Viatris Unclassified
FDA Approved Drugs
Viatris Unclassified
FDA Approved Drugs Database
FDA approved drug product records including application numbers, product numbers, drug names, active ingredients, dosage forms, strengths, approval dates and regulatory status.
- Total Records 87
- Latest Approval Date -
- Data Source FDA
- First Approval Date -
Company Overview
Social Profiles
Company Snapshot
Viatris Unclassified
Robert J. Coury Global Center 1000 Mylan Blvd. Canonsburg, PA 15317
U.S.A
www.viatris.com/en HRServiceCenter@Viatris.com View on MapFDA Approved Drug Records ( 87 records )
Drug Name
ABACAVIR SULFATE
Product Number
1
Dosage Form
-
Strength
60 MG
Approval Date
-
Active Ingredient
ABACAVIR SULFATE
Application Number
200733
Product Number
1
Dosage Form
-
Strength
60 MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
ABACAVIR SULFATE; LAMIVUDINE
Product Number
1
Dosage Form
-
Strength
600MG; 300MG
Approval Date
-
Active Ingredient
ABACAVIR SULFATE; LAMIVUDINE
Application Number
90519
Product Number
1
Dosage Form
-
Strength
600MG; 300MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
ABACAVIR SULFATE; LAMIVUDINE
Product Number
1
Dosage Form
-
Strength
60MG; 30MG
Approval Date
-
Active Ingredient
ABACAVIR SULFATE; LAMIVUDINE
Application Number
202381
Product Number
1
Dosage Form
-
Strength
60MG; 30MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
AMITRIPTYLINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
-
Active Ingredient
AMITRIPTYLINE HYDROCHLORIDE
Application Number
86010
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
AMITRIPTYLINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
75MG
Approval Date
-
Active Ingredient
AMITRIPTYLINE HYDROCHLORIDE
Application Number
86011
Product Number
1
Dosage Form
-
Strength
75MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
AMITRIPTYLINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
150MG
Approval Date
-
Active Ingredient
AMITRIPTYLINE HYDROCHLORIDE
Application Number
86153
Product Number
1
Dosage Form
-
Strength
150MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
AMITRIPTYLINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
-
Active Ingredient
AMITRIPTYLINE HYDROCHLORIDE
Application Number
86157
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
AMITRIPTYLINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
-
Active Ingredient
AMITRIPTYLINE HYDROCHLORIDE
Application Number
86158
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
AMLODIPINE AND OLMESARTAN MEDOXOMIL
Product Number
1
Dosage Form
-
Strength
5MG/20MG
Approval Date
-
Active Ingredient
AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL
Application Number
90398
Product Number
1
Dosage Form
-
Strength
5MG/20MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
AMLODIPINE AND OLMESARTAN MEDOXOMIL
Product Number
2
Dosage Form
-
Strength
5MG/40MG
Approval Date
-
Active Ingredient
AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL
Application Number
90398
Product Number
2
Dosage Form
-
Strength
5MG/40MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
AMLODIPINE AND OLMESARTAN MEDOXOMIL
Product Number
3
Dosage Form
-
Strength
10MG/20MG
Approval Date
-
Active Ingredient
AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL
Application Number
90398
Product Number
3
Dosage Form
-
Strength
10MG/20MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
AMLODIPINE AND OLMESARTAN MEDOXOMIL
Product Number
4
Dosage Form
-
Strength
10MG/40MG
Approval Date
-
Active Ingredient
AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL
Application Number
90398
Product Number
4
Dosage Form
-
Strength
10MG/40MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
ATAZANAVIR SULFATE
Product Number
1
Dosage Form
-
Strength
150MG
Approval Date
-
Active Ingredient
ATAZANAVIR SULFATE
