| View |
|
DRP-9605
|
Ascorbic Acid
|
None
|
500 mg (equivalent to 605.20 mg Calcium Ascorbate)
|
Capsule
|
Over-The-Counter (OTC)
|
Alu-PVC/PVDC Amber Color Blister Pack x 10's (Box of 100's)
|
Vitamin
|
Lloyd Laboratories, Inc.
|
Philippines
|
Dr. Zen's Research, Inc.
|
|
|
Initial (OTC)
|
19 March 2021
|
19 March 2026
|
| View |
|
DRP-9607
|
Carbocisteine
|
Saphcisin-200
|
200mg/5mL
|
Syrup
|
Over-the-Counter (OTC)
|
PET Round Amber Bottle with White HDPE Cap x 60 mL and 120 mL (Box of 1's)
|
Mucolytic
|
Enicar Pharmaceuticals Pvt. Ltd.
|
India
|
Sapphire Lifesciences Pvt. Ltd.
|
Nelpa Lifesciences, Inc.
|
|
Initial (OTC)
|
24 March 2021
|
24 March 2026
|
| View |
|
DRP-9607-01
|
Carbocisteine
|
Tussis-200
|
200 mg/5 mL
|
Syrup
|
Over-the-Counter Drug (OTC)
|
PET Round Amber Bottle with White HDPE Cap x 60 mL and 120 mL (Box of 1's)
|
Mucolytic
|
Enicar Pharmaceuticals Pvt. Ltd
|
India
|
N/A
|
Nelpa Lifesciences, Inc.
|
Kaufmann Pharma Inc.
|
CLIDP Conversion
|
19 January 2023
|
24 March 2026
|
| View |
|
DRP-9608
|
Carbocisteine
|
Saphcisin-125
|
125mg/5mL
|
Syrup
|
Over-the-Counter (OTC)
|
PET Round Amber Bottle with White HDPE Cap x 60 mL and 120 mL with Plastic Dropper (Box of 1's)
|
Mucolytic
|
Enicar Pharmaceuticals Pvt. Ltd.
|
India
|
Sapphire Lifesciences Pvt. Ltd.
|
Nelpa Lifesciences, Inc.
|
|
Initial (OTC)
|
24 March 2021
|
24 March 2026
|
| View |
|
DRP-9608-01
|
Carbocisteine
|
Tussis-125
|
125 mg/5 mL
|
Syrup
|
Over-the-Counter (OTC) Drug
|
PET Round Amber Bottle with White HDPE Cap x 60 mL and 120 mL with Plastic Dropper (Box of 1's)
|
-
|
Enicar Pharmaceuticals Pvt. Ltd.
|
India
|
N/A
|
Nelpa Lifesciences, Inc.
|
Kaufmann Pharma Inc
|
CLIDP Conversion
|
24 January 2023
|
24 March 2026
|
| View |
|
DRP-9609
|
Carbocisteine
|
Saphcisin-100
|
100mg/5mL
|
Syrup
|
Over-the-Counter (OTC)
|
Additional Pack Size:
PET Round Amber Bottle with
White HDPE Cap x 10 mL (Physician's Sample) (Box of 1's)
|
Mucolytic
|
Enicar Pharmaceuticals Pvt. Ltd.
|
India
|
Sapphire Lifesciences Pvt. Ltd.
|
Nelpa Lifesciences, Inc.
|
|
Initial (OTC)
|
24 March 2021
|
24 March 2026
|
| View |
|
DRP-9609-01
|
Carbocisteine
|
Tussis-100
|
100 mg/5 mL
|
Syrup
|
Over-the-Counter (OTC) Drug
|
PET Round Amber Bottle with White HDPE Cap x 60 mL and 120 mL (Box of 1's)
|
-
|
Enicar Pharmaceuticals Pvt. Ltd.
|
India
|
N/A
|
Nelpa Lifesciences, Inc.
|
Kaufmann Pharma Inc
|
CLIDP Conversion
|
27 January 2023
|
24 March 2026
|
| View |
|
DRP-9609-02
|
Carbocisteine
|
Carbocyl-100
|
100 mg/5 mL
|
Syrup
|
Over-the-Counter (OTC) Drug
|
PET Round Amber Bottle with White HDPE Cap x 60 mL and 120 mL (Box of 1’s) PET Round Amber Bottle with White HDPE Cap x 10 mL (Physician’s Sample) (Box of 1’s)
|
Mucolytic
|
Enicar Pharmaceuticals Pvt. Ltd
|
India
|
N/A
|
Nelpa Lifesciences, Inc.
|
777 Red Pharma Inc.
|
CLIDP Conversion
|
09 January 2024
|
24 March 2026
|
| View |
|
DRP-9610
|
Aluminum Hydroxide + Magnesium Hydroxide
|
Neutrasaph
|
200mg/100mg per 5mL
|
Suspension
|
Over-the-Counter (OTC)
|
PET Round Amber Bottle with White HDPE Cap x 60 mL and 120 mL (Box of 1's)
|
-
|
Enicar Pharmaceuticals Pvt. Ltd.
|
India
|
Sapphire Lifesciences Pvt. Ltd.
|
Nelpa Lifesciences, Inc.
|
N/A
|
Initial (OTC)
|
24 March 2021
|
24 March 2026
|
| View |
|
DRP-9611
|
Loratadine
|
Lorasaph
|
10 mg
|
Tablet
|
Prescription Drug (RX)
|
Alu/Clear PVC Blister Pack x 10's (Box of 100's)
|
-
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
|
Nelpa Lifesciences, Inc.
