| View |
|
DRP-8571
|
Ascorbic Acid
|
Corcebic-C
|
500mg
|
Tablet
|
Over-the-Counter (OTC) Drug
|
Blister Foil Strp x 10's (Box of 100's)
|
-
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
|
Nelpa Lifesciences, Inc,
|
Nelpa Lifesciences, Inc,
|
-
|
05 February 2021
|
08 July 2026
|
| View |
|
DRP-8572
|
Gliclazide
|
None
|
80 mg
|
Modified- Release Tablet
|
Prescription Drug (RX)
|
Alu/Clear PVDC Blister Pack x 10's (Box of 30's)
|
-
|
Lloyd Laboratories, Inc.
|
Philippines
|
Vitalink Health Products Inc.
|
|
|
-
|
04 August 2020
|
16 June 2025
|
| View |
|
DRP-8573
|
Paracetamol + Orphenadrine Citrate
|
Paradrin
|
450 mg / 35 mg
|
Tablet
|
Prescription Drug (RX)
|
Alu/PVC Blister Pack x 10's (Box of 100's)
|
Analgesic/Antipyretic/Muscle Relaxant
|
Tabros Pharma (Pvt.) Ltd.
|
Pakistan
|
N/A
|
EuroAsia Pharmaceuticals, Inc.
|
EuroAsia Pharmaceuticals, Inc.
|
Automatic Renewal
|
03 June 2021
|
28 November 2026
|
| View |
|
DRP-8574
|
Paracetamol + Orphenadrine Citrate
|
Paradrin Forte
|
650 mg / 50 mg
|
Tablet
|
Prescription Drug (RX)
|
Alu/PVC Blister Pack x 10's (Box of 30's)
|
-
|
Tabros Pharma (Pvt.) Ltd.
|
Pakistan
|
N/A
|
EuroAsia Pharmaceuticals, Inc.
|
EuroAsia Pharmaceuticals, Inc.
|
Automatic Renewal
|
03 June 2021
|
28 November 2026
|
| View |
|
DRP-8575
|
Moxifloxacin (as hydrochloride)
|
None
|
400 mg
|
Film-Coated Tablet
|
Prescription Drug (RX)
|
Alu/Alu Blister Pack x 10's (Box of 20's)
|
-
|
XL Laboratories Pvt. Ltd.
|
India
|
N/A
|
Ambica International Corporation
|
International Pharmaceuticals, Inc
|
-
|
24 May 2021
|
25 May 2026
|
| View |
|
DRP-8575-01
|
Moxifloxacin (as hydrochloride)
|
Moxiflovic
|
400 mg
|
Film-Coated Tablet
|
Prescription Drug (RX)
|
Alu/Alu Blister Pack x 10's (Box of 20's)
|
-
|
XL Laboratories Pvt. Ltd.
|
India
|
N/A
|
Ambica International Corporation
|
Guimhealth Pharmaceutical Distributor and Drugstore
|
-
|
26 May 2021
|
25 May 2026
|
| View |
|
DRP-8576
|
Hydroquinone
|
None
|
40mg/g (4% w/w)
|
Topical Cream
|
Over-The-Counter (OTC)
|
PP Plastic Jar and PP cover w/LDPE liner x 15g
|
Other Dermatologicals
|
Stalder Laboratories, Inc.
|
Philippines
|
BCP Dermatological Corporation
|
|
|
Automatic Renewal
|
16 March 2022
|
25 May 2027
|
| View |
|
DRP-8577
|
Budesonide
|
Budesma
|
200 mcg
|
Metered Dose Inhalation
|
Prescription Drug (RX)
|
Aluminum canister filled with metering valve x 300 metered doses
|
Corticosteroid
|
Glenmark Pharmaceuticals Ltd.
|
India
|
|
Glenmark Philippines, Inc.
|
Glenmark Philippines, Inc.
|
Automatic Renewal
|
02 July 2023
|
27 December 2028
|
| View |
|
DRP-8578
|
Ascorbic Acid
|
Immutab
|
1g
|
Tablet
|
Over-The-Counter (OTC)
|
Alu/PVC Blister Pack x 10's
|
-
|
Kanion Pharmaceutical Co. Ltd.
|
China
|
|
AMB HK Enterprises Inc.
|
AMB HK Enterprises Inc.
|
Initial (correction)
|
18 December 2020
|
12 December 2024
|
| View |
|
DRP-8579
|
Ascorbic Acid
|
Immutab
|
500mg
|
Tablet
|
Over-The-Counter (OTC)
|
Alu/PVC Blister Pack x 10's
|
-
|
Kanion Pharmaceutical Co. Ltd.
|
China
|
|
AMB HK Enterprises Inc.
|
AMB HK Enterprises Inc.
|
Initial (correction)
|
18 December 2020
|
12 December 2024
|
| View |
|
DRP-858
|
Cefazolin (as sodium)
|
Leklin
|
1 g
|
Powder For Injection (I.M./ I.V.0
|
Prescription Drug (RX)
|
USP Type I Clear and Colourless Glass Vial with Rubber Stopper and Blue Flip-off Seal (Box of 1's)
|
Antibacterial (Cephalosporin)
|
Unique Pharmaceuticals Labs.
|
India
|
|
Ambica International Corporation
|
Ambica International Corporation
|
Automatic Renewal
|
11 February 2023
|
07 April 2028
|
| View |
|
DRP-8580
|
Docetaxel
|
Novataxel-80
|
40mg/Ml (80mg/2mL)
|
Concentrate Solution for IV Infusion
|
Prescription Drug (RX)
|
15mL-capacity USP Type I Clear glass Vial sealed with 20mm omniflex rubber stopper and non-tear-off aluminum seal with red polypropylene flip-off cap x 0.5mL (Box of 1's)
|
-
|
Venus Remedies Limited
|
India
|
|
Medinova Pharmaceutical Inc.
