| View |
|
DRP-9287
|
Ambroxol Hydrochloride
|
Mucosaph-Od
|
6mg/mL
|
Syrup (Oral Drops)
|
Over-the-Counter (OTC)
|
PET Round Amber Bottle with White HDPE Cap x
15 mL and 30 mL (Box of 1's)
|
Mucolytic
|
Enicar Pharmaceuticals Pvt. Ltd.
|
India
|
Sapphire Lifesciences Pvt. Ltd.
|
Nelpa Lifesciences, Inc.
|
|
-
|
16 November 2020
|
16 November 2025
|
| View |
|
DRP-9287-01
|
Ambroxol Hydrochloride
|
Couxol
|
6 mg/mL
|
Syrup (Oral Drops)
|
Over-the-Counter (OTC) Drug
|
PET Round Amber Bottle with White HDPE Cap x 15 mL and 30 mL (Box of 1's)
|
-
|
Enicar Pharmaceuticals Pvt. Ltd.
|
India
|
N/A
|
Nelpa Lifesciences, Inc.
|
Kaufmann Pharma Inc.
|
CLIDP Conversion
|
26 January 2023
|
16 November 2025
|
| View |
|
DRP-9287-03
|
Ambroxol Hydrochloride
|
Ambroxed-D
|
6 mg/mL
|
Syrup (Oral Drops)
|
Over-the-Counter (OTC) Drug
|
PET Round Amber Bottle with White HDPE Cap x 15 mL and 30 mL (Box of 1’s)
|
Mucolytic
|
Enicar Pharmaceuticals Pvt. Ltd.
|
India
|
N/A
|
Nelpa Lifesciences, Inc
|
777 Red Pharma Inc
|
CLIDP Conversion
|
10 January 2024
|
16 November 2025
|
| View |
|
DRP-9288
|
Ascorbic Acid + Zinc
|
Saphceevit-100
|
100 mg/10 mg (equivalent to 27.5 mg Zinc Sulfate
Monohydrate) per 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.
|
|
-
|
16 November 2020
|
16 November 2025
|
| View |
|
DRP-9289
|
Ascorbic Acid
|
Saphcorzee-500
|
500 mg
|
Sugar Coated Tablet
|
Over-the-Counter (OTC)
|
Alu/Dark Maroon Colored PVC Blister Pack x 10's
(Box of 100's)
|
-
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
|
Nelpa Lifesciences, Inc.
|
|
-
|
16 November 2020
|
16 November 2025
|
| View |
|
DRP-9290
|
Ascorbic Acid
|
Saphcorzee-1000
|
1000 mg
|
Sugar Coated Tablet
|
Over-the-Counter (OTC)
|
Alu/Dark Maroon Colored PVC Blister Pack x 10's
(Box of 100's)
|
-
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
|
Nelpa Lifesciences, Inc.
|
|
-
|
16 November 2020
|
16 November 2025
|
| View |
|
DRP-9291
|
Calcium Cholecalciferol (Vitamin D3)
|
Calcifesaph
|
600 mg (equivalent to 1.5g Calcium Carbonate)/10 mcg
(equivalent to 400 IU)
|
Film-Coated Tablet
|
Over-the-Counter (OTC) Drug
|
Alu/Clear PVC Blister Pack x 10's (Box of 100's)
|
Vitamin/Mineral
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
|
Nelpa Lifesciences, Inc.
|
Nelpa Lifesciences, Inc.
|
Initial [OTC] [Correction]
|
17 May 2024
|
16 November 2025
|
| View |
|
DRP-9292
|
Carbocisteine
|
Saphcisin-250
|
250mg/5mL
|
Syrup
|
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.
|
|
-
|
16 November 2020
|
16 November 2025
|
| View |
|
DRP-9292-01
|
Carbocisteine
|
Tussis-250
|
250 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)
|
Mucolytic
|
Enicar Pharmaceuticals Pvt. Ltd
|
India
|
N/A
|
Nelpa Lifesciences, Inc
|
Kaufmann Pharma Inc
|
CLIDP Conversion
|
19 January 2023
|
16 November 2025
|
| View |
|
DRP-9292-02
|
Carbocisteine
|
Carbocyl-250
|
250 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)
|
Mucolytic
|
Enicar Pharmaceuticals Pvt. Ltd.
