| View |
|
DR-XY44218
|
Levofloxacin (as Hemihydrate)
|
Levoxac
|
500mg
|
Film Coated tablet
|
Prescription Drug (RX)
|
Alu/Clear PVC Blister Pack x 10's (Box of 20's)
|
Antibacterial (Fluoroquinolone)
|
The IBN Sina Pharmaceutical Industry Ltd.
|
Bangladesh
|
|
Endure Medical, Inc.
|
Endure Medical, Inc.
|
Renewal
|
18 August 2024
|
26 February 2030
|
| View |
|
DR-XY44219
|
Oxytocin
|
None
|
10 IU/mL
|
Solution for Injection (IM/IV)
|
Prescription Drug (RX)
|
USO Type I clear glass ampoule x 1mL (box of 10's)
|
-
|
maanshan BBCA pharmaceutical co., ltd.
|
china
|
|
endure medical, inc.
|
endure medical, inc.
|
-
|
26 December 2019
|
26 February 2025
|
| View |
|
DR-XY44223
|
Salbutamol (As Sulfate)
|
None
|
200 mcg
|
Pre-Metered Dose Dry Powder For Inhalation
|
Prescription Drug (RX)
|
1 carton containing 1 box of 5 alu/alu blister pack x 8's + 1 inhaler device in a box
|
-
|
Lloyd Laboratores, Inc.
|
Philippines
|
|
|
|
-
|
21 February 2020
|
24 February 2025
|
| View |
|
DR-XY44225
|
Clonidine Hydrochloride
|
Clonin
|
75 mcg
|
Tablet
|
Prescription Drug (RX)
|
Alu/PVDC Blister Pack x 10's (Box of 30's)
|
-
|
Lloyd Laboratories, Inc.
|
Philippines
|
Vitalink Health Products, Inc.
|
|
|
-
|
11 February 2020
|
23 February 2025
|
| View |
|
DR-XY44226
|
Clonidine Hydrochloride
|
NORMIPRESS
|
150 mcg
|
Tablet
|
Prescription Drug (RX)
|
Alu/Clear PVDC Blister Pack x 10's (Box of 30's)
|
-
|
Lloyd Laboratories, Inc.
|
Philippines
|
Littman Drug Corporation
|
|
|
-
|
21 February 2020
|
23 February 2025
|
| View |
|
DR-XY44227
|
Clonidine Hydrochloride
|
Clopres
|
75 mcg
|
Tablet
|
Prescription Drug (RX)
|
Alu/Clear PVDC Blister pack x 10’s (Box of 30’s)
|
-
|
Lloyd Laboratories, Inc.
|
Philippines
|
Westfield Pharmaceuticals, Inc.
|
|
|
-
|
20 August 2020
|
23 February 2025
|
| View |
|
DR-XY44229
|
Atorvastatin (As Calcium)
|
None
|
10 mg
|
Film-Coated Tablet
|
Prescription Drug (RX)
|
Alu/Alu Blister Pack x 10's (Box of 30's)
|
-
|
Lloyd Laboratories, Inc.
|
Philippines
|
Ultramed Pharma Inc.
|
|
|
-
|
21 February 2020
|
27 February 2025
|
| View |
|
DR-XY44233
|
Valsartan
|
None
|
160 mg
|
Tablet
|
Prescription Drug (RX)
|
Aluminum Foil Strip x 8s (Box of 32's)
|
-
|
Amherst Laboratories, Inc.
|
Philippines
|
UNILAB, Inc.
|
|
|
-
|
19 February 2020
|
24 February 2025
|
| View |
|
DR-XY44234
|
Valsartan
|
None
|
80 mg
|
Tablet
|
Prescription Drug (RX)
|
Aluminum Strip Foil x 10s (Box of 30's)
|
-
|
Amherst Laboratories Inc.
|
Philippines
|
Unilab, Inc.
|
|
|
-
|
19 February 2020
|
24 February 2025
|
| View |
|
DR-XY44235
|
Simvastatin
|
Corvastin
|
80 mg
|
Film Coated tablet
|
Prescription Drug (RX)
|
Aluminum Strip Foil x 10's (Box of 30's)
|
-
|
Aurochem Laboratories
|
India
|
|
Endure Medical, Inc.
|
Endure Medical, Inc.
|
-
|
26 December 2019
|
24 February 2025
|
| View |
|
DR-XY44237
|
Levocitirizine Dihydrochloride
|
Levocit
|
5 mg
|
Film Coated Tablet
|
Prescription Drug (RX)
|
Alu/PVC Blister Pack x 10's (Box of 10's and 100's)
|
-
|
Brookes Pharma (Private) Limited
|
Pakistan
|
|
Sahar International Trading, Inc.
|
Sahar International Trading, Inc.
|
-
|
26 October 2020
|
25 February 2025
|
| View |
|
DR-XY44238
|
Acarbose
|
None
|
50 mg
|
Tablet
|
Prescription Drug (RX)
|
Alu/Alu Blister Pack x 10's (Box of 100's)
|
-
|
Northfield Laboratories, Inc.
