| Product |
Company |
Generic name |
KEGG DRUG |
|
OMEGA-3-ACID ETHYL ESTERS capsule, liquid filled 1 g (ANDA)
|
REMEDYREPACK INC. |
OMEGA-3-ACID ETHYL ESTERS |
D05255
|
Humalog injection, solution 100 [iU]/mL (BLA)
Humalog KwikPen injection, solution 200 [iU]/mL (BLA)
Humalog Junior KwikPen injection, solution 100 [iU]/mL (BLA)
Humalog Tempo Pen injection, solution 100 [iU]/mL (BLA)
Humalog KwikPen injection, solution 100 [iU]/mL (BLA)
Sterile Diluent injection, solution 1 mL/mL (BLA)
|
Eli Lilly and Company |
diluent |
D04477
|
Deferoxamine mesylate injection, powder, lyophilized, for solution 500 mg (ANDA)
Deferoxamine mesylate injection, powder, lyophilized, for solution 2 g (ANDA)
|
Apotex Corp. |
Deferoxamine mesylate |
D01186
|
ADVAIR DISKUS powder 100 ug (NDA)
ADVAIR DISKUS powder 250 ug (NDA)
ADVAIR DISKUS powder 500 ug (NDA)
|
A-S Medication Solutions |
fluticasone propionate and salmeterol |
D08699
|
Metformin Hydrochloride tablet, extended release 500 mg (ANDA)
Metformin Hydrochloride tablet, extended release 750 mg (ANDA)
|
MARKSANS PHARMA LIMITED |
Metformin Hydrochloride |
D00944
|
|
Nalbuphine Hydrochloride injection 20 mg/mL (ANDA)
|
Henry Schein, Inc. |
nalbuphine hydrochloride |
D00843
|
|
Lamotrigine tablet, extended release 50 mg (ANDA)
|
REMEDYREPACK INC. |
Lamotrigine |
D00354
|
|
Nitrofurantoin (monohydrate/macrocrystals) capsule 25 mg (ANDA)
|
REMEDYREPACK INC. |
Nitrofurantoin (monohydrate/macrocrystals) |
D00439
|
|
sapropterin dihydrochloride tablet 100 mg (ANDA)
|
Par Health USA, LLC |
sapropterin dihydrochloride |
D01798
|
Metformin Hydrochloride tablet, extended release 500 mg (ANDA)
Metformin Hydrochloride tablet, extended release 1000 mg (ANDA)
|
Aurobindo Pharma Limited |
Metformin Hydrochloride |
D00944
|
|
febuxostat tablet 40 mg (ANDA)
|
REMEDYREPACK INC. |
febuxostat |
D01206
|
|
Chloroquine Phosphate tablet, coated 500 mg (ANDA)
|
Avet Pharmaceuticals Inc. |
Chloroquine Phosphate |
D02125
|
Sodium Chloride injection, solution 4.5 g000mL (NDA)
Sodium Chloride injection, solution 9 g000mL (NDA)
|
Baxter Healthcare Corporation |
Sodium Chloride |
D02056
|
Metformin Hydrochloride tablet, film coated 500 mg (ANDA)
Metformin Hydrochloride tablet, film coated 850 mg (ANDA)
Metformin Hydrochloride tablet, film coated 1000 mg (ANDA)
|
Aurobindo Pharma Limited |
Metformin Hydrochloride |
D00944
|
|
Carvedilol tablet, film coated 3.125 mg (ANDA)
|
A-S Medication Solutions |
Carvedilol |
D00255
|
Alprazolam tablet, orally disintegrating .25 mg (ANDA)
Alprazolam tablet, orally disintegrating .5 mg (ANDA)
Alprazolam tablet, orally disintegrating 1 mg (ANDA)
Alprazolam tablet, orally disintegrating 2 mg (ANDA)
|
Par Health USA, LLC |
alprazolam |
D00225
|
|
Pramipexole Dihydrochloride tablet 1.5 mg (ANDA)
|
A-S Medication Solutions |
Pramipexole Dihydrochloride |
D00559
|
Chlorthalidone tablet 25 mg (ANDA)
Chlorthalidone tablet 50 mg (ANDA)
|
Umedica Laboratories USA Inc. |
Chlorthalidone |
D00272
|
Tadalafil tablet, film coated 2.5 mg (ANDA)
Tadalafil tablet, film coated 5 mg (ANDA)
Tadalafil tablet, film coated 10 mg (ANDA)
Tadalafil tablet, film coated 20 mg (ANDA)
|
Umedica Laboratories USA Inc. |
Tadalafil |
D02008
|
