| View |
|
DRP-8914-02
|
Valsartan + Amlodipine (as besilate)
|
Valsadex-165
|
160 mg/5 mg
|
Film-Coated Tablet
|
Prescription Drug (RX)
|
Alu/Alu Blister Pack x 10's (Box of 30's)
|
Angiotensin II Receptor Blocker (ARB) / Calcium Channel Blocker (CCB)
|
Stallion Laboratories Pvt. Ltd.
|
India
|
|
Ambica International Corporation
|
Labmate Pharma Inc.
|
Renewal
|
25 July 2024
|
24 June 2030
|
| View |
|
DRP-8914-03
|
Valsartan + Amlodipine (as besilate)
|
Valrexpin
|
160 mg/5 mg
|
Film-Coated Tablet
|
Prescription Drug (Rx)
|
Alu/Alu Blister Pack x 10's (Box of 30's)
|
Angiotensin II Receptor Blocker (ARB)/ Calcium Channel Blocker (CCB)
|
Stallion Laboratories Pvt. Ltd.
|
India
|
N/A
|
Ambica International Corporation
|
Rexmed Pharmaceutical Sales
|
Renewal
|
06 August 2024
|
24 June 2030
|
| View |
|
DRP-8915
|
Etoricoxib
|
None
|
120 mg
|
Film-Coated Tablet
|
Prescription Drug (RX)
|
Alu-Alu Blister Pack x 10's (Box of 30's)
|
Anti-inflammatory and Antirheumatic Product, Non-steroid
|
Zim Laboratories Limited
|
India
|
|
I.E. Medica, Inc.
|
I.E. Medica, Inc.
|
Automatic Renewal
|
17 February 2023
|
22 June 2028
|
| View |
|
DRP-8916
|
Etoricoxib
|
Etrox
|
120 mg
|
Film-Coated Tablet
|
Prescription Drug (RX)
|
Alu-Alu Blister Pack x 10's (Box of 30's)
|
Anti-inflammatory and Antirheumatic Product, Non-Steroid
|
Zim Laboratories Limited
|
India
|
|
I.E. Medica, Inc.
|
I.E. Medica, Inc.
|
Automatic Renewal
|
17 February 2023
|
22 June 2028
|
| View |
|
DRP-8917
|
Etoricoxib
|
Nasaid
|
120mg
|
Film-Coated Tablet
|
Prescription Drug (RX)
|
Alu-Alu Blister Pack x 10's (Box of 30's)
|
-
|
Zim Laboratories Limited
|
India
|
|
I.E. Medica, Inc.
|
MedEthix, Inc.
|
-
|
22 June 2020
|
22 June 2025
|
| View |
|
DRP-8918
|
Multivitamins + Minerals + Amino Acids
|
Revivn
|
(See Reverse for formulation)
|
Capsule
|
Over-the-Counter (OTC)
|
Alu-Alu Strip Pack x 10's (Box of 30's and 100's)
|
-
|
Fredun Pharmaceuticals Limited
|
India
|
|
Phi1Rx Pharma Inc.
|
Phi1Rx Pharma Inc.
|
-
|
22 June 2020
|
22 June 2025
|
| View |
|
DRP-8919
|
Tobramycin + Dexamethasone
|
Tobaren
|
3 mg / 1 mg per Ml (0.3%/0.1% w/v)
|
Sterile Ophthalmic Suspension (Eye Drops)
|
Prescription Drug (RX)
|
LDPE Plastic Bottle with LDPE inner cap and HDPE outer cap x 5mL (Box of 1's)
|
-
|
Samchundang Pharm. Co., Ltd.
|
Korea
|
|
One Pharma Co.,Inc.
|
One Pharma Co.,Inc.
|
-
|
24 June 2020
|
24 June 2025
|
| View |
|
DRP-8920
|
Capecitabine
|
Bdocin 150
|
150 mg
|
Film-Coated Tablet
|
Prescription Drug (Rx)
|
Alu/PVC Blister Pack x 10's (Box of 60's)
|
-
|
BDR Pharmaceuticals International Pvt. Ltd. (Oncology Unit)
|
India
|
|
Ambica International Trading Corp.
|
Ambica International Trading Corp.
|
Initial (Compliance)
|
14 June 2022
|
24 June 2025
|
| View |
|
DRP-8921
|
Solifenacin Succinate
|
Vesifix
|
5mg
|
Film-Coated Tablet
|
Prescription Drug (Rx)
|
Alu/PVC/Aclar/PVDC/PVC Transparent clear blister pack x 10's (Box of 30's)
|
-
|
Nobel Ilac Sanayii Ve Ticaret A.S.
|
Turkey
|
|
Ambicare Pharmaceuticals, Inc.
|
Ambicare Pharmaceuticals, Inc.
|
-
|
10 December 2021
|
24 June 2025
|
| View |
|
DRP-8922
|
Solifenacin Succinate
|
Vesifix
|
10 mg
|
Film-Coated Tablet
|
Prescription Drug (RX)
|
Alu/PVC/Aclar/PVDC/PVC Transparent Clear Blister Pack x 10's (Box of 30's)
|
-
|
Nobel llac Sanayi Ve Ticaret A.S.
|
Turkey
|
N/A
|
Ambicare Pharmaceuticals Inc.