|
Philippines
|
D.B. MANIX INTERNATIONAL, INC.
|
|
TGP PHARMA INC.
|
-
|
11 February 2020
|
24 February 2025
|
| View |
DR-XY44239_PI_01.pdf
|
DR-XY44239
|
Fluphenazine Decanoate
|
Fludexin
|
25mg/mL
|
Solution For Im Injection
|
Prescription Drug (RX)
|
1 mL Type 1 amber glass ampoule (Box of 5's)
|
-
|
Pharmafabrikon
|
India
|
|
Belkam Philippines, Inc.
|
Belkam Philippines, Inc.
|
-
|
18 June 2020
|
26 February 2025
|
| View |
|
DR-XY44240
|
Citicoline (As Sodium)
|
Zynazine 1000
|
250mg/mL (1g/4mL)
|
Solution For Iv/Im Injection
|
Prescription Drug (RX)
|
4 mL Type 1 clear and colorless glass ampoule (Box of
5's)
|
-
|
Furen Pharmaceutical Group Co., Ltd.
|
China
|
|
Belkam Philippines, Inc.
|
Belkam Philippines, Inc.
|
-
|
23 October 2020
|
26 February 2025
|
| View |
|
DR-XY44243
|
Lornoxicam
|
Zornica -8
|
8 mg
|
Film-Coated Tablet
|
Prescription Drug (RX)
|
Alu/PVC Blister Pack x 10's (Box of 30's)
|
Non-Steroidal Anti-Inflammatory Drug (NSAID)
|
Micro Labs Limited
|
India
|
|
Brown & Burk Phils., Inc.
|
Brown & Burk Phils., Inc.
|
Initial (from Monitored Release)
|
21 July 2022
|
24 February 2025
|
| View |
|
DR-XY44245
|
Triptorelin (As Embonate)
|
Pamorelin
|
22.5 mg
|
Lyophilized Powder for Injection (I.M.)
|
Prescription Drug (Rx)
|
USP/EP Type I glass vial with grey bromobutyl
rubber stopper and aluminum overseal with dark green colored plastic flip-off cover (Box of 1's)
|
Antineoplastic/Gonadotropin-Releasing Hormone Analogue
|
Debiopharm Research & Manufacturing S.A.
|
Switzerland
|
Bio-ONCO, Inc.
|
UNILAB, Inc.
|
UNILAB, Inc.
|
Initial (from Monitored Release) (correction)
|
30 January 2023
|
27 February 2025
|
| View |
|
DR-XY44246
|
Triptorelin (As Embonate)
|
Pamorelin
|
3.75 mg
|
Lyophilized Powder For Injection (IM/SC)
|
Prescription Drug (RX)
|
USP/EP Type I glass vial with grey bromobutyl rubber stopper and aluminum overseal with purple colored plastic flip-off cover (Box of 1's)
|
Antineoplastic/ Gonadotropin- Releasing Hormone Analogue
|
Debiopharm Research & Manufacturing S.A.
|
Switzerland
|
Bio-ONCO, Inc.
|
UNILAB, Inc.
|
UNILAB, Inc.
|
Initial (from Monitored Release)
|
19 April 2022
|
27 February 2025
|
| View |
|
DR-XY44247
|
Triptorelin (As Embonate)
|
Pamorelin
|
11.25 mg
|
Lyophilized Powder for Injection (I.M.)
|
Prescription Drug (Rx)
|
USP/EP Type I glass vial with grey bromobutyl stopper and aluminum overseal with yellow green colored plastic flip-off cover (Box of 1's)
|
Antineoplastic/Gonadotropin-Releasing Hormone Analogue
|
Debiopharm Research & Manufacturing S.A.
|
Switzerland
|
Bio-ONCO, Inc.
|
UNILAB, Inc.
|
UNILAB, Inc.
|
Initial (from Monitored Release) (correction)
|
30 January 2023
|
27 February 2025
|
| View |
|
DR-XY44248
|
Docetaxel
|
Bagotax
|
20 mg/0.5 mL
|
Concentrate Solution for lIntravenous Infusion
|
Prescription Drug (RX)
|
USP Type I transparent glass vial in 0.5 mL (net content as active) + USP Type I transparent glass vial in 1.83 mL (net content as diluent) (box of 1's)
|
-
|
Bioprofarma Bago S.A
|
Argentina
|
|
Apolliplus Capital Inc.
|
Apolliplus Capital Inc.
|
-
|
16 September 2019
|
27 February 2025
|
| View |
|
DR-XY44249
|
Docetaxel
|
Bagotax
|
40mg/mL (80mg/2mL)
|
Concentrate Solution for lIntravenous Infusion
|
Prescription Drug (RX)
|
USP Type I transparent glass vial in 2mL (Net content as active) + USP Type I transparent glass vial in 7.32mL (net content as diluent) (box of 1's)
|
-
|
Bioprofarma Bago S.A
|
Argentina
|
|
Apolliplus Capital Inc.
|
Apolliplus Capital Inc.
|
-
|
16 September 2019
|
27 February 2025
|