| View |
|
DRP-8698
|
Pemetrexed (as disodium Hemipetahydrate)
|
Prixanep-500
|
500mg
|
Lyophilized Powder For Intravenous Infusion
|
Prescription Drug (RX)
|
USP Type I Glass vial with grey bromo butyl stopper and an aluminum seal with grey cap (Box of 1's)
|
-
|
Shilpa Medicare Limited
|
India
|
|
Ambica International Crop.
|
Ambica International Crop.
|
-
|
05 February 2020
|
05 February 2025
|
| View |
|
DRP-8699
|
Oxaliplatin
|
Oxanish-50
|
2mg/Ml (50mg/25mL)
|
Solution for Injection (IV)
|
Prescription Drug (RX)
|
USP Type I Amber Glass Vial x 30ml (Box of 1's)
|
Antineoplastic
|
Admac Lifesciences
|
India
|
|
Pharmastar Int'l Trading Corp.
|
Pharmastar Int'l Trading Corp.
|
Automatic Renewal
|
05 April 2023
|
12 September 2028
|
| View |
|
DRP-8699-01
|
Oxaliplatin
|
Oxa-Health 50
|
2 mg/mL (50 mg/25 mL)
|
Solution For Injection
|
Prescription Drug (RX)
|
USP Type I Amber Glass Vial x 30 mL (Box of 1's)
|
Antineoplastic
|
Admac Lifesciences
|
India
|
|
Pharmastar Int'l Trading Corp.
|
Healthwinds Medical Trading Corp.
|
Automatic Renewal
|
28 June 2023
|
12 September 2028
|
| View |
|
DRP-8699-02
|
Oxaliplatin
|
Oxawind
|
2mg/mL (50mg/25mL)
|
Solution for Injection (IV)
|
Prescription Drug (Rx)
|
USP Type I Amber Glass Vial x 30mL (Box of 1's)
|
Antineoplastic
|
Admac Lifesciences
|
India
|
N/A
|
Pharmastar Int'l Trading Corp.
|
Healthwinds Medical Trading Corp.
|
Renewal
|
31 May 2023
|
12 September 2028
|
| View |
|
DRP-8700
|
Calcium + Cholecalciferol Vitamin D3
|
Dicarbo
|
158mg/400IU
|
Tablet
|
Over-The-Counter (OTC)
|
Alu/PVC Blister Pack x 10's (Box of 100's)
|
-
|
Kolmar Korea Co., Ltd.
|
Korea
|
|
H & B Pharma International Inc.
|
|
Initial (OTC) [PCPR] (Compliance) (Revalidation)
|
10 August 2021
|
06 February 2025
|
| View |
|
DRP-8701
|
Butorphanol Tartrate
|
Zinol
|
2mg/mL
|
Solution For Injection (I.M. And I.V.)
|
Prescription Drug (RX)
|
1mL USP Type 1 Amber Glass Ampoule (Box of 10's)
|
-
|
Hanlin Pharm. Co. Ltd.
|
Korea
|
|
Endure Medical, Inc.
|
Endure Medical, Inc.
|
-
|
01 April 2020
|
07 February 2025
|
| View |
DRP-8702_PI_01.pdf
|
DRP-8702
|
Azithromycin (As Dihydrate)
|
Zithromax
|
500mg
|
Film-Coated Tablet
|
Prescription Drug (RX)
|
White opaque PVC/Alu Blister Pack x 3's (Box of 3's)
|
-
|
Pfizer Pharmaceuticals LLC
|
United States of America
|
|
Pfizer, Inc.
|
|
Initial
|
07 February 2020
|
07 February 2025
|
| View |
|
DRP-8702-01
|
Azithromycin (As Dihydrate)
|
None
|
500mg
|
Film-Coated Tablet
|
Prescription Drug (RX)
|
White opaque PVC/Alu Blister pack x 3's (Box of 3's)
|
-
|
Pfizer Pharmaceutical LLC
|
United States of America
|
Pfizer Manufacturing Deutschland GmbH
|
Pfizer, Inc.
|
Philusa Corporation
|
CLIDP
|
07 April 2020
|
07 February 2025
|
| View |
DRP-8703_PI_01.pdf
|
DRP-8703
|
Azithromycin (As Dihydrate)
|
Zithromax
|
25 mg
|
Film-Coated Tablet
|
Prescription Drug (RX)
|
White opaque PVC/Alu Blister Pack x 3's (Box of 3's)
|
-
|
Pfizer Pharmaceuticals LLC
|
United States of America
|
|
Pfizer, Inc.
|
|
Initial
|
07 February 2020
|
07 February 2025
|
| View |
|
DRP-8704
|
Sevoflurane
|
Sevosha
|
250mL
|
Liquid For Inhalation
|
Prescription Drug (RX)
|
Type III Amber Glass Bottle
|
-
|
SHANGHAI HENGRUI PHARMACEUTICAL CO. LTD.
|
China
|
|
Nueva Sunshine Phils., Inc.
