| View |
|
DRP-9569
|
Paracetamol
|
Pyresaph-250
|
250 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-9569-01
|
Paracetamol
|
Pyrexia 250
|
250 mg/5 mL
|
Suspension
|
Over-the-Counter Drug (OTC)
|
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-9569-02
|
Paracetamol
|
Kidiron 250
|
250 mg / 5 mL
|
Suspension
|
Over-the-Counter (OTC) Drug
|
PET Round Amber Bottle with White HDPE Cap x 60 mL (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 2026
|
| View |
|
DRP-9569-03
|
Paracetamol
|
Acetamol-250
|
250 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
|
10 January 2024
|
26 February 2026
|
| View |
|
DRP-9570
|
Aluminum Hydroxide + Magnesium Hydroxide
|
Calmsaph-S21
|
200mg/100mg/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.
|
|
-
|
26 February 2021
|
26 February 2026
|
| View |
|
DRP-9571
|
Carbocisteine
|
Carbosaph-200
|
200mg/5mL
|
Syrup
|
Over-the-Counter (OTC) Drug
|
PET Round Amber Bottle with White HDPE Cap x 60 mL and 120 mL (Box of 1's)
|
-
|
Azine Healthcare Pvt. Ltd.
|
India
|
Sapphire Lifesciences Pvt. Ltd.
|
Nelpa Lifesciences, Inc.
|
|
-
|
26 February 2021
|
26 February 2026
|
| View |
|
DRP-9572
|
Carbocisteine
|
Carbosaph-125
|
125mg/5mL
|
Syrup
|
Over-the-Counter (OTC) Drug
|
PET Round Amber Bottle with White HDPE Cap x 60 mL and 120 mL (Box of 1's)
|
-
|
Azine Healthcare Pvt. Ltd.
|
India
|
Sapphire Lifesciences Pvt. Ltd.
|
Nelpa Lifesciences, Inc.
|
|
-
|
26 February 2021
|
26 February 2026
|
| View |
|
DRP-9573
|
Paracetamol
|
Parasaph-125
|
125mg/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.
|
|
-
|
26 February 2021
|
26 February 2026
|
| View |
|
DRP-9574
|
Paracetamol
|
Parasaph-250
|
250 mg/ 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.
|
|
-
|
26 February 2021
|
26 February 2026
|
| View |
|
DRP-9575
|
Phenylpropanolamine Hydrochloride + Chlorphenamine Maleate
|
Phenchlor
|
12.5 mg/2 mg per 5 mL Syrup
|
Syrup
|
Over-the-Counter (OTC) Drug
|
Type III Boston Round Amber Bottle Sealed with PP Aluminum Cap x 60's (Box of l's)
|
-
|
Sydenham Laboratories, Inc.
|
Philippines
|
|
|
|
-
|
02 March 2021
|
02 March 2026
|
| View |
|
DRP-9576
|
Amikacin (As Sulfate)
|
Ekacin
|
250mg/mL(500mg/2mL)
|
Solution For Injection/Infusion (I.M./I.V.)
|
Prescription Drug (RX)
|
USP Type I amber colour glass ampoule x 2 mL
(net content). Box of 5's and 10's)
|
-
|
CSPC Ouyi Pharmaceutical Co. Ltd.
|
China
|
|
AMB HK Enterprises Inc.
|
AMB HK Enterprises Inc.
|
-
|
03 March 2021
|
03 March 2026
|
| View |
|
DRP-9577
|
Levocetirizine Dihydrochloride (Grape Flavor)
|
None
|
5mg/mL
|
Solution (Oral Drops)
|
Prescription Drug (RX)
|
15 mL-capacity Amber Glass Bottle with Aluminum Cap (Box of 1's)
|
-
|
Life Square Laboratories Inc.
