| View |
|
DRHR-2218
|
Isopropyl Alcohol
|
Alco Lavender
|
70% (v/v)
|
Solution
|
-
|
Greenstone Pharmaceutical, Inc.
|
|
Initial (OTC)
|
23 March 2023
|
23 March 2028
|
| View |
|
DRHR-2219
|
Isopropyl Alcohol
|
Alco Lavender
|
70% (v/v)
|
Solution
|
-
|
Greenstone Pharmaceutical, Inc.
|
|
Initial (OTC)
|
23 March 2023
|
23 March 2028
|
| View |
|
DRHR-2222
|
Isopropyl Alcohol
|
Alco Lavender
|
70% (v/v)
|
Solution
|
-
|
Greenstone Pharmaceutical, Inc.
|
|
Initial (OTC)
|
23 March 2023
|
23 March 2028
|
| View |
|
DRHR-2224
|
Isopropyl Alcohol
|
Alco Ice
|
70% (v/v)
|
Solution
|
-
|
Greenstone Pharmaceutical, Inc.
|
|
Initial (OTC)
|
29 March 2023
|
29 March 2028
|
| View |
|
DRHR-2225
|
Isopropyl Alcohol
|
Alco Ice
|
70% (v/v)
|
Solution
|
-
|
Greenstone Pharmaceutical, Inc.
|
|
Initial (OTC)
|
29 March 2023
|
29 March 2028
|
| View |
|
DRHR-2226
|
Isopropyl Alcohol
|
Alco Ice
|
70% (v/v)
|
Solution
|
-
|
Greenstone Pharmaceutical, Inc.
|
|
Initial (OTC)
|
29 March 2023
|
29 March 2028
|
| View |
|
DRHR-2229
|
Isopropyl Alcohol
|
Alco Ice
|
70% (v/v)
|
Solution
|
-
|
Greenstone Pharmaceutical, Inc.
|
|
Initial (OTC)
|
30 March 2023
|
30 March 2028
|
| View |
|
DRHR-2231
|
Isopropyl Alcohol
|
Alco Ice
|
70% (v/v)
|
Solution
|
-
|
Greenstone Pharmaceutical, Inc.
|
|
Initial [OTC]
|
30 March 2023
|
30 March 2028
|
| View |
|
DRHR-2230
|
Isopropyl Alcohol
|
Alco Ice
|
70% (v/v)
|
Solution
|
-
|
Greenstone Pharmaceutical, Inc.
|
|
Initial [OTC]
|
30 March 2023
|
30 March 2028
|
| View |
|
DRHR-2223
|
Isopropyl Alcohol
|
Alco Lavender
|
70% (v/v)
|
Solution
|
-
|
Greenstone Pharmaceutical, Inc.
|
|
Initial [OTC]
|
23 March 2023
|
23 March 2028
|
| View |
|
DRP-13622
|
Digoxin
|
Cardoxin
|
250 mcg
|
Tablet
|
-
|
Globela Pharma Private Limited
|
|
Initial
|
21 March 2023
|
21 March 2028
|
| View |
|
DRP-13620
|
Losartan potassium + Amlodipine (as besilate)
|
Lossar XQ
|
50 mg/5 mg
|
Film Coated Tablet
|
-
|
Globela Pharma Private Limited
|
|
Initial
|
21 March 2023
|
21 March 2028
|
| View |
|
DRP-13621
|
Losartan potassium + Amlodipine (as besilate)
|
Lossar XQ
|
100 mg/5 mg
|
Film Coated Tablet
|
-
|
Globela Pharma Private Limited
|
|
Initial
|
21 March 2023
|
21 March 2028
|
| View |
|
DRP-13673
|
Ampicillin (As Sodium)
|
Corpilyn
|
500 mg
|
Powder for Injection (IM/IV)
|
-
|
Uni Medicolabs, Inc.
|
|
Initial
|
24 March 2023
|
24 March 2028
|
| View |
|
DRP-13674
|
Ampicillin (As Sodium)
|
Corpilyn
|
250 mg
|
Powder for Injection (IM/IV)
|
-
|
Uni Medicolabs, Inc.
|
|
Initial
|
24 March 2023
|
24 March 2028
|
| View |
DR-XY48662_PI_01.pdf
|
DR-XY48662
|
Teriflunomide
|
None
|
14mg
|
Tablet
|
-
|
Shilpa Medicare Limited (Unit-4, Pharmaceutical Formulations Sez)
|
|
Monitored Release (Reapplication)
|
22 March 2023
|
22 March 2028
|
| View |
|
DRP-13649
|
Cefuroxime (as axetil)
|
None
|
500 mg
|
Film-Coated Tablet
|
-
|
Pharmavision San. Ve Tic. A.S.
|
|
Initial
|
23 March 2023
|
23 March 2028
|
| View |
|
DRP-13662
|
Enalapril maleate
|
Enaprimed-5
|
5 mg
|
Film-Coated Tablet
|
-
|
Saga Lifesciences Limited
|
India
|
Initial
|
23 March 2023
|
23 March 2028
|
| View |
|
DR-XY48659
|
Indacaterol (as acetate) + Glycopyrronium (as bromide)
+ Mometasone Furoate
|
None
|
150 mcg/ 50 mcg/ 160 mcg
|
Powder for Inhalation in Hard Capsule
|
-
|
Novartis Pharma Stein AG
|
|
Monitored Release
|
21 March 2023
|
21 March 2028
|
| View |
|
DRP-13685
|
Ceftriaxone (as sodium)
|
Medtaxone
|
1 g
|
Powder for Injection (I.M./I.V.)
|
-
|
Reyoung Pharmaceutical Co. Ltd.
|
|
Initial
|
28 March 2023
|
28 March 2028
|