|
Nueva Sunshine Phils., Inc.
|
-
|
07 February 2020
|
07 February 2025
|
| View |
|
DRP-8704-01
|
Sevoflurane
|
Veeforane
|
100% Liquid for Inhalation
|
|
Prescription Drug (Rx)
|
USP Type III Amber Glass bottle x 250 mL (Box of 1's)
|
General Anesthetic
|
Shanghai Hengrui Pharmaceutical Co., Ltd.
|
China
|
N/A
|
Nueva Sunshine Phils., Inc.
|
Amson Pharmaceuticals
|
-
|
03 March 2022
|
07 February 2025
|
| View |
|
DRP-8705
|
Rosuvastatin (As Calcium)
|
Rosumax-20
|
20mg
|
Film-Coated Tablet
|
Prescription Drug (RX)
|
Alu-Alu Blister Pack x 10 (Box of 30's)
|
-
|
Gracure Pharmaceutical Ltd.
|
India
|
|
Dreamax Incorporated
|
Dreamax Incorporated
|
-
|
07 February 2020
|
07 February 2025
|
| View |
|
DRP-8705-01
|
Rosuvastatin (as calcium)
|
Govastatin
|
20mg
|
Film-Coated Tablet
|
Prescription Drug (Rx)
|
Alu/Alu Blister Pack x 10's (Box of 30's)
|
HMG CoA Reductase Inhibitor
|
Gracure Pharmaceutical Ltd.
|
India
|
N/A
|
Dreamax Incorporated
|
Applied Pharmaceutical Distribution Inc.
|
-
|
16 February 2022
|
07 February 2025
|
| View |
|
DRP-8705-02
|
Rosuvastatin (as calcium)
|
HypiMED-20
|
20 mg
|
Film-Coated Tablet
|
Prescription Drug (Rx)
|
Alu/Alu Blister Pack x 10's ( Box of 30's )
|
HMG CoA Reductase Inhibitor
|
Gracure Pharmaceutical Ltd.
|
India
|
N/A
|
Dreamax Incorporated
|
Thymed Enterprises
|
-
|
18 May 2022
|
07 February 2025
|
| View |
|
DRP-8706
|
Rosuvastatin (As Calcium)
|
Rosumax-10
|
10mg
|
Film-Coated Tablet
|
Prescription Drug (RX)
|
Alu-Alu Blister Pack x 10 (Box of 30's)
|
-
|
Gracure Pharmaceutical Ltd.
|
India
|
|
Dreamax Incorporated
|
Dreamax Incorporated
|
-
|
07 February 2020
|
07 February 2025
|
| View |
|
DRP-8706-01
|
Rosuvastatin (as calcium)
|
Govastatin
|
10 mg
|
Film-Coated Tablet
|
Prescription Drug (Rx)
|
Alu/Alu Blister Pack x 10's (Box of 30's)
|
HMG CoA Reductase Inhibitor
|
Gracure Pharmaceutical Ltd.
|
India
|
N/A
|
Dreamax Incorporated
|
Applied Pharmaceutical Distribution Inc.
|
-
|
16 February 2022
|
07 February 2025
|
| View |
|
DRP-8706-02
|
Rosuvastatin (as Calcium)
|
HypiMed-10
|
10 mg
|
Film-Coated Tablet
|
Prescription Drug (Rx)
|
Alu/Alu Blister Pack x 10's (Box of 30's)
|
HMG CoA Reductase Inhibitor
|
Gracure Pharmaceutical Ltd.
|
India
|
N/A
|
Dreamax Incorporated
|
Thymed Enterprises
|
-
|
20 May 2022
|
07 February 2025
|
| View |
|
DRP-8707
|
Pregabalin
|
Pregamax-75
|
75mg
|
Capsule
|
Prescription Drug (RX)
|
Alu-Alu Blister x 7 (Box of 14)
|
-
|
Gracure Pharmaceutical Ltd.
|
India
|
|
Dreamax Incorporated
|
Dreamax Incorporated
|
-
|
07 February 2020
|
07 February 2025
|
| View |
|
DRP-8707-01
|
Pregabalin
|
Prebaxine
|
75 mg
|
Capsule
|
Prescription Drug (Rx)
|
Alu/Alu Blister Pack x 10's (Box of 30's)
|
Antiepileptic
|
Gracure Pharmaceutical Ltd.
|
India
|
N/A
|
Dreamax Incorporated
|
Thymed Enterprises
|
CLIDP Conversion
|
29 July 2022
|
07 February 2025
|
| View |
|
DRP-8708
|
Esomeprazole
|
TGZol
|
40mg
|
Enteric-Coated Tablet
|
Prescription Drug (RX)
|
Alu-Alu Blister Pack x 10 (Box of 30's)
|
-
|
Gracure Pharmaceutical Ltd.
|
India
|
|
Dreamax Incorporated
|
Dreamax Incorporated
|
Automatic Renewal
|
16 February 2022
|
07 February 2025
|