|
Philippines
|
|
|
|
-
|
04 March 2021
|
04 March 2026
|
| View |
|
DRP-9578
|
Sitagliptin Phosphate + Metformin Hydrochloride
|
Janumet XR
|
100mg / 1g
|
Extended Release Film Coated Tablet
|
Prescription Drug (RX)
|
White HDPE Plastic Bottle x 28's and 30's; White
HDPE Plastic Bottle x 7's (as Physician's Sample)
|
-
|
MSD International GmbH (Puerto Rico Branch) LLC
|
Puerto Rico
|
|
Merck Sharp & Dohme (1.A.) LLC
|
|
Initial
|
04 March 2021
|
04 March 2026
|
| View |
|
DRP-9579
|
Levetiracetam
|
Lecitram
|
100 mg/ mL (500 mg/5 mL)
|
Solution for Injection (IV Infusion)
|
Prescription Drug (RX)
|
5 mL USP Type I clear transparent glass vial along with grey bromobutyl rubber stopper and orange aluminum flip-off seal (Box of 25's)
|
-
|
Gland Pharma Limited
|
India
|
|
Pharma-Surrey International, Inc.
|
Pharma-Surrey International, Inc.
|
-
|
05 March 2021
|
05 March 2026
|
| View |
|
DRP-9580
|
Timolol (as Maleate)
|
Lutimol
|
5 mg/mL (0.5% w/v)
|
Ophthalmic Solution (Eye Drops)
|
Prescription Drug (RX)
|
5 mL LDPE vial (Box of 1's)
|
-
|
Axa Parenterals Limited
|
India
|
|
S.M.H.P. Marketing & Consultancy
|
S.M.H.P. Marketing & Consultancy
|
-
|
05 March 2021
|
05 March 2026
|
| View |
|
DRP-9581
|
Latanoprost
|
Latochek
|
50 mcg/mL (0.005% w/v)
|
Ophthalmic Solution (Eye Drops)
|
Prescription Drug (Rx)
|
5 mL LDPE Bottle with LDPE Nozzle and White HDPE Cap (Net content: 2.5 mL) (Box of 1's)
|
-
|
Indoco Remedies Limited
|
India
|
|
Ambica International Corporation
|
Ambica International Corporation
|
-
|
26 February 2021
|
26 February 2026
|
| View |
|
DRP-9582
|
Ascorbic Acid + Zinc +Cholecalciferol (Vitamin D3)
|
Elite-CDZ
|
500 mg (equivalent to 562.43 mg Sodium Ascorbate)/ 10 mg (equivalent to 70 mg Zinc Gluconate)/1,000 IU
|
Capsule
|
Over-the-Counter (OTC)
|
Alu/PVC-PVDC Amber Colored Blister Pack x 10's (Box
of 100's)
|
-
|
Lloyd Laboratories, Inc.
|
Philippines
|
Gold Life Distribution Phils. Inc.
|
|
|
-
|
02 March 2021
|
02 March 2026
|
| View |
|
DRP-9583
|
Atorvastatin ( As Calcium )
|
Avas
|
40 mg
|
Film-Coated Tablet
|
Prescription Drug (Rx)
|
Alu/Alu Blister Pack x 10's (Box of 30's)
|
Antihyperlipidemia (HMG-CoA Reductase Inhibitor)
|
Micro Labs Limited
|
India
|
N/A
|
Brown & Burk Phils., Inc.
|
Brown & Burk Phils., Inc.
|
Automatic Renewal
|
05 July 2023
|
23 October 2028
|
| View |
|
DRP-9583-01
|
Atorvastatin (as calcium)
|
None
|
40 mg
|
Film Coated Tablet
|
Prescription Drug (Rx)
|
Alu/Alu Blister Pack x 10's / (Box of 30's)
|
Antihyperlipidemia (HMG-CoA Reductase Inhibitor)
|
Micro Labs Limited
|
India
|
|
Brown & Burk Philippines Inc
|
ADP Pharma Corporation
|
CLIDP Conversion
|
23 June 2024
|
23 October 2028
|
| View |
|
DRP-9584
|
Ascorbic acid (as Sodium ascorbate)
|
Sa-Cee
|
500mg (eq. to 562.43mg Sodium Ascorbate)
|
Capsule
|
Over-the-Counter (OTC) Drug
|
Blister pack x 10's / (Box of 100's)
|
Vitamin
|
Philmed Laboratories, Inc.
|
Philippines
|
|
|
|
CLIDP Conversion
|
11 June 2024
|
06 August 2029
|