| View |
|
DRP-916
|
Multivitamins (see reverse for formulation)
|
Mountbion
|
Solution for Injection (IM/IV)
|
Solution for Injection (IM/IV)
|
Prescription Drug (Rx)
|
Ampoule x 3 mL in Alu Blister Pack x 5's Box of 10's
|
Vitamins
|
Mount Mettur Pharmaceuticals Ltd.
|
India
|
N/A
|
Pharma-Surrey International, Inc
|
Pharma-Surrey International, Inc
|
Renewal
|
10 August 2022
|
18 September 2027
|
| View |
|
DRP-9162
|
Celecoxib
|
None
|
200mg
|
Capsule
|
Prescription Drug (Rx)
|
Alu-Alu Blister pack x 10's (box of 30's)
|
Selective COX-2 Inhibitor
|
Zim Laboratories Limited
|
India
|
|
I.E. Medica, Inc.
|
MedEthix, Inc.
|
Automatic Renewal
|
19 July 2023
|
21 September 2028
|
| View |
|
DRP-9163
|
Celecoxib
|
None
|
200mg
|
Capsule
|
Prescription Drug (Rx)
|
Alu-Alu Blister pack x 10's (box of 30's)
|
Selective COX-2 Inhibitor
|
Zim Laboratories Limited
|
India
|
|
I. E. Medica, Inc.
|
|
Automatic Renewal
|
27 July 2023
|
21 September 2028
|
| View |
|
DRP-9163-01
|
Celecoxib
|
Recosan
|
200mg
|
Capsule
|
Prescription Drug (Rx)
|
Alu/Alu Blister Pack x 10's (Box of 30's)
|
Selective COX-2 Inhibitor
|
Zim Laboratories Limited
|
India
|
N/A
|
I.E. Medica, Inc.
|
Philmeds Trading
|
Renewal
|
08 July 2022
|
21 September 2028
|
| View |
|
DRP-9166
|
Clopidogrel (as bisulfate)
|
Clopinova
|
75 mg
|
Film-Coated Tablet
|
Prescription Drug (RX)
|
ALU-ALU BLISTER PACK BY 10'S (Box of 100's)
|
-
|
Zim Laboratories Limited
|
India
|
|
Medinova Pharmaceutical, Inc.
|
Medinova Pharmaceutical, Inc.
|
Initial
|
21 September 2020
|
21 September 2025
|
| View |
|
DRP-9166-01
|
Clopidogrel (as bisulfate)
|
Clopegen
|
75mg
|
Film-Coated Tablet
|
Prescription Drug (RX)
|
Alu/Alu Blister Pack x 10's (Box of 100's)
|
-
|
Zim Laboratories Limited
|
India
|
|
Medinova Pharmaceutical Inc.
|
GA2 Pharmaceutical Inc
|
-
|
06 October 2021
|
21 September 2025
|
| View |
|
DRP-9166-02
|
Clopidogrel (as bisulfate)
|
Cassagrel
|
75mg
|
Film-Coated Tablet
|
Prescription Drug (RX)
|
Alu/Alu Blister pack x 10's (Box of 100's)
|
-
|
Zim Laboratories Limited
|
India
|
|
MEDINOVA PHARMACEUTICAL INC.,
|
Cassandras Care Pharmaceutical Dsitributions
|
-
|
13 October 2021
|
21 September 2025
|
| View |
|
DRP-9166-03
|
Clopidogrel (As Bisulfate)
|
Clopitreve
|
75mg
|
Film-Coated Tablet
|
Prescription Drug (RX)
|
Alu/Alu Blister Pack x 10's (Box of 100's)
|
Antithrombotic Agent (Platelet Aggregation Inhibitor)
|
Zim Laboratories Limited
|
India
|
N/A
|
Medinova Pharmaceutical, Inc.
|
Tri-eve Pharmaceutical Marketing
|
CLIDP
|
28 January 2022
|
21 September 2025
|
| View |
|
DRP-9166-04
|
Clopidogrel (as bisulfate)
|
Giclopid
|
75mg
|
Film-Coated Tablet
|
Prescription Drug (RX)
|
Alu/Alu Blister Pack x 10's (Box of 100's)
|
Antithrombotic Agent (Platelet Aggregation Inhibitor)
|
Zim Laboratories Limited
|
India
|
N/A
|
Medinova Pharmaceutical Inc.
|
Gijun Trading Inc.
|
CLIDP
|
02 March 2022
|
21 September 2025
|
| View |
|
DRP-9166-05
|
Clopidogrel
|
Clopitor
|
75 mg
|
Film-Coated Tablet
|
Prescription Drug (Rx)
|
Alu/Alu Blister Pack of 10's (Box of 100's)
|
Antithrombotic Agent (Platelet Aggregation Inhibitor)
|
Zim Laboratories Limited
|
India
|
N/A
|
Medinova Pharmaceutical Inc.
|
Altor Pharmaceutical Product Distribution
|
CLIDP Conversion
|
18 October 2023
|
21 December 2025
|
| View |
|
DRP-9166-06
|
Clopidogrel
|
Clopicard
|
75mg
|
Film-Coated Tablet
|
Prescription Drug (Rx)
|
Alu/Alu Blister Pack x 10's (Box of 100's)
|
Antithrombotic Agent
|
Zim Laboratories Limited
|
India
|
N/A
|
Medinova Pharmaceutical Inc
|
Life And Health Source Pharmaceutical Distribution Co.
