| View |
|
DRP-9432
|
Multivitamins
|
Vitasaph-OD
|
See Reverse formulation
|
Syrup (Oral Drops)
|
Over-the-Counter (OTC)
|
PET Round Amber Bottle with White HDPE Cap x 15 mL and 30 mL with Plastic Dropper (Box of l's)
|
-
|
Enicar Pharmaceuticals Pvt. Ltd.
|
India
|
Sapphire Lifesciences Pvt. Ltd.
|
Nelpa Lifesciences, Inc.
|
|
-
|
29 December 2020
|
29 December 2025
|
| View |
|
DRP-9433
|
Multivitamins + Iron
|
Vitronsaph-Fe
|
See Reverse formulation
|
Syrup
|
Over-The-Counter (OTC)
|
60 mL and 120 mL PET Round Amber Bottle with White HDPE Cap
|
Vitamins
|
Enicar Pharmaceuticals Pvt. Ltd.
|
India
|
Sapphire Lifesciences Pvt. Ltd.
|
Nelpa Lifesciences, Inc.
|
|
Initial [OTC]
|
29 December 2020
|
29 December 2025
|
| View |
|
DRP-9434
|
Guaifenesin + Phenylpropanolamine HCI +
Chlorphenamine maleate
|
Deconsaph-Plus
|
100 mg/6.5 mg/2 mg per 5 mL
|
Syrup
|
Over-the-Counter (OTC)
|
PET Round Amber Bottle with White HDPE Cap x 60 mL and 120 mL (Box of l's)
|
-
|
Enicar Pharmaceuticals Pvt. Ltd.
|
India
|
Sapphire Lifesciences Pvt. Ltd.
|
Nelpa Lifesciences, Inc.
|
|
-
|
29 December 2020
|
29 December 2025
|
| View |
|
DRP-9435
|
Guaifenesin + Phenylpropanolamine HCl +
Chlorphenamine maleate
|
Decosaph
|
100 mg/5 mg/2 mg per 5 mL
|
Syrup
|
Over-the-Counter (OTC)
|
PET Round Amber Bottle with White HDPE Cap x 60 mL and 120 mL (Box of l's)
|
-
|
Enicar Pharmaceuticals Pvt. Ltd.
|
India
|
Sapphire Lifesciences Pvt. Ltd.
|
Nelpa Lifesciences, Inc.
|
|
-
|
29 December 2020
|
29 December 2025
|
| View |
|
DRP-9436
|
Diphenhydramine Hydrochloride
|
Saphdramine
|
12.5mg/5mL
|
Syrup
|
Over-the-Counter (OTC)
|
PET Round Amber Bottle with White HDPE Cap x 60 mL and 120 mL (Box of l's)
|
-
|
Enicar Pharmaceuticals Pvt. Ltd.
|
India
|
Sapphire Lifesciences Pvt. Ltd.
|
Nelpa Lifesciences, Inc.
|
|
-
|
29 December 2020
|
29 December 2025
|
| View |
|
DRP-9437
|
Phenylpropanolamine Hcl
|
Saphnolamine-OD
|
6.25 mg
|
Syrup (Oral Drops)
|
Over-the-Counter (OTC)
|
PET Round Amber Bottle with White HDPE Cap x 15 mL and 30 mL with Plastic Dropper (Box of l's)
|
-
|
Enicar Pharmaceuticals Pvt. Ltd.
|
India
|
Sapphire Lifesciences Pvt. Ltd.
|
Nelpa Lifesciences, Inc.
|
|
-
|
29 December 2020
|
29 December 2025
|
| View |
|
DRP-9438
|
Hyoscine-N-Butylbromide
|
Saphyoscine
|
1mg/mL
|
Syrup
|
Over-the-Counter (OTC)
|
PET Round Amber Bottle with White HDPE Cap x 60 mL and 120 mL (Box of l's)
|
-
|
Enicar Pharmaceuticals Pvt. Ltd.
|
India
|
Sapphire Lifesciences Pvt. Ltd.
|
Nelpa Lifesciences, Inc.
|
|
-
|
29 December 2020
|
29 December 2025
|
| View |
|
DRP-9439
|
Multivitamins + Buclizine HCl + Iron
|
Appesaph
|
Each Capsule contains
Thiamine Mononitrate (Vitamin B1)-10mg Pyridoxine HCl (Vitamin B6)-5mg Cyanocobalamin (Vitamin B12)-10mcg Buclizine HCI-25mg Iron-25mg (equivalent to 76.06 mg Ferrous Fumarate)
|
Capsule
|
Over-the-Counter (OTC) Drug
|
Alu/Foil Strip Pack x 10's (Box of 100's)
|
-
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
|
Nelpa Lifesciences, Inc.
|
|
-
|
25 January 2021
|
25 January 2026
|
| View |
|
DRP-944
|
Sterile Water For Injection
|
None
|
None
|
None
|
Prescription Drug (Rx)
|
Type I glass vial x 10 mL, 20 mL, 50 mL, and 100 mL /
|
Parenteral
|
Best Drug Industries, Inc
|
Philippines
|
|
|
|
Renewal
|
09 March 2024
|
23 February 2030
|
| View |
|
DRP-944-01
|
Sterile Water For Injection
|
None
|
None
|
None
|
Prescription Drug (RX)
|
Type I Glass Vial x 20mL, 50mL, and 100mL
|
-
|
Best Drug Industries, Inc.
|
Philippines
|
|
|
Quinosil Laboratory, Inc.
