| View |
|
DRP-9492
|
Sodium Bicarbonate
|
Bicarnate
|
650mg
|
Tablet
|
Over-the-Counter (OTC)
|
HDPE Plastic Bottle with HDPE screw cap x 60's
|
-
|
Azarias Pharmaceutical Laboratories Inc.,
|
Philippines
|
|
|
|
-
|
25 January 2021
|
25 January 2026
|
| View |
|
DRP-9492-01
|
Sodium Bicarbonate
|
None
|
650 mg
|
Tablet
|
Over-the-Counter (OTC)
|
HDPE Plastic Bottle with HDPE Screw Cap x 60's
|
-
|
Azarias Pharmaceutical Laboratories Inc,
|
Philippines
|
|
|
Daily Grace Unlimited, Inc.
|
-
|
21 July 2021
|
25 January 2026
|
| View |
|
DRP-9492-02
|
Sodium Bicarbonate
|
Karbonet
|
650 mg
|
Tablet
|
Over-the-Counter (OTC) Drug
|
HDPE Plastic Bottle x 60's with HDPE Screw Cap
|
Antacid
|
Azarias Pharmaceutical Laboratories Inc
|
Philippines
|
N/A
|
N/A
|
Konzept Convenience and Drug Store Corp
|
-
|
27 June 2022
|
25 January 2026
|
| View |
|
DRP-9493
|
Sodium Bicarbonate
|
Bicarnate
|
325mg
|
Tablet
|
Over-the-counter (OTC) Drug
|
HDPE Plastic Bottle x 60's with HDPE Screw Cap
|
-
|
Azarias Pharmaceutical Laboratories Inc.,
|
Philippines
|
|
|
|
-
|
25 January 2021
|
25 January 2026
|
| View |
|
DRP-9493-01
|
Sodium Bicarbonate
|
None
|
325 mg
|
Tablet
|
Over-the-Counter (OTC)
|
HDPE Plastic Bottle with HDPE Screw Cap x 60's
|
Antacid
|
Azarias Pharmaceutical Laboratories Inc,
|
Philippines
|
|
|
Daily Grace Unlimited, Inc.
|
Initial [CLIDP]
|
21 July 2021
|
25 January 2026
|
| View |
|
DRP-9493-02
|
Sodium Bicarbonate
|
Karbonet
|
325 mg
|
Tablet
|
Over-the-Counter (OTC) Drug
|
HDPE Plastic Bottle x 60's with HDPE Screw Cap
|
Antacid
|
Azarias Pharmaceutical Laboratories Inc
|
Philippines
|
N/A
|
N/A
|
Konzept Convenience and Drug Store Corp
|
-
|
27 June 2022
|
25 January 2026
|
| View |
|
DRP-9494
|
Ascorbic Acid
|
Chewcy
|
Each chewable tablet contains: Ascorbic Acid -200 mg Ascorbic Acid-300 mg (Equivalent to 337.47mg Sodium Ascorbate)
|
Chewable Tablet
|
Over-the-Counter (OTC) Drug
|
Aluminum Foil x 4's (Box of 100's)
|
-
|
La Croesus Pharma, Inc.
|
Philippines
|
|
|
Nutra Berde Incorporated
|
-
|
29 January 2021
|
29 January 2026
|
| View |
|
DRP-9495
|
Multivitamins
|
Vitasaph-Min
|
Formulation Each 5 mL contains: Retinol acetate (Vitamin A)-4000 IU Ergocalciferol (Vitamin D2)-200 IU Ascorbic acid (Vitamin C)-100 mg Nicotinamide (Vitamin B3)-12.5 mg Calcium Pantothenate (Vitamin B5)-10 mg Thiamine HCI (Vitamin B1)-5 mg Riboflavin (Vitamin B2)-5 mg Pyridoxine HCl (Vitamin B6)-5 mg Cyanocobalamin (Vitamin B12)-3 mcg
|
Syrup
|
Over-The-Counter (OTC)
|
PET Round Amber Bottle with White HDPE Cap x 10 mL
(Physician sample);
15 mL (Physician sample) and 250 mL Bottle
|
Vitamins
|
Azine Healthcare Pvt. Ltd.
|
India
|
Sapphire Lifesciences Pvt. Ltd.
|
Nelpa Lifesciences, Inc.
|
|
Initial (OTC)
|
25 January 2021
|
25 January 2026
|
| View |
|
DRP-9496
|
Paracetamol + Ibuprofen
|
Bupasaph-S
|
125 mg/100 mg per 5mL
|
Suspension
|
Over-the-Counter (OTC) Drug
|
PET Round Amber Bottle with White HDPE Cap x 60 mL and 120 mL (Box of l's)
|
-
|
Azine Healthcare Pvt. Ltd.
|
India
|
Sapphire Lifesciences Pvt. Ltd.
|
Nelpa Lifesciences, Inc.
|
|
-
|
25 January 2021
|
25 January 2026
|
| View |
|
DRP-9497
|
Dextromethorphan hydrobromide
|
Saphdex-10
|
10mg/5mL
|
Syrup
|
Over-the-Counter (OTC) Drug
|
PET Round Amber Bottle with White HDPE Cap x 60 mL and 120 mL (Box of l's)
|
-
|
Azine Healthcare Pvt. Ltd.
|
India
|
Sapphire Lifesciences Pvt. Ltd.
|
Nelpa Lifesciences, Inc.