Application Number
91611
Product Number
1
Dosage Form
-
Strength
150MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
ATAZANAVIR SULFATE AND RITONAVIR
Product Number
1
Dosage Form
-
Strength
300MG/100MG
Approval Date
-
Active Ingredient
ATAZANAVIR SULFATE; RITONAVIR
Application Number
22282
Product Number
1
Dosage Form
-
Strength
300MG/100MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
BALSALAZIDE DISODIUM
Product Number
1
Dosage Form
-
Strength
1.1G
Approval Date
-
Active Ingredient
BALSALAZIDE DISODIUM
Application Number
206909
Product Number
1
Dosage Form
-
Strength
1.1G
Approval Date
-
Regulatory Status
Unclassified
Drug Name
CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 12.5MG BASE;5MG
Approval Date
-
Active Ingredient
AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE
Application Number
71296
Product Number
1
Dosage Form
-
Strength
EQ 12.5MG BASE;5MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
CLOZAPINE
Product Number
1
Dosage Form
-
Strength
12.5MG
Approval Date
-
Active Ingredient
CLOZAPINE
Application Number
201824
Product Number
1
Dosage Form
-
Strength
12.5MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
DARUNAVIR AND RITONAVIR
Product Number
1
Dosage Form
-
Strength
400MG/50MG
Approval Date
-
Active Ingredient
DARUNAVIR AND RITONAVIR
Application Number
209847
Product Number
1
Dosage Form
-
Strength
400MG/50MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
DOLUTEGRAVIR, LAMIVUDINE, AND TENOFOVIR DISOPROXIL FUMARATE
Product Number
1
Dosage Form
-
Strength
50MG;300MG;300MG
Approval Date
-
Active Ingredient
DOLUTEGRAVIR;LAMIVUDINE;TENOFOVIR DISOPROXIL FUMARATE
Application Number
209670
Product Number
1
Dosage Form
-
Strength
50MG;300MG;300MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
DOXEPIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 25MG BASE
Approval Date
-
Active Ingredient
DOXEPIN HYDROCHLORIDE
Application Number
70790
Product Number
1
Dosage Form
-
Strength
EQ 25MG BASE
Approval Date
-
Regulatory Status
Unclassified
Drug Name
DOXEPIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 75MG BASE
Approval Date
-
Active Ingredient
DOXEPIN HYDROCHLORIDE
Application Number
70792
Product Number
1
Dosage Form
-
Strength
EQ 75MG BASE
Approval Date
-
Regulatory Status
Unclassified
Drug Name
DOXEPIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
-
Active Ingredient
DOXEPIN HYDROCHLORIDE
Application Number
70793
Product Number
1
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
-
Regulatory Status
Unclassified
Drug Name
DOXYCYCLINE
Product Number
1
Dosage Form
-
Strength
40MG
Approval Date
-
Active Ingredient
DOXYCYCLINE
Application Number
90855
Product Number
1
Dosage Form
-
Strength
40MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
EFAVIRENZ
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
-
Active Ingredient
EFAVIRENZ
Application Number
22461
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
EFAVIRENZ
Product Number
2
Dosage Form
-
Strength
100MG
Approval Date
-
Active Ingredient
EFAVIRENZ
Application Number
22461
Product Number
2
Dosage Form
-
Strength
100MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
EFAVIRENZ
Product Number
3
Dosage Form
-
Strength
200MG
Approval Date
-
Active Ingredient
EFAVIRENZ
Application Number
22461
Product Number
3
Dosage Form
-
Strength
200MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
EFAVIRENZ, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE
Product Number
1
Dosage Form
-
Strength
400MG; 200MG; 25MG
Approval Date
-
Active Ingredient
EFAVIRENZ, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE
Application Number
213509
Product Number
1
Dosage Form
-
Strength
400MG; 200MG; 25MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
Product Number
1
Dosage Form
-
Strength
600MG; 200MG; 300MG
Approval Date
-