|
Genace Pharma Distributor
|
Initial (Variation)
|
28 June 2022
|
28 June 2027
|
| View |
|
DRP-8923
|
Metronidazole + Miconazole Nitrate
|
Metindaz Forte
|
750mg / 200mg
|
Vaginal Suppository
|
Prescription Drug (Rx)
|
PVC/PE Blister strip x 7 (Box of 7's)
|
-
|
Farmaprim Ltd.
|
Moldovo
|
|
Ambica International Trading Corp.
|
Ambica International Trading Corp.
|
-
|
24 June 2020
|
24 June 2025
|
| View |
|
DRP-8923-01
|
Metronidazole + Miconazole nitrate
|
Micronida Forte
|
750 mg/200 mg
|
Vaginal Suppository
|
Prescription Drug (Rx)
|
PVC/PE blister strip x 7 (Box of 7's)
|
Antiprotozoal/ Anti-infective/ Antifungal
|
Farmaprim Ltd
|
Republic of Moldova
|
N/A
|
Ambica International Corporation
|
Option One Enterprise
|
-
|
27 June 2022
|
24 June 2025
|
| View |
|
DRP-8923-02
|
Metronidazole + Miconazole nitrate
|
Inserdin
|
750 mg/200 mg
|
Vaginal Suppository
|
Prescription Drug (Rx)
|
PVC/PE Blister Strip x 7 (Box of 7’s)
|
Antiprotozoal/Anti-infective/Antifungal
|
Farmaprim S.R.L.
|
Moldova
|
N/A
|
Ambica International Corporation
|
Medchoice Women’s Health (MCWH), Inc
|
CLIDP Conversion
|
08 January 2024
|
24 June 2025
|
| View |
|
DRP-8924
|
Metronidazole + Miconazole Nitrate
|
Metindaz
|
500mg/100mg
|
Vaginal Suppository
|
Prescription Drug (Rx)
|
PVC/PE Blister strip x 7 (Box of 14's)
|
Antiprotozoal/ Anti-infective/ Antifungal
|
Farmaprim Ltd.
|
Moldovo
|
|
Ambica International Trading Corp.
|
Ambica International Trading Corp.
|
-
|
24 June 2020
|
24 June 2025
|
| View |
|
DRP-8924-01
|
Metronidazole + Miconazole nitrate
|
Metricored
|
500 mg/100 mg
|
Vaginal Suppository
|
Prescription Drug (Rx)
|
PVC/PE Blister Strip x 7 (Box of 14's)
|
-
|
Farmaprim S.R.L.
|
Republic of Moldova
|
N/A
|
Ambica International Corporation
|
Red Drug Pharmaceutical Inc.
|
CLIDP Conversion
|
24 October 2022
|
24 June 2025
|
| View |
|
DRP-8925
|
Zoledronic Acid
|
Zdonate
|
4mg/5mL
|
Concentrate Solution for IV Infusion
|
Prescription Drug (RX)
|
5 mL Clear Plastic (CZ-resin) Vial with bromobutyl
rubber stopper and aluminium flip-off seal (Box of l's)
|
-
|
Gland Pharma Limited
|
India
|
|
Biocare Lifesciences, Inc.
|
Biocare Lifesciences, Inc.
|
-
|
31 October 2020
|
31 October 2025
|
| View |
|
DRP-8926
|
Rifampicin + Isoniazid+Pyrazinamide + Ethambutol Hydrochloride
|
Ifamso PE
|
150mg/75mg/400mg/275 mg
|
Film Coated Tablet
|
Prescription Drug (RX)
|
Alu/PVC-PVDC Blister Pack x 28's
|
-
|
Svizera Labs Private Limited
|
India
|
|
Ambica International Corporation
|
Ambica International Corporation
|
-
|
03 December 2021
|
02 July 2025
|
| View |
|
DRP-8926-01
|
Rifampicin + Isoniazid + Pyrazinamide + Ethambutol Hydrochloride
|
Flamaway-4
|
150mg/75mg/400mg/275mg
|
Film-Coated Tablet
|
Prescription Drug (RX)
|
Alu/PVC-PVDC blister pack x 28's (Box of 672's)
|
-
|
Svizera Labs Private Limited
|
India
|
|
Ambica International Corporation
|
Ambicare Pharmaceuticals Inc.
|
-
|
15 September 2021
|
02 July 2025
|
| View |
|
DRP-8927
|
Rifampicin+ Isoniazid
|
Ifamso
|
150mg/75mg
|
Film Coated Tablet
|
Prescription Drug (RX)
|
Alu/PVC-PVDC Blister Pack x 28's
|
-
|
Svizera Labs Private Limited
|
India
|
|
Ambica International Corporation
|
Ambica International Corporation
|
-
|
03 December 2021
|
02 July 2025
|
| View |
|
DRP-8927-01
|
Rifampicin + Isoniazid
|
Flamaway-2
|
150 mg/75 mg
|
Film-Coated Tablet
|
Prescription Drug (RX)
|
Alu/PVC-PVDC blister pack x 28's (Box of 672's)
|
-
|
Svizera Labs Private Limited
|
India
|
|
Ambica International Corporation
|
Ambicare Pharmaceuticals Inc.
|
-
|
15 September 2021
|
02 July 2025
|