Chloride 0.15% In Sodium Chloride 0.9% In Plastic Container
NDA #017648 |
Potassium Chloride; Sodium Chloride | Injectable; Injection | SUPPL-71 | Baxter Hlthcare | Labeling | Approved |
| Potassium Chloride 0.224% In Sodium Chloride 0.9%
NDA #017648 |
Potassium Chloride; Sodium Chloride | Injectable; Injection | SUPPL-71 | Baxter Hlthcare | Labeling | Approved |
| Potassium Chloride 0.3% and Sodium Chloride 0.9% In Plastic Container
NDA #017648 |
Potassium Chloride; Sodium Chloride | Injectable; Injection | SUPPL-71 | Baxter Hlthcare | Labeling | Approved |
| Sodium Chloride 0.9% and Potassium Chloride 0.075% In Plastic Container
NDA #017648 |
Potassium Chloride; Sodium Chloride | Injectable; Injection | SUPPL-71 | Baxter Hlthcare | Labeling | Approved |
| Xyzal
NDA #022064 |
Levocetirizine Dihydrochloride | Tablet; Oral | SUPPL-37 | Sanofi Aventis Us | Labeling | Approved |
| Xyzal
NDA #022157 |
Levocetirizine Dihydrochloride | Solution; Oral | SUPPL-19 | Sanofi Aventis Us | Labeling | Approved |
January 10, 2019
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Fluoxetine Hydrochloride
ANDA #211282 |
Fluoxetine Hydrochloride | Tablet; Oral | ORIG-1 | Sciegen Pharms Inc | Approved | |
| Focalin
NDA #021278 |
Dexmethylphenidate Hydrochloride | Tablet; Oral | SUPPL-11 | Novartis | Labeling | Approved |
| Focalin
NDA #021278 |
Dexmethylphenidate Hydrochloride | Tablet; Oral | SUPPL-19 | Novartis | Labeling | Approved |
| Focalin Xr
NDA #021802 |
Dexmethylphenidate Hydrochloride | Capsule, Extended Release; Oral | SUPPL-19 | Novartis | Labeling | Approved |
| Focalin Xr
NDA #021802 |
Dexmethylphenidate Hydrochloride | Capsule, Extended Release; Oral | SUPPL-29 | Novartis | Labeling | Approved |
| Ingrezza
NDA #209241 |
Valbenazine Tosylate | Capsule; Oral | SUPPL-6 | Neurocrine | Manufacturing (CMC) | Approved |
| Olmesartan Medoxomil
ANDA #210552 |
Olmesartan Medoxomil | Tablet; Oral | ORIG-1 | Qilu Pharm Co Ltd | Approved | |
| Olopatadine Hydrochloride
ANDA #209015 |
Olopatadine Hydrochloride | Unknown | SUPPL-1 | Apotex Inc | Tentative Approval | |
| Ritalin
NDA #010187 |
Methylphenidate Hydrochloride | Tablet; Oral | SUPPL-71 | Novartis | Labeling | Approved |
| Ritalin
NDA #010187 |
Methylphenidate Hydrochloride | Tablet; Oral | SUPPL-82 | Novartis | Labeling | Approved |
| Ritalin La
NDA #021284 |
Methylphenidate Hydrochloride | Capsule, Extended Release; Oral | SUPPL-16 | Novartis | Labeling | Approved |
| Ritalin La
NDA #021284 |
Methylphenidate Hydrochloride | Capsule, Extended Release; Oral | SUPPL-29 | Novartis | Labeling | Approved |
| Ritalin-Sr
NDA #018029 |
Methylphenidate Hydrochloride | Tablet, Extended Release; Oral | SUPPL-41 | Novartis | Labeling | Approved |
| Ritalin-Sr
NDA #018029 |
Methylphenidate Hydrochloride | Tablet, Extended Release; Oral | SUPPL-51 | Novartis | Labeling | Approved |
January 9, 2019
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Cinqair
BLA #761033 |
Reslizumab | Injectable; Injection | SUPPL-10 | Teva Respiratory Llc | Labeling | Approved |
| Ingenol Mebutate
ANDA #209019 |
Ingenol Mebutate | Gel; Topical | ORIG-1 | Perrigo Uk Finco | Approved | |
| Levocetirizine Dihydrochloride
ANDA #090199 |
Levocetirizine Dihydrochloride | Tablet; Oral | SUPPL-12 | Teva Pharms | Labeling | Approved |
| Levocetirizine Dihydrochloride