|
|
Initial (OTC)
|
25 March 2021
|
25 March 2026
|
| View |
|
DRP-9612
|
Multivitamins + Iron
|
Ferrinova
|
Formulation Each Film-Coated Tablet contains: Ascorbic Acid (Vitamin C)-100 mg Pyridoxine (Vitamin B6)-10 mg Riboflavin (Vitamin B2)-3 mg Thiamine Mononitrate (Vitamin B1)-3 mg Cyanocobalamin (vitamin12-10mcg Folic Acid (Vitamin B9)-3 mg Iron
- 100 mg (equivalent to 314.30 mg Iron (III) Hydroxide Polymaltose Complex)
|
Tablet
|
Over-the-Counter (OTC)
|
Alu/Alu Blister Pack x 10's (Box of 30's and Box of 100's)
|
-
|
Saga Lifesciences Limited
|
India
|
|
Medinova Pharmaceutical, Inc.
|
|
Initial (OTC)
|
10 March 2022
|
25 March 2026
|
| View |
|
DRP-9613
|
Ascorbic Acid + Zinc + Cholecalciferol (Vitamin D3)
|
Preven-Z Gold Na
|
500 mg (equivalent to 605.20mg Calcium Ascorbate) 10 mg (equivalent to 70 mg Zinc Gluconate)/ 1,000 IU
|
Capsule
|
Over-the-Counter (OTC)
|
Alu-PVC/PVDC Amber Color Blister Pack x 10's
(Box of 100's)
|
-
|
Lloyd Laboratories, Inc.
|
Philippines
|
Innogen Pharmaceuticals, Inc.
|
|
|
-
|
25 March 2021
|
25 March 2026
|
| View |
|
DRP-9614
|
Ascorbic Acid + Zinc
|
Preven-Z Cal
|
500 mg (equivalent to 605.20 mg Calcium Ascorbate)/ 10 mg (equivalent to 70 mg Zinc Gluconate)
|
Capsule
|
Over-the-Counter (OTC)
|
Alu-PVC/PVDC Amber Color Blister Pack x 10's (Box of 100's)
|
Vitamins/Mineral
|
Lloyd Laboratories, Inc.
|
Philippines
|
Innogen Pharmaceuticals, Inc.
|
|
|
Initial (OTC)
|
25 March 2021
|
25 March 2026
|
| View |
|
DRP-9615
|
Telmisartan
|
Telmisaph-80
|
80 mg
|
Tablet
|
Prescription Drug (RX)
|
Alu/Alu Blister Pack x 10's (Box of 30's)
|
Angiotensin II Receptor Blocker
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
N/A
|
Nelpa Lifesciences, Inc.
|
Nelpa Lifesciences, Inc.
|
Initial
|
25 March 2021
|
25 March 2026
|
| View |
|
DRP-9615-01
|
Telmisartan
|
None
|
80 mg
|
Tablet
|
Prescription Drug (RX)
|
Alu/Alu Blister Pack x 10's (Box of 30's)
|
-
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
N/A
|
Nelpa Lifesciences, Inc.
|
Watsons Personal Care Stores (Philippines), Inc.
|
-
|
02 July 2021
|
25 March 2026
|
| View |
|
DRP-9615-02
|
Telmisartan
|
None
|
80 mg
|
Tablet
|
Prescription Drug (Rx)
|
Alu/Alu Blister Pack x 10's (Box of 30's)
|
-
|
Sapphire Lifesciences Pvt. Ltd
|
India
|
N/A
|
Nelpa Lifesciences Inc
|
ECE Pharmaceuticals, Inc.
|
CLIDP Conversion
|
13 December 2022
|
25 March 2026
|
| View |
|
DRP-9616
|
Telmisartan
|
Telmisaph-40
|
40 mg
|
Tablet
|
Prescription Drug (RX)
|
Alu/Alu Blister Pack x 10's (Box of 30's)
|
-
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
N/A
|
Nelpa Lifesciences, Inc.
|
Nelpa Lifesciences, Inc.
|
-
|
25 March 2021
|
25 March 2026
|
| View |
|
DRP-9616-01
|
Telmisartan
|
None
|
40 mg
|
Tablet
|
Prescription Drug (RX)
|
Alu/Alu Blister Pack x 10's (Box of 30's)
|
-
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
N/A
|
Nelpa Lifesciences, Inc.
|
Watsons Personal Care Stores (Philippines), Inc.
|
-
|
02 July 2021
|
25 March 2026
|
| View |
|
DRP-9616-04
|
Telmisartan
|
Telmixed
|
40 mg
|
Tablet
|
Prescription Drug (Rx)
|
Alu/Alu Blister Pack x 10’s (Box of 30's, 60's, 90's and 100's)
|
-
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
N/A
|
Nelpa Lifesciences, Inc.
|
777 Red Pharma Inc.
|
CLIDP Conversion
|
10 April 2023
|
25 March 2026
|
| View |
|
DRP-9616-05
|
Telmisartan
|
None
|
40 mg
|
Tablet
|
Prescription Drug (Rx)
|
Alu/Alu Blister Pack x 10's (Box of 30's)
|
Angiotensin II Receptor Blocker
|
Sapphire Lifesciences Pvt. Ltd
|
India
|
N/A
|
Nelpa Lifesciences,Inc.
|
Ambitech Biopharmaceuticals Inc
|
CLIDP Conversion
|
31 December 2023
|
25 March 2026
|