Active Ingredient
EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
Application Number
90437
Product Number
1
Dosage Form
-
Strength
600MG; 200MG; 300MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
EMTRICITABINE
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
-
Active Ingredient
EMTRICITABINE
Application Number
90488
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
Product Number
1
Dosage Form
-
Strength
200MG; 300MG
Approval Date
-
Active Ingredient
EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
Application Number
90049
Product Number
1
Dosage Form
-
Strength
200MG; 300MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
EPZICOM
Product Number
1
Dosage Form
-
Strength
600MG;300MG
Approval Date
-
Active Ingredient
ABACAVIR;LAMIVUDINE
Application Number
204004
Product Number
1
Dosage Form
-
Strength
600MG;300MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
ESTRADIOL
Product Number
1
Dosage Form
-
Strength
0.025MG/DAY
Approval Date
-
Active Ingredient
ESTRADIOL
Application Number
20167
Product Number
1
Dosage Form
-
Strength
0.025MG/DAY
Approval Date
-
Regulatory Status
Unclassified
Drug Name
ESTRADIOL
Product Number
2
Dosage Form
-
Strength
0.0375MG/DAY
Approval Date
-
Active Ingredient
ESTRADIOL
Application Number
20167
Product Number
2
Dosage Form
-
Strength
0.0375MG/DAY
Approval Date
-
Regulatory Status
Unclassified
Drug Name
ESTRADIOL
Product Number
3
Dosage Form
-
Strength
0.05MG/DAY
Approval Date
-
Active Ingredient
ESTRADIOL
Application Number
20167
Product Number
3
Dosage Form
-
Strength
0.05MG/DAY
Approval Date
-
Regulatory Status
Unclassified
Drug Name
ESTRADIOL
Product Number
4
Dosage Form
-
Strength
0.075MG/DAY
Approval Date
-
Active Ingredient
ESTRADIOL
Application Number
20167
Product Number
4
Dosage Form
-
Strength
0.075MG/DAY
Approval Date
-
Regulatory Status
Unclassified
Drug Name
ESTRADIOL
Product Number
5
Dosage Form
-
Strength
0.1MG/DAY
Approval Date
-
Active Ingredient
ESTRADIOL
Application Number
20167
Product Number
5
Dosage Form
-
Strength
0.1MG/DAY
Approval Date
-
Regulatory Status
Unclassified
Drug Name
ESTRADIOL
Product Number
1
Dosage Form
-
Strength
0.05MG/24HR
Approval Date
-
Active Ingredient
ESTRADIOL
Application Number
75233
Product Number
1
Dosage Form
-
Strength
0.05MG/24HR
Approval Date
-
Regulatory Status
Unclassified
Drug Name
FENTANYL
Product Number
1
Dosage Form
-
Strength
100MCG
Approval Date
-
Active Ingredient
FENTANYL
Application Number
202577
Product Number
1
Dosage Form
-
Strength
100MCG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
FENTANYL
Product Number
2
Dosage Form
-
Strength
200MCG
Approval Date
-
Active Ingredient
FENTANYL
Application Number
202577
Product Number
2
Dosage Form
-
Strength
200MCG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
FENTANYL
Product Number
3
Dosage Form
-
Strength
300MCG
Approval Date
-
Active Ingredient
FENTANYL
Application Number
202577
Product Number
3
Dosage Form
-
Strength
300MCG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
FENTANYL
Product Number
4
Dosage Form
-
Strength
400MCG
Approval Date
-
Active Ingredient
FENTANYL
Application Number
202577
Product Number
4
Dosage Form
-
Strength
400MCG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
FENTANYL
Product Number
5
Dosage Form
-
Strength
600MCG
Approval Date
-
Active Ingredient
FENTANYL
Application Number
202577
Product Number
5
Dosage Form
-
Strength
600MCG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
FENTANYL
Product Number
6
Dosage Form
-
Strength
800MCG
Approval Date
-
Active Ingredient
FENTANYL
Application Number
202577
Product Number
6
Dosage Form
-
Strength
800MCG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
FEXOFENADINE HCL; PSEUDOEPHEDRINE HCL
Product Number
1
Dosage Form
-
Strength
60/120MG
Approval Date
-
Active Ingredient
FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
Application Number
76538
Product Number
1
Dosage Form
-
Strength
60/120MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
HULIO
Product Number
1
Dosage Form
-
Strength
20MG;0.4ML
Approval Date
-
Active Ingredient
ADALIMUMAB-FKJP
Application Number
761154
Product Number
1
Dosage Form
-
Strength
20MG;0.4ML
Approval Date
-
Regulatory Status
Unclassified
Drug Name
LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE; NEVIRAPINE
Product Number
1
Dosage Form
-
Strength
300MG; 300MG; 200MG
Approval Date
-
Active Ingredient
LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE; NEVIRAPINE
Application Number
202171
Product Number
1
Dosage Form
-
Strength
300MG; 300MG; 200MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
LAMIVUDINE; ZIDOVUDINE
Product Number
1
Dosage Form
-
Strength
30MG; 60MG
Approval Date
-
Active Ingredient
LAMIVUDINE; ZIDOVUDINE
Application Number
200748
Product Number
1
Dosage Form
-
Strength
30MG; 60MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
LAMIVUDINE; ZIDOVUDINE
Product Number
1
Dosage Form
-
Strength
30MG; 60MG
Approval Date
-
Active Ingredient
LAMIVUDINE; ZIDOVUDINE
Application Number
204914
Product Number
1
Dosage Form
-
Strength
30MG; 60MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
LEVOTHYROXINE SODIUM
Product Number
1
Dosage Form
-
Strength
0.025MG
Approval Date
-
Active Ingredient
LEVOTHYROXINE SODIUM
Application Number
76764
Product Number
1
Dosage Form
-
Strength
0.025MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
LEVOTHYROXINE SODIUM
Product Number
2
Dosage Form
-
Strength
0.050MG
Approval Date
-
Active Ingredient
LEVOTHYROXINE SODIUM
Application Number
76764
Product Number
2
Dosage Form
-
Strength
0.050MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
LEVOTHYROXINE SODIUM
Product Number
3
Dosage Form
-
Strength
0.075MG
Approval Date
-
Active Ingredient
LEVOTHYROXINE SODIUM
Application Number
76764
Product Number
3
Dosage Form
-
Strength
0.075MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
LEVOTHYROXINE SODIUM
Product Number
4
Dosage Form
-
Strength
0.088MG
Approval Date
-
Active Ingredient
LEVOTHYROXINE SODIUM
Application Number
76764
Product Number
4
Dosage Form
-
Strength
0.088MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
LEVOTHYROXINE SODIUM
Product Number
5
Dosage Form
-
Strength
0.1MG
Approval Date
-
Active Ingredient
LEVOTHYROXINE SODIUM
Application Number
76764
Product Number
5
Dosage Form
-
Strength
0.1MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
LEVOTHYROXINE SODIUM
Product Number
6
Dosage Form
-
Strength
0.112MG
Approval Date
-
Active Ingredient
LEVOTHYROXINE SODIUM
Application Number
76764
Product Number
6
Dosage Form
-
Strength
0.112MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
LEVOTHYROXINE SODIUM
Product Number
7
Dosage Form
-
Strength
0.125MG
Approval Date
-
Active Ingredient
LEVOTHYROXINE SODIUM
Application Number
76764
Product Number
7
Dosage Form
-
Strength
0.125MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
LEVOTHYROXINE SODIUM
Product Number
8
Dosage Form
-
Strength
0.15MG
Approval Date
-
Active Ingredient
LEVOTHYROXINE SODIUM
Application Number
76764
Product Number
8
Dosage Form
-
Strength
0.15MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
LEVOTHYROXINE SODIUM
Product Number
9
Dosage Form
-
Strength
0.175MG
Approval Date
-
Active Ingredient
LEVOTHYROXINE SODIUM
Application Number
76764
Product Number
9
Dosage Form
-
Strength
0.175MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
LEVOTHYROXINE SODIUM
Product Number
10
Dosage Form
-
Strength
0.2MG
Approval Date
-
Active Ingredient
LEVOTHYROXINE SODIUM
Application Number
76764
Product Number
10
Dosage Form
-
Strength
0.2MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
LEVOTHYROXINE SODIUM
Product Number
