| View |
|
DRP-971
|
Isoflurane
|
Isorane
|
100% V/V
|
Liquid Inhalation
|
Prescription Drug (RX)
|
Type III Amber Glass Bottle with black phenol screw
cap and polyethylene cone x 100 mL (Box of 1's)
|
-
|
Piramal Enterprises Limited
|
India
|
|
I.E. Medica, Inc.
|
L.E. Medica, Inc.
|
-
|
12 January 2021
|
07 July 2026
|
| View |
|
DRP-9710
|
Ibuprofen
|
Saphfen-400
|
400 mg
|
Tablet
|
Over-the-Counter (OTC)
|
Alu/Clear PVC Blister Pack x 10's (Box of 100's)
|
-
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
|
Nelpa Lifesciences, Inc.
|
|
-
|
11 May 2021
|
11 May 2026
|
| View |
|
DRP-9711
|
Phospholipids
|
Saphlive
|
300 mg
|
Capsule
|
Over-the-Counter (OTC)
|
Alu/Clear PVC Blister Pack x 10's (Box of 100's)
|
-
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
|
Nelpa Lifesciences, Inc.
|
|
-
|
11 May 2021
|
11 May 2026
|
| View |
|
DRP-9711-01
|
Multivitamins + Phospholipids
|
None
|
(See reverse for formulation)
|
Capsule
|
Over-the-Counter (OTC) Drug
|
Alu/Clear PVC Blister Pack x 10's / (Box of 100's)
|
Vitamins/Hepatoprotective
|
Sapphire Lifesciences Pvt. Ltd
|
India
|
|
Nelpa Lifesciences, Inc.
|
|
CLIDP Conversion
|
04 August 2024
|
01 June 2026
|
| View |
|
DRP-9712
|
Mefenamic Acid
|
Mefesaph -C250
|
250 mg
|
Capsule
|
Over-the-Counter (OTC)
|
Alu/Clear PVC Blister Pack x 10's (Box of 100's)
|
-
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
|
Nelpa Lifesciences, Inc.
|
|
-
|
11 May 2021
|
11 May 2026
|
| View |
|
DRP-9713
|
Phenylephrine HCl + Chlorphenamine Maleate
|
Saphendrine-2.5
|
2.5 mg/500 mcg per mL
|
Syrup (Oral Drops)
(Orange Flavor)
|
Over-the-Counter (OTC)
|
PET Round Amber Bottle Sealed with White HDPE Cap
x 15 mL and 30mL with Plastic Dropper (Box of 1's)
|
-
|
Azine Healthcare Pvt. Ltd.
|
India
|
|
Nelpa Lifesciences, Inc.
|
|
-
|
11 May 2021
|
11 May 2026
|
| View |
|
DRP-9714
|
Phenylephrine HCl + Brompheniramine Maleate
|
Saphtinamine-6.25
|
6.25 mg/2 mg per mL
|
Syrup (Oral Drops)
(Orange Flavor)
|
Over-the-Counter (OTC)
|
PET Round Amber Bottle Sealed with White HDPE Cap
x 15mL and 30mL with Plastic Dropper (Box of 1's)
|
-
|
Azine Healthcare Pvt. Ltd.
|
India
|
|
Nelpa Lifesciences, Inc.
|
|
-
|
11 May 2021
|
11 May 2026
|
| View |
|
DRP-9715
|
Butamirate Citrate
|
Saphmirate
|
7.5 mg/5 mL
|
Syrup (Caramel Flavor)
|
Over-the-Counter (OTC)
|
PET Round Amber Bottle Sealed with White HDPE Cap
x 60 mL and 120 mL (Box of 1's)
|
-
|
Azine Healthcare Pvt. Ltd.
|
India
|
|
Nelpa Lifesciences, Inc.