|
|
-
|
25 January 2021
|
25 January 2026
|
| View |
|
DRP-9498
|
Calcium Ascorbate + Zinc
|
Calzeesaph
|
500 mg (equivalent to 605.19 mg Calcium Ascorbate)/
20 mg (equivalent to 55 mg Zinc Sulfate Monohydrate)
|
Capsule
|
Over-the-Counter (OTC) Drug
|
Alu/Dark Maroon Color PVC Blister Pack x 10's
(Box of 100's)
|
-
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
|
Nelpa Lifesciences, Inc.
|
|
-
|
25 January 2021
|
25 January 2026
|
| View |
|
DRP-9499
|
Dextromethorphan hydrobromide
|
Dextrosaph-10
|
10mg/5mL
|
Syrup
|
Over-the-Counter (OTC) Drug
|
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.
|
|
-
|
25 January 2021
|
25 January 2026
|
| View |
|
DRP-950
|
Ceftazidime (As Pentahydrate)
|
Flazidem
|
1g
|
Powder For Injection (Im/Iv)
|
Prescription Drug (RX)
|
Clear glass vial with rubber stopper and white flip off seal
|
Antibacterial (Cephalosporin)
|
flamingo Pharmaceuticals Ltd
|
India
|
|
Hexagon Chemical Corporation
|
Hexagon Chemical Corporation
|
Automatic Renewal
|
27 July 2022
|
23 October 2027
|
| View |
|
DRP-9501
|
Zinc
|
Immunosaph-T30
|
30 mg (equivalent to 233.90 mg Zinc Gluconate Trihydrate)
|
Film Coated Tablet
|
Over-the-Counter (OTC) Drug
|
Alu/Dark Maroon Color PVC Blister Pack x 10's (Box of 100's)
|
-
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
|
Nelpa Lifesciences, Inc.
|
|
-
|
26 January 2021
|
26 January 2026
|
| View |
|
DRP-9500
|
Multivitamins
|
Enersaph
|
Formulation
Each 5mL contains
Retinol Palmitate (Vitamin A) 4,000 IU
Ergocalciferol (Vitamin D2) 200 IU
Ascorbic Acid (Vitamin C) 100 mg
Nicotinamide (Vitamin B3) 12.5 mg
Calcium Pantothenate (Vitamin B5) 10 mg
Thiamine Hydrochloride (Vitamin B1) 5 mg
Riboflavin (Vitamin B2) 5 mg
Pyridoxine Hydrochloride (Vitamin B6) 5 mg
Cyanocobalamin (Vitamin B12) 3 mcg
|
Formulation Each 5mL contains Retinol Palmitate (Vitamin A)-
4,000 IU Ergocalciferol (Vitamin D2 )-
200 IU Ascorbic Acid (Vitamin C)-100mg Nicotinamide (Vitamin B3)-
12.5 mg Calcium Pantothenate (Vitamin B5)-10mg Thiamine Hydrochloride (Vitamin B1)-5mg Riboflavin (Vitamin B2) -5 mg Pyridoxine Hydrochloride (Vitamin B6)-
5 mg Cyanocobalamin (Vitamin B12) -3mcg
|
Over-The-Counter (OTC)
|
PET Round Amber Bottle with White HDPE Cap x 15 mL (Box of 1's) (Physician Sample)
PET Round Amber Bottle with White HDPE Cap x 250 mL (Box of 1's)
|
Vitamins
|
Enicar Pharmaceuticals Pvt. Ltd.
|
India
|
Sapphire Lifesciences Pvt. Ltd.
|
Nelpa Lifesciences, Inc.
|
|
Initial OTC
|
25 January 2021
|
25 January 2026
|
| View |
|
DRP-9502
|
Paracetamol + Ibuprofen
|
Saphyrefen
|
125 mg/100 mg per 5mL
|
Suspension
|
Over-the-Counter (OTC) Drug
|
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.
|
|
-
|
26 January 2021
|
26 January 2026
|
| View |
|
DRP-9503
|
Loratadine
|
Allergo
|
10 mg
|
Tablet
|
Over-the-Counter (OTC)
|
Alu/PVC Clear Blister Pack of 20's (Box of 20's,60's
and 100's)
|
-
|
Phil. United Pharma Corp.
|
Philippines
|
|
|
ATC Healthcare International Corp.
|
-
|
27 January 2021
|
27 January 2026
|
| View |
|
DRP-9504
|
Cefalexin (As Monohydrate)
|
Cefalin
|
125 mg/5 mL
|
Powder For Oral Suspension
|
Prescription Drug (RX)
|
Amber Glass Bottle with Aluminum Pilfer Proof Cap x 60 mL (Box of l's)
|
-
|
Asian Antibiotics, Inc.
|
Philippines
|
UNILAB, Inc.
|
|
|
-
|
27 January 2021
|
31 August 2025
|
| View |
|
DRP-9504-01
|
Cefalexin (As Monohydrate)
|
None
|
125 mg / 5 mL
|
Powder For Oral Suspension
|
Prescription Drug (RX)
|
Amber glass bottle with Aluminum pilfer proof cap x 60 mL (Box of 1's)
|
-
|
Asian Antibiotics, Inc.
|
Philippines
|
|
UNILAB, Inc.
|
Ritemed Philippines, Inc.
|
-
|
07 October 2021
|
31 August 2025
|
| View |
|
DRP-9505
|
Fusidic Acid
|
Fusitas
|
20mg/g (2% w/w)
|
Topical Cream
|
Over-the-Counter (OTC) Drug
|
Laminated Tube x 15g (Box of 1's)
|
-
|
Rhydburg Pharmaceuticals Limited
|
India
|
|
Suhitas Pharmaceuticals Inc.
|
|
-
|
29 January 2021
|
29 January 2026
|