| View |
|
DRP-9557
|
Cyproterone Acetate + Ethinylestradiol
|
Suncet 35
|
2 mg/35 mcg
|
Film-Coated Tablet
|
Prescription Drug (RX)
|
Alu-Clear PVC Blister Pack x 21's (Box of 21's)
|
-
|
Sun Pharmaceutical Industries Ltd.
|
India
|
|
Sun Pharma Philippines, Inc.
|
Sun Pharma Philippines, Inc.
|
-
|
08 March 2021
|
08 March 2026
|
| View |
|
DRP-9558
|
Moxifloxacin (as hydrochloride)
|
Axqin
|
1.6 mg/mL (400 mg/250 mL)
|
Solution for Intravenous
Infusion
|
Prescription Drug (Rx)
|
LDPE Bottle with white dust cap x 250 mL (Box of 1's)
|
Antibacterial (Fluoroquinolone)
|
Axa Parenterals Limited
|
India
|
|
Brady Pharma Inc.
|
Brady Pharma Inc.
|
Initial (Reconstruction)
|
12 August 2024
|
30 April 2026
|
| View |
|
DRP-9559
|
Paracetamol + Guaifenesin + Phenylpropanolamine
Hydrochloride + Dextromethorphan Hydrobromide +
Chlorphenamine Maleate
|
RAPHCTUSS
|
325mg/50mg/12.5mg/10mg/1mg
|
Capsule
|
Over-The-Counter (OTC) Drug
|
Alu-Strip Foil Pack x 10's (Box of 100's)
|
-
|
Azarias Pharmaceutical Laboratories Inc.,
|
Philippines
|
St. Raphael, The Archangel Pharmaceutical Distributor
|
|
|
-
|
24 February 2021
|
24 February 2026
|
| View |
|
DRP-956-06
|
CEFALEXIN (AS MONOHYDRATE)
|
Unbranded
|
125mg/5mL
|
Powder For Suspension
|
Prescription Drug (RX)
|
Boston Round Amber Bottle x 60ml (Box of 1's)
|
ANTIBACTERIAL (CEPHALOSPORIN)
|
J.M. Tolamnn Laboratories Inc.
|
Philippines
|
|
|
999 Seth Pharmaceuticals, Inc.
|
Renewal
|
13 December 2023
|
12 January 2029
|
| View |
|
DRP-9560
|
Ascorbic Acid
|
None
|
500mg (equivalent to 562.43mg Sodium Ascorbate)
|
Capsule
|
Over-the-counter (OTC) Drug
|
Alu/Red PVC Blister Pack x 10's (Box of 100's)
|
-
|
Philmed Laboratories Inc.
|
Philippines
|
|
|
|
-
|
24 February 2021
|
24 February 2026
|
| View |
|
DRP-9561
|
Ketoanalogues + Essential Amino Acids
|
Renabal
|
Each film-coated tablet contains: Calcium-4-methyl-2-oxo-valerate (a-ketoanalogue to leucine, calcium salt)-101 mg Calcium-3-methyl-2-oxo-butyrate (a-ketoanalogue to valine, calcium salt)-86 mg Calcium-2-oxo-3-phenylpropionate (a-ketoanalogue to phenylalanine, calcium salt)- 68 mg Calcium-3-methyl-2-oxo-valerate (a-ketoanalogue to isoleucine, calcium salt)-67 mg Calcium-DL-2-hydroxy-4-(methylthio) butyrate (a-hydroxynalogue to methionine, calcium salt)-59 mg
L-Lysine Acetate-105 mg L-Threonine-53 mg L-Histidine-38 mg L-Tyrosine-30 mg L-Tyrptophan-23 mg
|
Film-Coated Tablet
|
Prescription Drug (RX)
|
Aluminum Foil Strip Pack x 10's (Box of 100's)
|
-
|
Stallion Laboratories Pvt. Ltd.
