View |
|
DRP-9105
|
10% Dextrose In Water For Injection
|
None
|
10 g/100 mL (10% w/v)
|
Solution For Injection (Intravenous Infusion)
|
Prescription Drug (RX)
|
LDPE bottle x 500 mL and 1000 mL
|
Parenteral Rehydration Solution
|
Albert David Ltd.
|
India
|
|
MedEthix, Inc.
|
|
Automatic Renewal
|
01 February 2022
|
23 October 2027
|
View |
|
DRP-9105-01
|
10% Dextrose In Water For Injection
|
None
|
10 g/100 mL (10% w/v)
|
Solution for IV Injection
(Intravenous Infusion)
|
Prescription Drug (RX)
|
LDPE Plastic Bottle x 500 mL and 1000 mL
|
Parenteral Rehydration Solution
|
Albert David Limited
|
India
|
|
MedEthix, Inc.
|
I.E. Medica, Inc.
|
Automatic Renewal
|
16 March 2022
|
23 October 2027
|
View |
|
DRP-9106
|
Celecoxib
|
Brexen
|
200 mg
|
Capsule
|
Prescription Drug (Rx)
|
Alu-PVC/PVDC Blister Pack x 10 (Box of 100's)
|
-
|
Titan Laboratories Pvt Ltd
|
India
|
Xeno Pharmaceuticals Philippines Inc
|
Stangen Pharmaceuticals Pvt. Ltd.
|
Xeno Pharamceuticals Philippines, Inc.
|
-
|
10 September 2020
|
10 September 2025
|
View |
|
DRP-9107
|
Fusidic Acid + Betamethasone (as Valerate)
|
None
|
20 mg / 1 mg per gram (2% / 0.1% w/w/ )
|
Cream
|
Prescription Drug (Rx)
|
Aluminum collapsible tube with conical white PE cap x 15g
|
Antibacterial/Corticosteroid
|
Encube Ethicals Pvt. Ltd.
|
India
|
|
I.E. Medica, Inc.
|
I.E. Medica, Inc.
|
Initial
|
10 September 2020
|
10 September 2025
|
View |
|
DRP-9107-01
|
Fusidic acid + Betamethasone (as valerate)
|
Fuziem-B
|
20 mg/1 mg per gram (2%/0.1% w/w)
|
Cream
|
Prescription Drug (Rx)
|
Aluminum collapsible tube with conical white PE cap x 15 g (Box of 1's)
|
-
|
Encube Ethicals Pvt. Ltd.
|
India
|
N/A
|
I.E. Medica, Inc
|
MedEthix, Inc
|
CLIDP Conversion
|
21 November 2022
|
10 September 2025
|
View |
|
DRP-9108
|
Fusidic Acid + Betamethasone (as Valerate)
|
Bactafuz-B
|
20 mg / 1 mg per gram (2% / 0.1% w/w/ )
|
Cream
|
Prescription Drug (Rx)
|
Aluminum collapsible tube with conical white PE cap x 15g and 5 g
|
-
|
Encube Ethicals Pvt. Ltd.
|
India
|
|
I.E. Medica, Inc.
|
I.E. Medica, Inc.
|
Initial
|
10 September 2020
|
10 September 2025
|
View |
|
DRP-9109
|
Methyldopa (As Sesquihydrate)
|
Doparine
|
250 mg
|
Film-Coated Tablet
|
Prescription Drug (Rx)
|
Alu/Poly Foil Strip x 10's ( Box of 100's)
|
-
|
Lloyd Laboratories, Inc.
|
Philippines
|
Vamsler Phils. Incorporated
|
|
|
-
|
14 September 2020
|
14 September 2025
|
View |
|
DRP-9110
|
Methyldopa (As Sesquihydrate)
|
Dopalink
|
250 mg
|
Film-Coated Tablet
|
Prescription Drug (Rx)
|
Alu/Poly Foil Strip x 10's (Box of 100's)
|
-
|
Lloyd Laboratories, Inc.
|
Philippines
|
Vitalink Health Products, Inc.
|
|
|
-
|
14 September 2020
|
14 September 2025
|
View |
|
DRP-9111
|
Methyldopa (As Sesquihydrate)
|
Hymet
|
250 mg
|
Film-Coated Tablet
|
Prescription Drug (Rx)
|
Alu/Poly Foil Strip x 10's
|
-
|
Lloyd Laboratories, Inc.
|
Philippines
|
Westfield Pharamceuticals, Inc.
|
|
|
-
|
14 September 2020
|
14 September 2025
|
View |
|
DRP-9112
|
Methyldopa (As Sesquihydrate)
|
Dopacare
|
250 mg
|
Film-Coated Tablet
|
Prescription Drug (Rx)
|
Alu/Poly Foil Strip x 10's (Box of 100's)
|
-
|
Lloyd Laboratories, Inc.
|
Philippines
|
Totalcare Pharma Inc.
|
|
|
-
|
14 September 2020
|
14 September 2025
|
View |
|
DRP-9113
|
Cisplatin
|
Cilatin 50
|
1 mg/mL (50 mg/50 mL)
|
Solution for Injection (IV
|
Prescription Drug (RX)
|
60 ml-capacity USP Type 1 amber glass vial with 20 mm gray rubber stopper and 20 mm purple aluminum
flip off seal x 50 mL (Box of i's)
|
-
|
Hetero Labs Limited
|
India
|
|
Camber Pharmaceuticals, Inc.
|
Camber Pharmaceuticals, Inc.