Azilsartan Medoxomil tablet 40 mg (NDA)
Azilsartan Medoxomil tablet 80 mg (NDA)
|
Wilshire Pharmaceuticals, Inc. |
Azilsartan kamedoxomil |
D08865
|
RIZAFILM film 10 mg (NDA)
RIZAFILM film 5 mg (NDA)
|
Gensco Laboratories LLC |
rizatriptan benzoate |
D00675
|
prednisone tablet 1 mg (ANDA)
prednisone tablet 5 mg (ANDA)
|
Amneal Pharmaceuticals NY LLC |
prednisone |
D00473
|
Cefuroxime sodium injection, powder, for solution 750 mg (ANDA)
Cefuroxime sodium injection, powder, for solution 1.5 g/20mL (ANDA)
|
Sagent Pharmaceuticals |
Cefuroxime sodium |
D00915
|
|
Methylphenidate Hydrochloride tablet, extended release 72 mg (ANDA)
|
Sun Pharmaceutical Industries, Inc. |
Methylphenidate Hydrochloride |
D01296
|
Albuterol tablet 2 mg (ANDA)
Albuterol tablet 4 mg (ANDA)
|
Amneal Pharmaceuticals NY LLC |
Albuterol |
D00683
|
Clindamycin in 5 Percent Dextrose injection, solution 6 mg/mL (ANDA)
Clindamycin in 5 Percent Dextrose injection, solution 12 mg/mL (ANDA)
Clindamycin in 5 Percent Dextrose injection, solution 18 mg/mL (ANDA)
|
Sandoz Inc |
Clindamycin in 5 Percent Dextrose |
D01073
|
buprenorphine hydrochloride and naloxone hydrochloride dihydrate tablet 2 mg (ANDA)
buprenorphine hydrochloride and naloxone hydrochloride dihydrate tablet 8 mg (ANDA)
|
Golden State Medical Supply, Inc. |
buprenorphine hydrochloride and naloxone hydrochloride dihydrate |
D10250
|
|
Clindamycin Phosphate solution 10 mg/mL (ANDA)
|
Sun Pharmaceutical Industries, Inc. |
Clindamycin phosphate |
D01073
|
|
Pilocarpine Hydrochloride tablet, film coated 5 mg (ANDA)
|
Amneal Pharmaceuticals NY LLC |
PILOCARPINE HYDROCHLORIDE |
D02200
|
|
Ropivacaine Hydrochloride injection, solution 5 mg/mL (ANDA)
|
Sportpharm LLC |
Ropivacaine Hydrochloride |
D04048
|
Guanfacine Hydrochloride tablet 1 mg (ANDA)
Guanfacine Hydrochloride tablet 2 mg (ANDA)
|
Amneal Pharmaceuticals of New York LLC |
Guanfacine |
D00606
|
|
Ethacrynic Acid tablet 25 mg (ANDA)
|
Amneal Pharmaceuticals NY LLC |
Ethacrynic Acid |
D00313
|
Silodosin capsule 8 mg (ANDA)
Silodosin capsule 4 mg (ANDA)
|
Amneal Pharmaceuticals NY LLC |
Silodosin |
D01965
|
ZURZUVAE capsule 20 mg (NDA)
ZURZUVAE capsule 25 mg (NDA)
ZURZUVAE capsule 30 mg (NDA)
|
Biogen MA Inc. |
zuranolone |
D11793
|
Divalproex Sodium tablet, film coated, extended release 250 mg (ANDA)
Divalproex Sodium tablet, film coated, extended release 500 mg (ANDA)
|
Mylan Pharmaceuticals Inc. |
divalproex sodium |
D00304
|
|
Levothyroxine Sodium tablet .088 mg (ANDA)
|
Proficient Rx LP |
Levothyroxine Sodium |
D01010
|
|
DASH Chlorhexidine Gluconate 0.12% Oral Rinse liquid 1.2 mg/mL (ANDA)
|
Cardinal Health 107, LLC |
Chlorhexidine Gluconate 0.12% Oral Rinse |
D00858
|
|
PREDNISOLONE ACETATE suspension/ drops 10 mg/mL (NDA AUTHORIZED GENERIC)
|
Sportpharm LLC |
prednisolone acetate |
D00980
|
|
Magnesium Sulfate in Dextrose injection, solution 10 mg/mL (NDA)
|
Hospira, Inc. |
Magnesium Sulfate in Dextrose |
D01108
|
Pristiq Extended-Release tablet, extended release 50 mg (NDA)
Pristiq Extended-Release tablet, extended release 100 mg (NDA)
Pristiq Extended-Release tablet, extended release 25 mg (NDA)
|
Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. |
desvenlafaxine succinate |
D02570
|