|
India
|
|
Ambica International Corporation
|
Ambica International Corporation
|
-
|
24 February 2021
|
24 February 2026
|
| View |
|
DRP-9562
|
Ketoanalogues + Essential Amino Acids
|
Avodial
|
Each film-coated tablet contains: Calcium-4-methyl-2-oxo-valerate (a-ketoanalogue to leucine, calcium salt)-101 mg Calcium-3-methyl-2-oxo-butyrate (a-ketoanalogue to valine, calcium salt)-86 mg Calcium-2-oxo-3-phenylpropionate (a-ketoanalogue to phenylalanine, calcium salt)-68 mg Calcium-3-methyl-2-oxo-valerate (a-ketoanalogue to isoleucine, calcium salt)-67 mg Calcium-DL-2-hydroxy-4-methylthio) butyrate (a-hydroxynalogue to methionine, calcium salt)-59 mg
L-Lysine Acetate-105 mg L-Threonine-53 mg L-Histidine-38 mg L-Tyrosine-30 mg L-Tyrptophan-23 mg
|
Film-Coated Tablet
|
Prescription Drug (RX)
|
Aluminum Foil Strip Pack x 10's (Box of 100's)
|
-
|
Stallion Laboratories Pvt. Ltd.
|
India
|
|
Ambica International Corporation No.9
|
Ambica International Corporation No.9
|
-
|
24 February 2021
|
24 February 2026
|
| View |
|
DRP-9562-01
|
Ketoanalogues + Essential Amino Acids
|
Ketorels
|
(See reverse for unit dose formulation)
|
Film-Coated Tablet
|
Prescription Drug (Rx)
|
Aluminum Foil Strip Pack x 10's (Box of 100's)
|
Renal Nutrition Therapy
|
Stallion Laboratories Pvt. Ltd.
|
India
|
N/A
|
Ambica International Corporation
|
Scriptmed, Inc
|
CLIDP Conversion
|
20 October 2022
|
24 February 2026
|
| View |
|
DRP-9563
|
Gemcitabine (as hydrochloride)
|
Gemcitrex-200
|
200 mg
|
Lyophilized Powder for Injection for I.V. Infusion
|
Prescription Drug (RX)
|
Type I glass vial with grey bromobutyl stopper and aluminum flip-off lemon yellow colour seal (Box of l's)
|
-
|
Shilpa Medicare Limited
|
India
|
|
Ambica International Corporation
|
Ambica International Corporation
|
-
|
24 February 2021
|
24 February 2026
|
| View |
|
DRP-9564
|
Gemcitabine (as hydrochloride)
|
Gemcitrex-1000
|
1 g
|
Lyophilized Powder for Injection for I. V. Infusion
|
Prescription Drug (RX)
|
Type I glass vial with grey bromobutyl stopper and aluminum flip-off lemon yellow colour seal (Box of l's)
|
-
|
Shilpa Medicare Limited
|
India
|
|
Ambica International Corporation
|
Ambica International Corporation
|
-
|
03 March 2021
|
03 March 2026
|
| View |
|
DRP-9565
|
Carbocisteine
|
Saphcisin 500
|
500mg/5mL
|
Suspension
|
Over-the-Counter (OTC) Drug
|
PET Round Amber Bottle with White HDPE Cap x 60 mL and 120 mL (Box of 1's)
|
-
|
Enicar Pharmaceuticals Pvt. Ltd.
|
India
|
Sapphire Lifesciences Pvt. Ltd.
|
Nelpa Lifesciences, Inc.
|
|
-
|
26 February 2021
|
26 February 2026
|
| View |
|
DRP-9566
|
Paracetamol
|
Pyresaph-125
|
125mg/5mL
|
Suspension
|
Over-The-Counter (OTC)
|
PET Round Amber Bottle with White HDPE Cap x 60 mL and 120 mL
|
-
|
Enicar Pharmaceuticals Pvt. Ltd.
|
India
|
Sapphire Lifesciences Pvt. Ltd.
|
Nelpa Lifesciences, Inc.
|
|
Initial (OTC)
|
26 February 2021
|
26 February 2026
|
| View |
|
DRP-9566-01
|
Paracetamol
|
Pyrexia 125
|
125 mg/5 mL
|
Suspension
|
Over-the-Counter (OTC) Drug
|
PET Round Amber Bottle with White HDPE Cap x 60 mL and 120 mL (Box of 1's)
|
Analgesic/Antipyretic
|
Enicar Pharmaceuticals Pvt. Ltd
|
India
|
N/A
|
Nelpa Lifesciences, Inc.