|
|
-
|
11 May 2021
|
11 May 2026
|
| View |
|
DRP-9716
|
Multivitamins + Lysine Hydrochloride + Buclizine Hydrochloride + Iron
|
Saphlizine - Fe
|
Formulation Each 5mL contains: Ascorbic Acid (Vitamin C) Retinol Palmitate (Vitamin A) Niacinamide (Vitamin B3) D-Panthenol (Vitamin B5) Thiamine HCl (Vitamin B1) Riboflavin (Vitamin B2)
100 mg 2,000 IU 18 mg 3 mg 1 mg 1 mg
Pyridoxine HCl (Vitamin B6) Cholecalciferol (Vitamin D3) Q-tocopheryl (Vitamin E) Cyanocobalamin (Vitamin B12) Lysine HCI Buclizine HCI Iron
1 mg 200 IU I IU 1 mcg 100 mg 5 mg 15 mg (equivalent to 75 mg Ferrous Sulfate Heptahydrate)
|
Syrup (Raspberry Flavor)
|
Over-the-Counter (OTC)
|
60 mL and 120 mL PET Round Amber Bottle with White HDPE Cap
|
Vitamins/Amino Acid/Appetite Stimulant/Mineral
|
Enicar Pharmaceuticals Pvt. Ltd.
|
India
|
|
Nelpa Lifesciences, Inc.
|
|
Initial
|
11 May 2021
|
11 May 2026
|
| View |
|
DRP-9717
|
Ascorbic Acid + Zinc
|
Saphceevit-45
|
5 mg (equivalent to 50.61 mg Sodium Ascorbate)/
4.5 mg (equivalent to 28.60 mg Zinc Ascorbate) per mL
|
Syrup (Oral Drops) (Orange Flavor)
|
Over-the-Counter (OTC)
|
PET Round Amber Bottle with White HDPE Cap X
15 mL and 30 mL with Plastic Dropper (Box of 1's)
|
-
|
Enicar Pharmaceuticals Pvt. Ltd.
|
India
|
|
Nelpa Lifesciences, Inc.
|
|
-
|
11 May 2021
|
11 May 2026
|
| View |
|
DRP-9718
|
Cetirizine Hydrochloride
|
Cetrisaph - 5
|
5 mg/ 5mL
|
Syrup (Orange Flavor)
|
Over-the-Counter (OTC)
|
PET Round Amber Bottle with White HDPE Capx
60 mL and 120 mL (Box of 1's)
|
-
|
Enicar Pharmaceuticals Pvt. Ltd.
|
India
|
|
Nelpa Lifesciences, Inc.
|
|
-
|
11 May 2021
|
11 May 2026
|
| View |
|
DRP-9718-01
|
Cetirizine hydrochloride
|
CETIRED-5MG
|
5 mg/5 mL
|
Syrup (Orange Flavor)
|
Over-the-Counter (OTC) Drug
|
PET Round Amber Bottle with White HDPE Cap x 60 mL and 120 mL (Box of 1’s)
|
Antihistamine
|
Enicar Pharmaceuticals Pvt. Ltd
|
India
|
N/A
|
Nelpa Lifesciences, Inc
|
777 Red Pharma Inc
|
CLIDP Conversion
|
09 January 2024
|
11 May 2026
|
| View |
|
DRP-9719
|
Phenylephrine Hydrochloride + Chlorphenamine Maleate
|
Saphlerine-2.5
|
2.5 mg/500 mcg per mL
|
Syrup (Oral Drops)
(Orange Flavor)
|
Over-the-Counter (OTC)
|
PET Round Amber Bottle with White HDPE Cap x
15 mL and 30 mL with Plastic Dropper (Box of l's)
|
-
|
Enicar Pharmaceuticals Pvt. Ltd.
|
India
|
|
Nelpa Lifesciences, Inc.