11
Dosage Form
-
Strength
0.3MG
Approval Date
-
Active Ingredient
LEVOTHYROXINE SODIUM
Application Number
76764
Product Number
11
Dosage Form
-
Strength
0.3MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
LINAGLIPTIN; METFORMIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
2.5MG;500MG
Approval Date
-
Active Ingredient
LINAGLIPTIN;METFORMIN HYDROCHLORIDE
Application Number
208430
Product Number
1
Dosage Form
-
Strength
2.5MG;500MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
LINAGLIPTIN; METFORMIN HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
2.5MG;850MG
Approval Date
-
Active Ingredient
LINAGLIPTIN;METFORMIN HYDROCHLORIDE
Application Number
208430
Product Number
2
Dosage Form
-
Strength
2.5MG;850MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
LINAGLIPTIN; METFORMIN HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
2.5MG;1GM
Approval Date
-
Active Ingredient
LINAGLIPTIN;METFORMIN HYDROCHLORIDE
Application Number
208430
Product Number
3
Dosage Form
-
Strength
2.5MG;1GM
Approval Date
-
Regulatory Status
Unclassified
Drug Name
METHYLDOPA
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
-
Active Ingredient
METHYLDOPA
Application Number
70075
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
MILNACIPRAN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
12.5MG
Approval Date
-
Active Ingredient
MILNACIPRAN HYDROCHLORIDE
Application Number
205367
Product Number
1
Dosage Form
-
Strength
12.5MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
MILNACIPRAN HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
25MG
Approval Date
-
Active Ingredient
MILNACIPRAN HYDROCHLORIDE
Application Number
205367
Product Number
2
Dosage Form
-
Strength
25MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
MILNACIPRAN HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
50MG
Approval Date
-
Active Ingredient
MILNACIPRAN HYDROCHLORIDE
Application Number
205367
Product Number
3
Dosage Form
-
Strength
50MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
MILNACIPRAN HYDROCHLORIDE
Product Number
4
Dosage Form
-
Strength
100MG
Approval Date
-
Active Ingredient
MILNACIPRAN HYDROCHLORIDE
Application Number
205367
Product Number
4
Dosage Form
-
Strength
100MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
NITROGLYCERIN
Product Number
1
Dosage Form
-
Strength
0.2MG/HR
Approval Date
-
Active Ingredient
NITROGLYCERIN
Application Number
75073
Product Number
1
Dosage Form
-
Strength
0.2MG/HR
Approval Date
-
Regulatory Status
Unclassified
Drug Name
NITROGLYCERIN
Product Number
1
Dosage Form
-
Strength
0.4MG/HR
Approval Date
-
Active Ingredient
NITROGLYCERIN
Application Number
75075
Product Number
1
Dosage Form
-
Strength
0.4MG/HR
Approval Date
-
Regulatory Status
Unclassified
Drug Name
NITROGLYCERIN
Product Number
1
Dosage Form
-
Strength
0.1MG/HR
Approval Date
-
Active Ingredient
NITROGLYCERIN
Application Number
75076
Product Number
1
Dosage Form
-
Strength
0.1MG/HR
Approval Date
-
Regulatory Status
Unclassified
Drug Name
Oxybutynin Chloride
Product Number
1
Dosage Form
-
Strength
15 MG.
Approval Date
-
Active Ingredient
Oxybutynin Chloride
Application Number
78293
Product Number
1
Dosage Form
-
Strength
15 MG.
Approval Date
-
Regulatory Status
Unclassified
Drug Name
PALIPERIDONE PALMITATE
Product Number
1
Dosage Form
-
Strength
273MG/0.88ML
Approval Date
-
Active Ingredient
PALIPERIDONE PALMITATE
Application Number
216228
Product Number
1
Dosage Form
-
Strength
273MG/0.88ML
Approval Date
-
Regulatory Status
Unclassified
Drug Name
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
10MG;2MG
Approval Date
-
Active Ingredient
AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE
Application Number
70336
Product Number
1
Dosage Form
-
Strength
10MG;2MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
25MG;2MG
