| View |
|
DRP-8760
|
Lamotrigine
|
Lamotrin Odt-100
|
100 mg
|
Oral Dispersible Tablet
|
Prescription Drug (RX)
|
Alu/Alu blister pack x 10's (Box of 30's)
|
-
|
Micro Labs Limited
|
India
|
|
Brown & Burk Phils., Inc.
|
Brown & Burk Phils., Inc.
|
-
|
12 March 2020
|
12 March 2025
|
| View |
|
DRP-8761
|
Lamotrigine
|
Lamotrin Odt -50
|
50 mg
|
Oral Dispersible Tablet
|
Prescription Drug (RX)
|
Alu/Alu blister pack x 10's (Box of 30's)
|
-
|
Micro Labs Limited
|
India
|
|
Brown & Burk Phils., Inc.
|
Brown & Burk Phils., Inc.
|
-
|
12 March 2020
|
12 March 2025
|
| View |
|
DRP-8762
|
Lamotrigine
|
Lamotrin Odt-25
|
25 mg
|
Oral Dispersible Tablet
|
Prescription Drug (RX)
|
Alu/Alu blister pack x 10's (Box of 30's)
|
-
|
Micro Labs Limited
|
India
|
|
Brown & Burk Phils., Inc.
|
Brown & Burk Phils., Inc.
|
-
|
12 March 2020
|
12 March 2025
|
| View |
|
DRP-8763
|
Paracetamol
|
Biogesic 325
|
325 mg
|
Tablet
|
Over-The-Counter (OTC)
|
Blister Foil x 10's (Box of 100's)
|
Analgesic / Antipyretic
|
Pt. Medifarma Laboratories
|
Indonesia
|
|
UNILAB, Inc.
|
|
Renewal
|
12 May 2024
|
13 March 2029
|
| View |
|
DRP-8764
|
Cetirizine Hydrochloride
|
Ceritec
|
1 mg/mL
|
Syrup
|
Over-The-Counter (OTC)
|
PET plastic bottle x 60mL (Box of 1's)
|
-
|
Y.S.P. Industries (M) Sdn. Bhd.
|
Malaysia
|
|
Yung Shin (Philippines), Inc.
|
|
-
|
31 March 2022
|
13 March 2025
|
| View |
|
DRP-8765-02
|
Clindamycin (as phosphate)
|
Clinamet
|
150 mg/mL (600 mg/4 mL)
|
Solution for Injection (I.M./I.V.)
|
Prescription Drug (Rx)
|
Borosilicate clear glass ampoule x 4 mL (net content) (Box of 5’s)
|
Antibacterial (Lincosamide)
|
CSPC Ouyi Pharmaceutical Co. Ltd
|
China
|
N/A
|
AMB HK Enterprises Inc.
|
Pro-jectable Pharmaceuticals, Inc.
|
CLIDP Conversion
|
09 December 2023
|
13 March 2025
|
| View |
|
DRP-8766
|
Levocetirizine Dihydrochloride
|
None
|
2.5mg/5mL
|
Syrup (Grapes Flavor)
|
Prescription Drug (Rx)
|
Boston Round Amber Bottle with Aluminum Cap x 30mL & 60mL (Box of 1's)
|
-
|
Lifesquare Laboratories Inc.
|
Philippines
|
|
|
|
-
|
12 March 2020
|
12 March 2025
|
| View |
|
DRP-8767
|
Levocetirizine Dihydrochloride
|
None
|
2.5mg/5mL
|
Syrup (Strawberry-Banana Flavor)
|
Prescription Drug (Rx)
|
Boston Round Amber Bottle with Aluminum Cap x 30mL & 60mL (Box of 1's)
|
-
|
Lifesquare Laboratories Inc.
|
Philippines
|
|
|
|
-
|
13 March 2020
|
13 March 2025
|
| View |
|
DRP-8767-01
|
Levocetirizine Dihydrochloride
|
Zercin
|
2.5 mg/5 mL
|
Syrup (Strawberry Flavor)
|
Prescription Drug (RX)
|
Boston Round Amber Bottle with Aluminum Cap x 30
mL & 60 mL (Box of l's)
|
-
|
Lifesquare Laboratories, Inc.
|
Philippines
|
|
|
Novomed Inc.
|
Initial
|
05 August 2021
|
13 March 2025
|
| View |
|
DRP-8767-02
|
Levocetirizine Dihydrochloride
|
Velozet
|
2.5 mg/5 mL
|
Syrup (Strawberry-Banana Flavor)
|
Prescription Drug (RX)
|
Boston Round Amber Bottle with Aluminum Cap x
30mL and 60mL (Box of l's)
|
-
|
LifeSquare Laboratories Inc.
|
Philippines
|
|
|
Korn C Philippines Inc.
|
-
|
12 November 2021
|
13 March 2025
|
| View |
|
DRP-8767-03
|
Levocetirizine Dihydrochloride
|
Trezin
|
2.5mg/5mL
|
Syrup (Strawberry-Banana Flavor)
|
Prescription Drug (RX)
|
Boston Round Amber Bottle with Aluminium Cap x 30 mL & 60 mL (Box of 1’s)
|
Antihistamine (Piperazine derivative)
|
Lifesquare Laboratories, Inc.
