View |
|
DRP-9420-02
|
Omeprazole
|
Jiaaprazole
|
40 mg
|
Delayed-Release Capsule
|
Prescription Drug (Rx)
|
Alu/Alu Blister Pack x 10's / (Box of 100's)
|
Proton Pump Inhibitor
|
Jiangxi Xierkangtai Pharmaceutical Co., Ltd.
|
China
|
|
PhilRx Pharma Inc
|
Jiaa Pharma
|
CLIDP Conversion
|
07 July 2024
|
05 December 2028
|
View |
|
DRP-9421
|
Ofloxacin
|
Oframac
|
400 mg
|
Film-Coated Tablet
|
Prescription Drug (RX)
|
Strip Foil x 10's (Box of 100's)
|
-
|
Lloyd Laboratories, Inc.
|
Philippines
|
Euro-Health Care Exponents, Inc.
|
|
TGP Pharma, Inc.
|
-
|
08 March 2021
|
18 January 2026
|
View |
|
DRP-9422
|
Zinc
|
Immunosaph-55
|
20 mg (equivalent to 55 mg Zinc Sulfate Monohydrate) per 5 mL
|
Syrup
|
Over-The-Counter (OTC)
|
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 10mL (Box of 1's) (Physician Sample)
|
Mineral
|
Enicar Pharmaceuticals Pvt. Ltd.
|
India
|
Sapphire Lifesciences Pvt. Ltd.
|
Nelpa Lifesciences, Inc.
|
|
Initial [OTC]
|
29 December 2020
|
29 December 2025
|
View |
|
DRP-9422-01
|
Zinc
|
Zinfate
|
20 mg (equivalent to 55 mg Zinc Sulfate Monohydrate) per 5mL Syrup
|
|
Over-the-Counter (OTC) Drug
|
PET Round Amber Bottle with white HDPE Cap x 60mL and 120mL (Box of 1's)
|
-
|
Enicar Pharmaceutical Pvt. Ltd
|
India
|
N/A
|
Nelpa Lifesciences, Inc
|
Kaufmann Pharma Inc
|
CLIDP Conversion
|
24 January 2023
|
29 December 2025
|
View |
|
DRP-9422-02
|
Zinc
|
Kalista
|
20 mg (equivalent to 55mg Zinc Sulfate Monohydrate) per 5 mL
|
Syrup
|
Over-the-Counter (OTC) Drug
|
PET Round Amber Bottle with White HDPE Cap x 60 mL (Box of 1’s)
|
Mineral
|
Enicar Pharmaceuticals Pvt. Ltd.
|
India
|
N/A
|
Nelpa Lifesciences, Inc
|
Kaufmann Pharma Inc
|
CLIDP Conversion
|
26 November 2023
|
29 December 2025
|
View |
|
DRP-9423
|
Zinc
|
Immunosaph-Od
|
10 mg/mL (equivalent to 27.5 mg Zinc Sulfate Monohydrate)
|
Syrup (Oral Drops)
|
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) (Pet Round Amber Bottle with White HDPE Cap X 15 mL (10 mL net content ) (Physician's Sample)
|
Mineral
|
Enicar Pharmaceuticals Pvt. Ltd.
|
India
|
Sapphire Lifesciences Pvt. Ltd.
|
Nelpa Lifesciences, Inc.
|
|
Initial [OTC]
|
29 December 2020
|
29 December 2025
|
View |
|
DRP-9423-01
|
Zinc
|
Zinfate-OD
|
10 mg/mL (equivalent to 27.5 mg Zinc Sulfate Monohydrate)
|
Syrup (Oral Drops)
|
Over-the-Counter (OTC) Drug
|
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
|
N/A
|
Nelpa Lifesciences, Inc.
|
Kaufmann Pharma Inc.
|
CLIDP Conversion
|
30 January 2023
|
29 December 2025
|
View |
|
DRP-9423-02
|
Zinc
|
Kalista OD
|
10 mg/mL (equivalent to 27.5 mg Zinc Sulfate Monohydrate)
|
Syrup (Oral Drops)
|
Over-the-Counter (OTC) Drug
|
PET Round Amber Bottle with White HDPE Cap x 15 mL and 30 mL with Plastic Dropper (Box of 1’s)
|
Mineral
|
Enicar Pharmaceuticals Pvt. Ltd
|
India
|
N/A
|
Nelpa Lifesciences, Inc.
|
Kaufmann Pharma Inc
|
CLIDP Conversion
|
26 November 2023
|
29 December 2025
|
View |
|
DRP-9424
|
Carbocisteine
|
Saphcisin-OD
|
50 mg/mL
|
Syrup (Oral Drops)
|
Over-The-Counter (OTC)
|
15 mL and 30 mL PET Round Amber Bottle with White HDPE Cap with Plastic Dropper\
|
-
|
Enicar Pharmaceuticals Pvt. Ltd.
|
India
|
Sapphire Lifesciences Pvt. Ltd.
|
Nelpa Lifesciences, Inc.