|
-
|
29 September 2021
|
23 February 2025
|
| View |
|
DRP-9440
|
Amiodarone Hydrochloride
|
Anoion
|
200 mg
|
Tablet
|
Prescription Drug (RX)
|
Alu/Clear PVDC Blister Pack x 10's (Box of 50's)
|
ANTI-ARRHYTHMIC
|
LLOYD LABORATORIES, INC.
|
Philippines
|
GX International, Inc.
|
|
|
Renewal
|
20 May 2022
|
19 December 2027
|
| View |
|
DRP-9441-01
|
Sitagliptin (as phosphate monohydrate)
|
Lupigliptin
|
50 mg
|
Film-Coated Tablet
|
Prescription Drug (Rx)
|
Alu/White Opaque PVC Blister Pack x 10's (Box of 30's)
|
Dipeptidyl Peptidase-4 Inhibitor
|
Lloyd Laboratories, Inc.
|
Philippines
|
Solvang Pharmaceuticals, Inc.
|
N/A
|
Medspecialty, Inc
|
Renewal
|
21 April 2022
|
17 April 2027
|
| View |
|
DRP-9442
|
Quetiapine (As Fumarate)
|
Psycopin
|
100 mg
|
Film-Coated Tablet
|
Prescription Drug (RX)
|
Alu/Whilte PV Blister Pack x 10's
(Box of 60's)
|
Antipsychotic
|
Lloyd Laboratories, Inc.
|
Philippines
|
|
|
|
Automatic Renewal
|
15 March 2021
|
03 March 2026
|
| View |
|
DRP-9443-01
|
Thiamine Mononitrate (Vitamin B1) + Pyridoxine Hydrochloride (Vitamin B6) + Cyanocobalamin (Vitamin B12)
|
None
|
Each capsule contains: Thiamine Mononitrate (Vitamin B1)-100mg Pyridoxine Hydrochloride (Vitamin B6)-5mg Cyanocobalamin (Vitamin B12)-50mcg
|
Capsule
|
Over-the-Counter (OTC)
|
Red PVC Blister Pack x 10's (Box of 100's)
|
Vitamin
|
Lloyd Laboratories, Inc.
|
Philippines
|
Innogen Pharmaceuticals, Inc.
|
|
St. Joseph Drugstore
|
Automatic Renewal
|
14 March 2022
|
03 March 2027
|
| View |
|
DRP-9444
|
Paracetamol
|
Unbranded
|
150mg/mL (750mg/5mL)
|
Solution For Injection (Iv)
|
Prescription Drug (RX)
|
Amber Glass Ampoule x 2 mL and 5 mL (Box of 10's)
|
Analgesic/Antipyretic (Anilide)
|
CSPC Ouyi Pharmaceutical Co., Ltd.
|
China
|
|
AMB HK Enterprises, Inc.
|
AMB HK Enterprises, Inc.
|
Renewal
|
22 November 2023
|
26 March 2029
|
| View |
|
DRP-9445
|
Phytomenadione
|
Ambivit K
|
10mg/mL
|
Solution For Injection (Im/Iv/Sc)
|
Prescription Drug (RX)
|
Amber Glass Ampoule x 1 mL (Box of 50's)
|
Hemostatic
|
CSPC Ouyi Pharmaceutical Co., Ltd.
|
China
|
|
AMB HK Enterprises, Inc.
|
AMB HK Enterprises, Inc.
|
Initial (Variation: PCPR Conversion)
|
05 January 2021
|
09 January 2025
|
| View |
|
DRP-9445-01
|
Phytomenadione
|
Vitaden K
|
10 mg / mL
|
Solution for Injection (IM/IV/SC)
|
Prescription Drug (Rx)
|
Amber Glass Ampoule x 1 mL (Box of 5's; Box of 10's and Box of 50's)
|
Hemostatic
|
Farbe Firma Pvt. Ltd
|
India
|
N/A
|
AMB HK Enteprises Inc.
|
Cyden Medicale Trading Inc.
|
CLIDP Conversion
|
16 November 2023
|
09 January 2025
|
| View |
|
DRP-9445-02
|
Phytomenadione
|
Phytovue
|
10 mg / mL
|
Solution for Injection (IM/IV/SC)
|
Prescription Drug (Rx)
|
Amber Glass Ampoule x 1 mL (Box of 10’s)
|
Hemostatic
|
Farbe Firma
|
India
|
N/A
|
AMB HK Enterprises, Inc
|
CV Clearvue Pharma, Inc
|
CLIDP Conversion
|
03 December 2023
|
09 January 2025
|
| View |
|
DRP-9446
|
Zoledronic Acid
|
Zobone 5
|
5 mg/100 mL
|
Solution for Injection (I.V. Infusion)
|
Prescription Drug (Rx)
|
100 mL Type I Colorless Molded Infusion Vial with Grey Rubber Stopper and Flip-off Golden Red Aluminum Seal
|
Bisphosphonate
|
Sun Pharmaceutical Industries Limited
|
India
|
N/A
|
Sun Pharma Philippines, Inc.
|
Sun Pharma Philippines, Inc
|
Renewal
|
19 February 2023
|
13 August 2028
|
| View |
|
DRP-9447
|
Salbutamol
|
Salbumin
|
100mcg/dose (200 doses per container) Metered Inhaler Dose
|
Metered Inhaler Dose
|
Prescription Drug (RX)
|
Aluminum Canister (Box of l's)
|
-
|
Weifang Zhongshi Pharmaceutical Co., Ltd.
|
China
|
|
AMB HK Enterprises, Inc.
|
AMB HK Enterprises, Inc.
|
-
|
05 January 2021
|
06 September 2024
|