Approval Date
-
Active Ingredient
AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE
Application Number
70337
Product Number
1
Dosage Form
-
Strength
25MG;2MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
25MG;4MG
Approval Date
-
Active Ingredient
AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE
Application Number
70338
Product Number
1
Dosage Form
-
Strength
25MG;4MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
10MG;4MG
Approval Date
-
Active Ingredient
AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE
Application Number
71442
Product Number
1
Dosage Form
-
Strength
10MG;4MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
PRAZOSIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 1MG BASE
Approval Date
-
Active Ingredient
PRAZOSIN HYDROCHLORIDE
Application Number
72573
Product Number
1
Dosage Form
-
Strength
EQ 1MG BASE
Approval Date
-
Regulatory Status
Unclassified
Drug Name
PRAZOSIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 2MG BASE
Approval Date
-
Active Ingredient
PRAZOSIN HYDROCHLORIDE
Application Number
72574
Product Number
1
Dosage Form
-
Strength
EQ 2MG BASE
Approval Date
-
Regulatory Status
Unclassified
Drug Name
RITONAVIR
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
-
Active Ingredient
RITONAVIR
Application Number
202738
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
RIVAROXABAN
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
-
Active Ingredient
RIVAROXABAN
Application Number
212220
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
SEMGLEE
Product Number
1
Dosage Form
-
Strength
100 UNITS/ML
Approval Date
-
Active Ingredient
INSULIN GLARGINE
Application Number
210605
Product Number
1
Dosage Form
-
Strength
100 UNITS/ML
Approval Date
-
Regulatory Status
Unclassified
Drug Name
SEMGLEE
Product Number
1
Dosage Form
-
Strength
10ML(100UNITS/ML)
Approval Date
-
Active Ingredient
INSULIN GLARGINE-YFGN
Application Number
761201
Product Number
1
Dosage Form
-
Strength
10ML(100UNITS/ML)
Approval Date
-
Regulatory Status
Unclassified
Drug Name
SEMGLEE
Product Number
2
Dosage Form
-
Strength
3ML(100UNITS/ML)
Approval Date
-
Active Ingredient
INSULIN GLARGINE-YFGN
Application Number
761201
Product Number
2
Dosage Form
-
Strength
3ML(100UNITS/ML)
Approval Date
-
Regulatory Status
Unclassified
Drug Name
SITAGLIPTIN PHOSPHATE
Product Number
1
Dosage Form
-
Strength
EQ 25MG BASE
Approval Date
-
Active Ingredient
SITAGLIPTIN PHOSPHATE
Application Number
202473
Product Number
1
Dosage Form
-
Strength
EQ 25MG BASE
Approval Date
-
Regulatory Status
Unclassified
Drug Name
SITAGLIPTIN PHOSPHATE
Product Number
2
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
-
Active Ingredient
SITAGLIPTIN PHOSPHATE
Application Number
202473
Product Number
2
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
-
Regulatory Status
Unclassified
Drug Name
SITAGLIPTIN PHOSPHATE
Product Number
3
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
-
Active Ingredient
SITAGLIPTIN PHOSPHATE
Application Number
202473
Product Number
3
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
-
Regulatory Status
Unclassified
Drug Name
SULINDAC
Product Number
1
Dosage Form
-
Strength
150MG
Approval Date
-
Active Ingredient
SULINDAC
Application Number
73038
Product Number
1
Dosage Form
-
Strength
150MG
Approval Date
-
Regulatory Status
Unclassified
Drug Status Breakdown
87 total- Unclassified
Official Source
FDA approved drug data is based on publicly available U.S. Food and Drug Administration Orange Book information.
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Drug Name
ABACAVIR SULFATE
Application Number
200733
Product Number
1
Active Ingredient
ABACAVIR SULFATE
Dosage Form
-
Strength
60 MG
FDA Approved Drug Data
Approved drug product information
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