|
Philippines
|
N/A
|
N/A
|
Alman Pharmaceuticals, Inc.
|
Initial (CLIDP)
|
26 July 2022
|
13 March 2025
|
| View |
|
DRP-8768
|
Midazolam Hydrochloride
|
Sedacum
|
5 mg/mL
|
Solution For Injection (Im/Iv)
|
Prescription Drug (RX)
|
5mL USP Type I clear glass ampoule x 3mL (box of 5 ampoules)
|
ANXIOLYTIC
|
PT. Ferron Par Pharmaceuticals
|
Indonesia
|
|
Glorious Dexa Mandaya, Inc.
|
Glorious Dexa Mandaya, Inc.
|
Automatic Renewal
|
31 January 2023
|
13 June 2028
|
| View |
|
DRP-8769
|
Allopurinol
|
Allunol
|
300 mg
|
Tablet
|
Prescription Drug (RX)
|
Aluminum Foil Strip x 10's (Box of 100's)
|
-
|
Lloyd Laboratories, Inc.
|
Philippines
|
Westfield Pharmaceuticals, Inc.
|
|
|
-
|
12 October 2020
|
19 October 2025
|
| View |
|
DRP-8770
|
Gemcitabine (As Hydrochloride)
|
Gemosanz-200
|
200 mg
|
Powder For Solution For Iv Infusion
|
Prescription Drug (Rx)
|
USP Type I clear glass vial with slotted rubber plug and blue flip-off seal x 10mL (Box of 1's)
|
Antineoplastic (Cell Cycle-Specific Agent)
|
Admac Lifesciences
|
India
|
|
Ambica International Crop.
|
Ambica International Crop.
|
Automatic Renewal
|
13 October 2022
|
07 November 2028
|
| View |
|
DRP-8771
|
Gemcitabine (as Hydrochloride)
|
Gemosanz-1000
|
1 g
|
Powder for Solution for IV Infusion
|
Prescription Drug (Rx)
|
USP Type I Clear Glass Vial with Slotted Rubber Plug and Blue Flip-off Seal x 50 mL (Box of 1's)
|
Antineoplastic (Cell Cycle-Specific Agent)
|
Admac Lifesciences
|
India
|
Unicare Healthsciences Pvt. Ltd
|
Ambica International Corporation
|
Detoxicare Philippines, Inc
|
Renewal
|
03 November 2022
|
07 November 2028
|
| View |
|
DRP-8772
|
Azithromycin (As Dihydrate)
|
Azilide-250
|
250mg
|
Film Coated Tablet
|
Prescription Drug (RX)
|
Alu/Alu Blister Pack x 6's (Box of 6's)
Alu/Alu Blister Pack x 3's (Box of 30's)
|
Antibacterial (Macrolide)
|
Micro Labs Limited
|
India
|
|
Brown & Burk Phils., Inc.
|
Brown & Burk Phils., Inc.
|
Automatic Renewal
|
20 July 2023
|
19 December 2028
|
| View |
|
DRP-8773
|
Acetylcysteine
|
Exflem
|
600 mg
|
Effervescent Tablet
|
Prescription Drug (RX)
|
White Polypropylene Plastic Canister x 10's (Box of l's)
|
Mucolytic
|
Neutec Ilac San. Tic. A.S.
|
Turkey
|
|
UNILAB, Inc.
|
UNILAB, Inc.
|
Automatic Renewal
|
08 January 2021
|
21 March 2027
|
| View |
DRP-8776_PI_01.pdf
|
DRP-8776
|
Hydrocortisone Acetate + Benzocaine + Benzalkonium Chloride (1% Solution) + Bismuth Subgallate
|
Kortos Cream
|
5mg/ 25mg/ 100mg/ 20mg
|
Cream
|
Prescription Drug (RX)
|
30 g Laminated PE/Alu Tube with applicator
|
-
|
Exeltis Ilac San. Ve Tic. A.S.
|
Turkey
|
Embil International Philippines, Inc.
|
Interphil Laboratories, Inc.
|
N/A
|
-
|
15 April 2021
|
25 April 2026
|
| View |
|
DRP-8777
|
Bupivacaine Hydrochloride
|
Bupsan
|
5 mg/mL (0.5% w/v)
|
Solution for Intrathecal Injection
|
Prescription Drug (RX)
|
USP Type I clear glass ampoule x 5 mL & 10 mL (net content) Box of 5's and 1's
|
-
|
Kamla Lifesciences Limited
|
India
|
N/A
|
SRS Life Sciences Inc.
|
Endure Medical Inc.
|
Initial (Variation) (Reconstructed)
|
31 January 2023
|
28 December 2027
|
| View |
|
DRP-8778
|
Mefenamic Acid
|
Dolfenal
|
500 mg
|
Film-Coated Tablet
|
Prescription Drug (RX)
|
Aluminum foil strip x 4's (Box of 100's)
|
Anti-Inflammatory and Anti-Rheumatic Products, Non-Steroids (Fenamates)
|
Amherst Laboratories, Inc.
|
Philippines
|
United Laboratories, Inc.
|
|
|
Automatic Renewal
|
24 March 2022
|
25 May 2027
|