|
India
|
N/A
|
Nelpa Lifesciences, Inc
|
777 Red Pharma Inc.
|
CLIDP Conversion
|
09 January 2024
|
16 November 2025
|
| View |
|
DRP-9293
|
Cetirizine Dihydrochloride
|
Rhinisaph-5
|
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.
|
|
-
|
16 November 2020
|
16 November 2025
|
| View |
|
DRP-9294
|
Cetirizine Hydrochloride
|
Cetrisaph-OD
|
2.5mg/mL
|
Syrup (Oral Drops)
|
Over-the-Counter (OTC)
|
PET Round Amber Bottle with White HDPE Cap x
15 mL and 30 mL with Medicine Dropper (Box of 1's)
|
-
|
Enicar Pharmaceuticals Pvt. Ltd.
|
India
|
Sapphire Lifesciences Pvt. Ltd.
|
Nelpa Lifesciences, Inc.
|
|
-
|
18 November 2020
|
18 November 2025
|
| View |
|
DRP-9294-02
|
Cetirizine hydrochloride
|
Cetired
|
2.5 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 Medicine Dropper (Box of 1’s)
|
Antihistamine
|
Enicar Pharmaceuticals Pvt. Ltd
|
India
|
N/A
|
Nelpa Lifesciences, Inc.
|
777 Red Pharma Inc.
|
CLIDP Conversion
|
10 January 2024
|
18 November 2025
|
| View |
|
DRP-9295
|
Ibuprofen
|
Ibusaph-200
|
200mg/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.
|
|
-
|
23 November 2020
|
23 November 2025
|
| View |
|
DRP-9295-02
|
Ibuprofen
|
Kidipan-200
|
200 mg/5 mL
|
Suspension
|
Over-the-Counter (OTC) Drug
|
PET Round Amber Bottle with 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
|
27 December 2023
|
23 November 2025
|
| View |
|
DRP-9296
|
Loratidine
|
Allersaph-5
|
5mg/5mL
|
Syrup
|
Over-The-Counter (OTC)
|
60 mL and 120 mL PET Round Amber Bottle with White HDPE Cap
|
-
|
Enicar Pharmaceuticals Pvt. Ltd.
|
India
|
Sapphire Lifesciences Pvt. Ltd.
|
Nelpa Lifesciences, Inc.
|
|
Initial
|
16 November 2020
|
16 November 2025
|
| View |
|
DRP-9296-01
|
Loratadine
|
Allos
|
5 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)
|
Antihistamine
|
Enicar Pharmaceuticals Pvt. Ltd.
|
India
|
N/A
|
Nelpa Lifesciences, Inc.
|
Kaufmann Pharma Inc
|
CLIDP Conversion
|
19 January 2023
|
16 November 2025
|
| View |
|
DRP-9296-02
|
Loratadine
|
Lorakalm Kids
|
5 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)
|
Antihistamine
|
Enicar Pharmaceuticals Pvt. Ltd
|
India
|
N/A
|
Nelpa Lifesciences, Inc.
|
Kaufmann Pharma Inc.
|
CLIDP Conversion
|
31 December 2023
|
16 November 2025
|
| View |
|
DRP-9297
|
Mefenamic Acid
|
Mefesaph-50
|
50mg/mL
|
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.
|
|
-
|
16 November 2020
|
16 November 2025
|
| View |
|
DRP-9298
|
Thiamine (Vitamin B1) + Pyridoxine (Vitamin B6) +
Cyanocobalamin (Vitamin B12)
|
Nervesaph
|
100mg/5mg/50mcg
|
Film Coated Tablet
|
Over-the-Counter (OTC)
|
Alu/Orange Colored PVC Blister Pack x 20's
(Box of 100's)
|
-
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
|
Nelpa Lifesciences, Inc.
|
|
-
|
16 November 2020
|
16 November 2025
|