|
|
Initial [OTC]
|
29 December 2020
|
29 December 2025
|
View |
|
DRP-9424-01
|
Carbocisteine
|
Tussis-50
|
50 mg/mL
|
Syrup (Oral Drops)
|
Over-the-Counter (OTC) Drug
|
PET Round Amber Bottle with White HDPE Cap x 15 mL and 30 mL with Plastic Dropper (Box of 1's)
|
Mucolytic
|
Enicar Pharmaceuticals Pvt. Ltd
|
India
|
N/A
|
Nelpa Lifesciences, Inc.
|
Kaufmann Pharma Inc
|
CLIDP Conversion
|
19 January 2023
|
29 December 2025
|
View |
|
DRP-9425
|
Cetirizine Dihydrochloride
|
Rhinisaph-10
|
10mg/mL
|
Oral solution (Oral Drops)
|
Over-the-Counter (OTC)
|
PET Round Amber Bottle with White HDPE Cap x 10 mL,15 mL and 30 mL with Plastic Dropper (Box of l's)
|
-
|
Enicar Pharmaceuticals Pvt. Ltd.
|
India
|
Sapphire Lifesciences Pvt. Ltd.
|
Nelpa Lifesciences, Inc.
|
|
-
|
29 December 2020
|
29 December 2025
|
View |
|
DRP-9426
|
Ibuprofen
|
Saphrofen-OD
|
40mg/mL
|
Suspension (Oral Drops)
|
Over-the-Counter (OTC) Drug
|
PET Round Amber Bottle with White HDPE Cap x 15 mL and 30 mL with Plastic Dropper (Box of l’s)
|
-
|
Azine Healthcare Pvt. Ltd.
|
India
|
Sapphire Lifesciences Pvt. Ltd.
|
Nelpa Lifesciences, Inc.
|
|
-
|
07 January 2021
|
29 December 2025
|
View |
|
DRP-9427
|
Ibuprofen
|
Ibusaph-100
|
100mg/5mL
|
Suspension
|
Over-the-Counter (OTC)
|
PET Round Amber Bottle with White HDPE Cap x 60 mL and 120 mL (Box of l's)
|
-
|
Enicar Pharmaceuticals Pvt. Ltd.
|
India
|
Sapphire Lifesciences Pvt. Ltd.
|
Nelpa Lifesciences, Inc.
|
|
-
|
29 December 2020
|
29 December 2025
|
View |
|
DRP-9427-02
|
Ibuprofen
|
Kidipan-100
|
100 mg /5 mL
|
Suspension
|
Over-the-Counter (OTC) Drug
|
PET Round Amber Bottle with White HDPE Cap x 60 mL and 120 mL (Box of 1's)
|
Antipyretic/ Analgesic/ Non-Steroidal Anti-inflammatory Drug (NSAID)
|
Enicar Pharmaceuticals Pvt. Ltd.
|
India
|
N/A
|
Nelpa Lifesciences, Inc
|
Kaufmann Pharma Inc.
|
CLIDP Conversion
|
04 January 2024
|
29 December 2025
|
View |
|
DRP-9428
|
Guaifenesin
|
Bronchosaph-100
|
100mg/5mL
|
Syrup
|
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.
|
|
-
|
29 December 2020
|
29 December 2025
|
View |
|
DRP-9429
|
Phenylpropanolamine Hcl
|
Saphnolamine-12.5
|
12.5mg/5mL
|
Syrup
|
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.
|
|
-
|
29 December 2020
|
29 December 2025
|
View |
|
DRP-9430
|
Guaifenesin + Dextromethorphan HBr
|
Bronchosaph-DM
|
100 mg/15 mg per 5 mL
|
Syrup
|
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.
|
|
-
|
29 December 2020
|
29 December 2025
|
View |
|
DRP-9431
|
Multivitamins
|
Vitasaph
|
See Reverse formulation
|
Syrup
|
Over-The-Counter (OTC)
|
60 mL and 120 mL PET Round Amber Bottle with White HDPE Cap
|
Vitamins
|
Enicar Pharmaceuticals Pvt. Ltd.
|
India
|
Sapphire Lifesciences Pvt. Ltd.
|
Nelpa Lifesciences, Inc.
|
|
Initial [OTC]
|
29 December 2020
|
29 December 2025
|
View |
|
DRP-9432
|
Multivitamins
|
Vitasaph-OD
|
See Reverse formulation
|
Syrup (Oral Drops)
|
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
|
Sapphire Lifesciences Pvt. Ltd.
|
Nelpa Lifesciences, Inc.
|
|
-
|
29 December 2020
|
29 December 2025
|
View |
|
DRP-9433
|
Multivitamins + Iron
|
Vitronsaph-Fe
|
See Reverse formulation
|
Syrup
|
Over-The-Counter (OTC)
|
60 mL and 120 mL PET Round Amber Bottle with White HDPE Cap
|
Vitamins
|
Enicar Pharmaceuticals Pvt. Ltd.
|
India
|
Sapphire Lifesciences Pvt. Ltd.
|
Nelpa Lifesciences, Inc.
|
|
Initial [OTC]
|
29 December 2020
|
29 December 2025
|