|
Kaufmann Pharma Inc
|
CLIDP Conversion
|
19 January 2023
|
26 February 2026
|
| View |
|
DRP-9566-02
|
Paracetamol
|
Kidiron 125
|
125 mg/5 mL
|
Suspension
|
Over-the-Counter (OTC) Drug
|
PET Round Amber Bottle with HDPE Cap x 60 mL and 120 mL (Box of 1’s)
|
Analgesic/Antipyretic
|
Enicar Pharmaceuticals Pvt. Ltd.
|
India
|
N/A
|
Nelpa Lifesciences, Inc
|
Kaufmann Pharma Inc.
|
CLIDP Conversion
|
31 December 2023
|
26 February 2026
|
| View |
|
DRP-9566-03
|
Paracetamol
|
Acetamol-125
|
125 mg/5 mL
|
Suspension
|
Over-the-Counter (OTC) Drug
|
PET Round Amber Bottle with White HDPE Cap x 60 mL and 120 mL (Box of 1’s)
|
Analgesic/Antipyretic
|
Enicar Pharmaceuticals Pvt. Ltd
|
India
|
N/A
|
Nelpa Lifesciences, Inc
|
777 Red Pharma Inc.
|
CLIDP Conversion
|
09 January 2024
|
26 February 2026
|
| View |
|
DRP-9567
|
Paracetamol
|
Pyresaph-120
|
120 mg/ 5mL
|
Suspension
|
Over-The-Counter (OTC)
|
PET Round Amber Bottle with white HDPE Cap x 60 ml and 120 ml
|
-
|
Enicar Pharmaceuticals Pvt. Ltd.
|
India
|
Sapphire Lifesciences Pvt. Ltd.
|
Nelpa Lifesciences, Inc.
|
|
Initial (OTC)
|
26 February 2021
|
26 February 2026
|
| View |
|
DRP-9568
|
Paracetamol
|
Pyresaph-OD
|
100mg/mL
|
Suspension (Oral Drops)
|
Over-the-Counter (OTC) Drug
|
PET Round Amber Bottle with White HDPE Cap X 15 mL and 30 mL with Plastic Dropper (Box of 1's)
|
Analgesics/Antipyretic
|
Enicar Pharmaceuticals Pvt. Ltd.
|
India
|
Sapphire Lifesciences Pvt. Ltd.
|
Nelpa Lifesciences, Inc.
|
|
-
|
26 February 2021
|
26 February 2026
|
| View |
|
DRP-9568-01
|
Paracetamol
|
Pyrexia 100
|
100 mg/mL
|
Suspension (Oral Drops)
|
Over-the-Counter (OTC) Drug
|
PET Round Amber Bottle with White HDPE Cap x 15 mL and 30 mL with Plastic Dropper (Box of 1's)
|
-
|
Enicar Pharmaceuticals Pvt. Ltd.
|
India
|
N/A
|
Nelpa Lifesciences, Inc.
|
Kaufmann Pharma Inc
|
CLIDP Conversion
|
30 January 2023
|
26 February 2026
|
| View |
|
DRP-9568-02
|
Paracetamol
|
Kidiron 100
|
100 mg/mL
|
Suspension (Oral Drops)
|
Over-the-Counter (OTC) Drug
|
PET Round Amber Bottle with White HDPE Cap x 30 mL with Plastic Dropper (Box of 1’s)
|
Analgesic/Antipyretic
|
Enicar Pharmaceuticals Pvt. Ltd
|
India
|
N/A
|
Nelpa Lifesciences, Inc
|
Kaufmann Pharma Inc.
|
CLIDP Conversion
|
04 January 2024
|
26 February 2025
|
| View |
|
DRP-9568-03
|
Paracetamol
|
Acetamol-D
|
100 mg/ mL
|
Suspension (Oral Drops)
|
Over-the-Counter (OTC) Drug
|
PET Round Amber Bottle with White HDPE Cap x 15 mL and 30 mL with Plastic Dropper (Box of 1’s)
|
Analgesic/Antipyretic
|
Enicar Pharmaceuticals Pvt. Ltd.
|
India
|
N/A
|
Nelpa Lifesciences, Inc.
|
777 Red Pharma Inc
|
CLIDP Conversion
|
10 January 2024
|
26 February 2026
|