|
CLIDP Conversion
|
13 September 2023
|
21 September 2025
|
| View |
|
DRP-9166-07
|
Clopidogrel
|
Goplat
|
75 mg
|
Film-Coated Tablet
|
Prescription Drug (Rx)
|
Alu/Alu Blister Pack x 10's / (Box of 100's)
|
Antithrombotic Agent
|
Zim Laboratories Limited
|
India
|
|
Medinova Pharmaceutical Inc.
|
Applied Pharmaceutical Distribution Inc
|
CLIDP Conversion
|
05 February 2024
|
21 September 2025
|
| View |
|
DRP-9166-08
|
Clopidogrel (as bisulfate)
|
Cardiplat
|
75 mg
|
Film-Coated Tablet
|
Prescription Drug (Rx)
|
Alu/Alu Blister Pack x 10’s / (Box of 30’s; Box of 100’s)
|
Antithrombotic Agent (Platelet Aggregation Inhibitor)
|
Zim Laboratories Limited
|
India
|
|
Medinova Pharmaceutical Inc.
|
GA2 Pharmaceutical Inc
|
CLIDP Conversion
|
03 March 2024
|
21 September 2025
|
| View |
|
DRP-9167-01
|
Acetylcysteine
|
Mucucil
|
600 mg
|
Granules For Solution (Orange Flavor)
|
Prescription Drug (RX)
|
PE/Alu/Paper Thermo-Sealed Sachet (Box of 30's)
|
Mucolytic
|
Drugmaker's Laboratories, Inc.
|
Philippines
|
|
|
Terramedic, Inc.
|
Automatic Renewal
|
12 April 2022
|
21 September 2027
|
| View |
|
DRP-9168-01
|
This CPR is granted following A.O. 31 s. 2005.
|
Mucucil
|
100 mg
|
Granules for Solution (Orange Flavor)
|
Prescription Drug (RX)
|
PE/Alu/Paper Thermo-Sealed Sachet (Box of 30's)
|
Mucolytic
|
Drugmaker's Laboratories, Inc.
|
Philippines
|
|
|
Terramedic, Inc.
|
Automatic Renewal
|
12 April 2022
|
21 September 2027
|
| View |
|
DRP-9169-01
|
Acetylcysteine
|
Mucucil
|
200 mg
|
Granules For Solution (Orange Flavor)
|
Prescription Drug (RX)
|
PE/Alu/Paper Thermo-Sealed Sachet (Box of 30's)
|
Mucolytic
|
Drugmaker's Laboratories, Inc.
|
Philippines
|
|
|
Terramedic, Inc.
|
Automatic Renewal
|
11 November 2022
|
21 September 2027
|
| View |
|
DRP-9170
|
Budesonide
|
Buderite
|
250mcg/mL (500mcg/2mL)
|
Suspension for Nebulization
|
Prescription Drug (Rx)
|
2ml LDPE ampoule x 5's in aluminum pouch (box of 25's)
|
Glucocorticoid
|
Legency Rmedies Pvt. Ltd.
|
India
|
|
Suhitas Pharmaceuticals Inc.
|
Preventia Healthcare Inc.
|
Initial
|
22 September 2020
|
22 September 2025
|
| View |
|
DRP-9170-01
|
Budesonide
|
Zyics
|
250 mcg/mL (500 mcg/2 mL)
|
Suspension for Nebulization
|
Prescription Drug (Rx)
|
2 mL LDPE ampoule x 5's in aluminum pouch (Box of 25's)
|
Glucocorticoid
|
Legency Remedies Pvt. Ltd.
|
India
|
N/A
|
Suhitas Pharmaceuticals Inc.
|
Zydus Healthcare Philippines Inc.
|
-
|
22 October 2022
|
22 September 2025
|
| View |
|
DRP-9170-02
|
Budesonide
|
MD-SONIDE
|
250 mcg/mL (500 mcg/ 2 mL)
|
Suspension for Nebulization
|
Prescription Drug (Rx)
|
2 mL LDPE ampoule x 5's in aluminium pouch (Box of 25's)
|
GLUCOCORTICOID
|
Legency Remedies Pvt. Ltd
|
India
|
N/A
|
Suhitas Pharmaceuticals Inc
|
MDB Pharma Trading
|
CLIDP Conversion
|
07 November 2022
|
22 September 2025
|
| View |
|
DRP-9170-03
|
Budesonide
|
Aeoran
|
250 mcg/mL (500 mcg/2 mL)
|
Suspension for Nebulization
|
Prescription Drug (Rx)
|
2 mL LDPE ampoule x 5's in aluminum pouch (Box of 25's)
|
Glucocorticoid
|
Legency Remedies Pvt. Ltd.
|
India
|
N/A
|
Suhitas Pharmaceuticals Inc.
|
Orange Biotec Inc
|
CLIDP Conversion
|
31 December 2022
|
22 September 2025
|