ANDA #090199 |
Levocetirizine Dihydrochloride | Tablet; Oral | SUPPL-13 | Teva Pharms | Labeling | Approved |
| Mannitol 10%
NDA #016269 |
Mannitol | Injectable; Injection | SUPPL-55 | Hospira | Labeling | Approved |
| Mannitol 10% In Plastic Container
NDA #019603 |
Mannitol | Injectable; Injection | SUPPL-38 | Icu Medical Inc | Labeling | Approved |
| Mannitol 10% In Plastic Container
NDA #019603 |
Mannitol | Injectable; Injection | SUPPL-38 | Icu Medical Inc | Labeling | Approved |
| Mannitol 10% In Plastic Container
NDA #020006 |
Mannitol | Injectable; Injection | SUPPL-25 | B Braun | Labeling | Approved |
| Mannitol 15%
NDA #016269 |
Mannitol | Injectable; Injection | SUPPL-55 | Hospira | Labeling | Approved |
| Mannitol 15% In Plastic Container
NDA #019603 |
Mannitol | Injectable; Injection | SUPPL-38 | Icu Medical Inc | Labeling | Approved |
| Mannitol 15% In Plastic Container
NDA #019603 |
Mannitol | Injectable; Injection | SUPPL-38 | Icu Medical Inc | Labeling | Approved |
| Mannitol 15% In Plastic Container
NDA #020006 |
Mannitol | Injectable; Injection | SUPPL-25 | B Braun | Labeling | Approved |
| Mannitol 20%
NDA #016269 |
Mannitol | Injectable; Injection | SUPPL-55 | Hospira | Labeling | Approved |
| Mannitol 20% In Plastic Container
NDA #019603 |
Mannitol | Injectable; Injection | SUPPL-38 | Icu Medical Inc | Labeling | Approved |
| Mannitol 20% In Plastic Container
NDA #019603 |
Mannitol | Injectable; Injection | SUPPL-38 | Icu Medical Inc | Labeling | Approved |
| Mannitol 20% In Plastic Container
NDA #020006 |
Mannitol | Injectable; Injection | SUPPL-25 | B Braun | Labeling | Approved |
| Mannitol 25%
NDA #016269 |
Mannitol | Injectable; Injection | SUPPL-55 | Hospira | Labeling | Approved |
| Mannitol 5%
NDA #016269 |
Mannitol | Injectable; Injection | SUPPL-55 | Hospira | Labeling | Approved |
| Mannitol 5% In Plastic Container
NDA #019603 |
Mannitol | Injectable; Injection | SUPPL-38 | Icu Medical Inc | Labeling | Approved |
| Mannitol 5% In Plastic Container
NDA #019603 |
Mannitol | Injectable; Injection | SUPPL-38 | Icu Medical Inc | Labeling | Approved |
| Mannitol 5% In Plastic Container
NDA #020006 |
Mannitol | Injectable; Injection | SUPPL-25 | B Braun | Labeling | Approved |
| Methylprednisolone
ANDA #210985 |
Methylprednisolone | Tablet; Oral | ORIG-1 | Riconpharma Llc | Approved | |
| Natrecor
NDA #020920 |
Nesiritide Recombinant | For Solution; Intravenous | SUPPL-36 | Scios Llc | Labeling | Approved |
| Olopatadine Hydrochloride
ANDA #209015 |
Olopatadine Hydrochloride | Unknown | ORIG-1 | Apotex Inc | Tentative Approval | |
| Pregabalin
ANDA #209357 |
Pregabalin | Unknown | ORIG-1 | Msn Laboratories | Tentative Approval | |
| Proair Digihaler
NDA #205636 |
Albuterol Sulfate | Powder; Inhalation | SUPPL-12 | Teva Branded Pharm | Labeling | Approved |
| Proair Respiclick
NDA #205636 |
Albuterol Sulfate | Powder, Metered; Inhalation | SUPPL-12 | Teva Branded Pharm | Labeling | Approved |
| Vimpat
NDA #022253 |
Lacosamide | Tablet; Oral | SUPPL-41 | Ucb Inc | Efficacy | Approved |
| Vimpat
NDA #022254 |
Lacosamide | Solution; Intravenous | SUPPL-32 | Ucb Inc | Efficacy | Approved |
| Vimpat
NDA #022255 |
Lacosamide | Solution; Oral | SUPPL-23 | Ucb Inc | Efficacy | Approved |
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