|
Initial
|
02 October 2020
|
02 October 2025
|
View |
|
DRP-9114
|
Carboplatin
|
Carbol-450
|
10mg/mL 450 mg/ 45 mL
|
Solution for Intravenous
Infusion
|
Prescription Drug (RX)
|
50 mL Clear Glass Vial (Type I) with bromo butyl rubber stopper and Black Aluminum flip-off seal closure
|
Antineoplastic
|
Venus Remedies Limited
|
India
|
|
Bliss Pharma Distribution and Consultancy Corp.
|
Bliss Pharma Distribution and Consultancy Corp.
|
Initial
|
06 October 2020
|
06 October 2025
|
View |
|
DRP-9114-01
|
Carboplatin
|
Afreplatin
|
10mg/mL (450mg/45mL)
|
Solution For Intravenous Infusion
|
Prescription Drug (RX)
|
50 mL-capacity USP Type I clear glass vial with bromo butyl rubber stopper and black aluminum flip-off seal (Box of 1's)
|
Antineoplastic
|
Venus Remedies Limited
|
India
|
N/A
|
Bliss Pharma Distribution and Consultancy Corp.
|
Afree Pharmaceutical Distribution Corp
|
CLIDP
|
24 January 2022
|
06 October 2025
|
View |
|
DRP-9114-02
|
Carboplatin
|
Carbofree
|
10mg/mL (450mg/45mL)
|
Solution for Intravenous Infusion
|
Prescription Drug (Rx)
|
50mL-capacity USP Type I clear glass vial with bromobutyl rubber stopper and black aluminum flip-off seal (Box of 1's)
|
-
|
Venus Remedies, Limited
|
India
|
N/A
|
Bliss Pharma Distribution and Consultancy Corp.
|
Afree Pharmaceutical Distribution Corp
|
CLIDP Conversion
|
28 November 2022
|
06 October 2025
|
View |
|
DRP-9115
|
Dexamethasone + Tobramycin
|
Tobladex
|
1 mg/3 mg per mL (0.1 % 0.3% w/v)
|
Sterile Opthalmic Suspension (Eye Drops)
|
Prescription Drug (Rx)
|
LDPE plastic dropper and HDPE opaque white screw tamper-proof cap x 5 mL (Box of 1's)
|
Sterile Ophthalmic Suspension (Eye Drops)
|
ALWIN DMD PHARMACEUTICALs
|
India
|
|
Bliss Pharma Distribution and Consultancy Corp.
|
Bliss Pharma Distribution and Consultancy Corp.
|
-
|
10 September 2020
|
10 September 2025
|
View |
|
DRP-9115-01
|
Dexamethasone + Tobramycin
|
Tobdex Free
|
1mg/3mg per mL (0.1%/0.3% w/v)
|
Sterile Ophthalmic Suspension (Eye Drops)
|
Prescription Drug (RX)
|
8.5 mL Capacity Opaque White Plastic Bottle with LDPE Plastic Dropper and HDPE Opaque White Screw Tamper-proof Cap x 5 mL (Box of 1's)
|
-
|
Alwin DMD Pharmaceuticals
|
India
|
|
Bliss Pharma Distribution and Consultancy Corp.
|
Afree Pharmaceutical Distribution Corp
|
-
|
17 September 2021
|
10 September 2025
|
View |
|
DRP-9115-02
|
Dexamethasone + Tobramycin
|
Aguadexa
|
1 mg / 3 mg per mL (0.1% / 0.3% w/v)
|
|
Prescription Drug (Rx)
|
8.5 mL - capacity Opaque white plastic bottle with LDPE plastic dropper and HDPE opaque white screw tamperproof cap x 5 mL (Box of 1's)
|
-
|
Alwin DMD Pharmaceuticals
|
India
|
N/A
|
Bliss Pharma Distribution and Consultancy Corp.
|
Agua Visions Trading
|
CLIDP Conversion
|
24 October 2022
|
10 September 2025
|
View |
|
DRP-9116
|
Carboplatin
|
Carbopa-50
|
50 mg/5 mL (10 mg/ mL)
|
Solution For Iv Infusion
|
Prescription Drug (Rx)
|
USP/Ph. Eur. Type I Amber Tubular Glass Vial with 20mm grey rubber stopper and 20 mm royal blue aluminum flip-off seal (Box of 1's)
|
-
|
Intas Pharmaceuticals Limited
|
India
|
|
Accord Healthcare Limited- Philippines Branch Office
|
Accord Healthcare Limited- Philippines Branch Office
|
-
|
10 September 2020
|
10 September 2025
|
View |
|
DRP-9117
|
Valsartan + Hydrochlorothiazide
|
None
|
160mg/10mg
|
Film-Coated Tablet
|
Prescription Drug (Rx)
|
Alu/ Alu Blister pack of 10's (box of 24's)
|
-
|
Lloyd Laboratories, Inc.
|
Philippines
|
Solvang Pharmaceuticals, Inc.
|
|
|
-
|
14 September 2020
|
14 September 2025
|
View |
|
DRP-9118
|
Methyldopa (As Sesquihydrate)
|
None
|
250 mg
|
Film-Coated Tablet
|
Prescription Drug (Rx)
|
Alu/Poly Foil Strip x 10's (Box of 100's)
|
-
|
Lloyd Laboratories, Inc.
|
Philippines
|
Innogen Pharmaceuticals, Inc.
|
|
|
-
|
14 September 2020
|
14 September 2025
|