|
|
-
|
11 May 2021
|
11 May 2026
|
| View |
|
DRP-972
|
Gentamicin (As Sulfate)
|
Genom
|
40mg/mL
|
Solution For Injection
|
Prescription Drug (RX)
|
Clear Glass Ampoule x 2mL (Box of 1 blister pack x 10's)
|
Antibacterial (Aminoglycoside)
|
Geofman Pharmaceuticals
|
Pakistan
|
|
Sahar International Trading, Inc.
|
Sahar International Trading, Inc.
|
Automatic Renewal
|
13 July 2022
|
30 October 2027
|
| View |
|
DRP-9720
|
Ascorbic Acid
|
MAX-CEE
|
500mg (equivalent to 562.5mg Sodium Ascorbate)
|
Capsule
|
Over-the-Counter (OTC)
|
Alu/PVC Blister pack x 10's (Box of 100's)
|
VITAMIN
|
Mason Pharma
|
India
|
|
Finstad Inc.
|
|
Renewal
|
17 May 2024
|
11 May 2029
|
| View |
|
DRP-9721
|
Ascorbic Acid + Zinc
|
United Home Ceetab + Z
|
500mg (equivalent to 562.43mg Sodium Ascorbate /
10mg (equivalent to 27.50mg Zinc Sulfate Monohydrate)
|
Capsule
|
Over-The-Counter (OTC)
|
Alu/PVC Blister Pack x 10's (Box of 100's)
|
Vitamin / Mineral
|
AM-Europharma Corporation
|
Philippines
|
Unilab, Inc.
|
|
|
Initial [OTC][Correction]
|
06 July 2021
|
12 May 2026
|
| View |
|
DRP-9722
|
AMREI-C PLUS
|
Ascorbic Acid + Zinc
|
500mg (equivalent to 562.42mg Sodium Ascorbate) / 10mg (equivalent to 27.5mg Zinc Sulfate Monohydrate)
|
Capsule
|
Over-the-Counter (OTC) Drug
|
Alu/PVC Blister Pack x 10's (Box of 100's)
|
-
|
AM-Europharma Corporation
|
Philippines
|
Amreivax Corporation
|
N/A
|
N/A
|
-
|
12 May 2021
|
12 May 2026
|
| View |
|
DRP-9723
|
Allervocin
|
Levocetirizine Dihydrochloride
|
2.5 mg 5mL
|
Syrup
|
Prescription Drug (RX)
|
PET amber coloured bottle x 100 mL with 10 mL measuring cup (Box of 1's)
|
-
|
Medley Pharmaceuticals Limited
|
India
|
N/A
|
Ambica International Corporation
|
Ambica International Corporation
|
-
|
12 May 2021
|
12 May 2026
|
| View |
|
DRP-9724
|
Melivitron
|
Iron + Multivitamins
|
Formulation: Each capsule contains: Iron (equivalent to 200 mg ferrous fumarate)-70mg Cyanocobalamin (Vit. B12)-25mcg Thiamine Mononitrate (Vit. B1)-25mg Pyridoxine HCI (Vit. B6)-2.5mg
Riboflavin (Vit. B2)-2.5mg D-Calcium Panthothenate-12.5mg Nicotinamide (Vit. B3)-62.50mg Ascorbic Acid (Vit. C)-75mg
|
Capsule
|
Over-the-Counter (OTC) Drug
|
Alu/PVC Blister Pack x 10's (Box of 100's)
|
Vitamin/Mineral
|
Lejal Laboratories Inc.
|
Philippines
|
N/A
|
N/A
|
N/A
|
Renewal
|
01 June 2022
|
18 July 2027
|
| View |
|
DRP-9724-01
|
Iron + Multivitamins
|
Ferix BC
|
(see reverse formulation)
|
Capsule
|
Over-the-Counter (OTC) Drug
|
Alu/PVC Blister Pack x 10's (Box of 100's)
|
Vitamin/Mineral
|
Lejal Laboratories Inc.
|
Philippines
|
N/A
|
N/A
|
Bewell Nutraceuticals, Corp
|
Renewal
|
20 June 2022
|
18 July 2027
|