|
Medinova Pharmaceutical Inc.
|
-
|
18 December 2019
|
18 December 2024
|
| View |
|
DRP-8580-01
|
Docetaxel
|
Docegen-80
|
40mg/Ml (80mg/2mL)
|
Concentrate Solution for IV Infusion
|
Prescription Drug (RX)
|
15mL-Capacity USP Type I clear glass vial sealed with 20mm omniflex rubber stopper and non-tear-off aluminum seal with red polypropylene flip-off cap x 2mL (Box of 1's)
|
-
|
Venus Remedies Limited
|
India
|
|
Medinova Pharmaceutical Inc.
|
GA2 Pharmaceutical Inc.
|
-
|
09 July 2020
|
18 December 2024
|
| View |
|
DRP-8580-02
|
Docetaxel
|
Taxogen
|
40 mg/mL (80 mg/2 mL)
|
Concentrate Solution for IV
Infusion
|
Prescription Drug (RX)
|
15 mL-capacity USP Type I Clear Glass Vial sealed with
20 mm Omniflex Rubber Stopper and non-tear-off Aluminum Seal with Red Polypropylene Flip-off Cap x 2
mL (Box of l’s)
|
-
|
Venus Remedies, Limited
|
India
|
|
Medinova Pharmaceutical Inc.
|
Genace Pharma Distributor
|
-
|
24 November 2021
|
18 December 2024
|
| View |
|
DRP-8580-03
|
Docetaxel
|
Doxagen 80
|
|
40mg/mL (80mg/2mL)
|
Concentrate Solution for IV Infusion
|
15 mL-capacity USP Type I clear glass vial sealed with 20mm omniflex rubber stopper and non-tear off aluminum seal with red polypropylene flip-off cap x 2 mL (Box of 1's)
|
Antineoplastic
|
Venus Remedies, Limited
|
India
|
|
Medinova Pharmaceutical Inc.
|
GA2 Pharmaceutical Inc.
|
CLIDP Conversion
|
03 July 2023
|
18 December 2024
|
| View |
|
DRP-8580-04
|
Docetaxel
|
Docegard 80
|
40 mg / mL (80 mg / 2 mL)
|
Concentrate Solution for IV Infusion
|
Prescription Drug (Rx)
|
15 mL -capacity USP Type I clear glass vial sealed with 20 mm omniflex rubber stopper and non-tear-off aluminum seal with red polypropylene flip-off cap x 2 mL / (Box of 1's)
|
Antineoplastic
|
Venus Remedies, Limited
|
India
|
|
Medinova Pharmaceutical Inc
|
GA2 Pharmaceutical Inc
|
CLIDP Conversion
|
28 March 2024
|
18 December 2024
|
| View |
|
DRP-8581
|
Docetaxel
|
Novataxel-20
|
40mg/Ml (20mg/0.5mL)
|
Concentrate Solution for IV Infusion
|
Prescription Drug (RX)
|
15mL-capacity USP Type I Clear glass Vial sealed with 20mm omniflex rubber stopper and non-tear-off aluminum seal with red polypropylene flip-off cap x 0.5mL (Box of 1's)
|
-
|
Venus Remedies Limited
|
India
|
|
Medinova Pharmaceutical Inc.
|
Medinova Pharmaceutical Inc.
|
-
|
18 December 2019
|
18 December 2024
|
| View |
|
DRP-8581-01
|
Docetaxel
|
Docegen-20
|
40mg/Ml (20mg/0.5mL)
|
Concentrate Solution for IV Infusion
|
Prescription Drug (RX)
|
5 mL-capacity USP Type I Clear Glass Vial Sealed
with 20 mm Omniflex Rubber Stopper and Non-Tear off Aluminum Seal with Red Polypropylene Flip-Off Cap x 0.5 mL (Box of 1's)
|
-
|
Venus Remedies Limited
|
India
|
Prime Pharmaceuticals Pvt. Ltd.
|
Medinova Pharmaceutical Inc.
|
GA2 Pharmaceutical Inc.
|
-
|
08 October 2021
|
18 December 2024
|
| View |
|
DRP-8581-02
|
Docetaxel
|
Taxogen
|
40 mg/mL (20 mg/0.5 mL)
|
Concentrate Solution for IV
Infusion
|
Prescription Drug (RX)
|
5 mL-capacity USP Type I Clear Glass Vial sealed with
20 mm Omniflex Rubber Stopper and Non-Tear-Off Aluminum Seal with Red Polypropylene Flip-Off Cap x
0.5 mL (Box of 1's)
|
Antineoplastic
|
Venus Remedies, Limited
|
India
|
|
Medinova Pharmaceutical Inc.
|
Genace Pharma Distributor
|
CLIDP
|
24 November 2021
|
18 December 2024
|
| View |
|
DRP-8581-03
|
Docetaxel
|
Doxagen 20
|
40mg/mL (20mg/0.5mL)
|
Concentrate Solution for IV Infusion
|
Prescription Drug (Rx)
|
5 mL-capacity USP Type 1 clear glass vial sealed with 20mm omniflex rubber stopper and non-tear off aluminum seal with red polypropylene flip-off cap x 0.5 mL (Box of 1's)
|
Antineoplastic
|
Venus Remedies, Limited
|
India
|
|
Medinova Pharmaceutical Inc
|
GA2 Pharmaceutical Inc
|
CLIDP Conversion
|
30 June 2023
|
18 December 2024
|