| View |
|
DRP-9366
|
Guaifenesin
|
Saphfenesin-100
|
100mg/5mL
|
Syrup
|
Over-the-Counter (OTC)
|
PET Round Amber Bottle with White HDPE Cap x
60 mL and 120 mL (Box of l's)
|
-
|
Azine Healthcare Pvt. Ltd.
|
India
|
Sapphire Lifesciences Pvt. Ltd.
|
Nelpa Lifesciences, Inc.
|
|
-
|
15 December 2020
|
15 December 2025
|
| View |
|
DRP-9367
|
Ibuprofen
|
Ibusaph-Od
|
40mg/mL
|
Suspension (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.
|
|
-
|
15 December 2020
|
15 December 2025
|
| View |
|
DRP-9367-02
|
Ibuprofen
|
Kidipan OD
|
40 mg/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 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
|
15 December 2025
|
| View |
|
DRP-9368
|
Sodium Fusidate
|
Fucisaph-Na
|
20mg/g
|
Ointment
|
Over-the-Counter (OTC) Drug
|
Aluminum Collapsible Tube x 5g, 10g, 15g, 20g, and 30g (Box of l’s)
|
-
|
Azine Healthcare Pvt. Ltd.
|
India
|
Sapphire Lifesciences Pvt. Ltd.
|
Nelpa Lifesciences, Inc.
|
|
Initial (OTC) Correction
|
09 February 2023
|
15 December 2025
|
| View |
|
DRP-9369
|
Ibuprofen
|
Saphrofen-100
|
100 mg/5mL
|
Suspension
|
Over-the-Counter (OTC)
|
PET Round Amber Bottle with White HDPE Cap x 60 mL and 120 mL (Box of l's)
|
-
|
Azine Healthcare Pvt. Ltd.
|
India
|
Sapphire Lifesciences Pvt. Ltd.
|
Nelpa Lifesciences, Inc.
|
|
-
|
15 December 2020
|
15 December 2025
|
| View |
|
DRP-937
|
50% Dextrose
|
None
|
25gm/50mL (0.5g/Ml)
|
Solution for Injection
|
Prescription Drug (RX)
|
Clear glass vial X 50mL
|
Caloric Agent
|
Best Drug Industries, Inc.
|
Philippines
|
|
|
|
Renewal
|
13 March 2024
|
27 August 2029
|
| View |
|
DRP-9370
|
Dextromethorphan Hbr
|
Robisaph-Dm
|
10mg/5mL
|
Syrup
|
Over-the-Counter (OTC)
|
PET Round Amber Bottle with White HDPE Cap x 60 mL and 120 mL (Box of 1's)
|
-
|
Azine Healthcare Pvt. Ltd.
|
India
|
Sapphire Lifesciences Pvt. Ltd.
|
Nelpa Lifesciences, Inc.
|
|
-
|
15 December 2020
|
15 December 2025
|
| View |
|
DRP-9371
|
Hyoscine-N-Butylbromide
|
Hyosaph-S
|
1mg/mL
|
Syrup
|
Over-the-Counter (OTC)
|
PET Round Amber Bottle with White HDPE Cap x 60 mL and 120 mL (Box of l's)
|
-
|
Azine Healthcare Pvt. Ltd.
|
India
|
Sapphire Lifesciences Pvt. Ltd.
|
Nelpa Lifesciences, Inc.
|
|
-
|
15 December 2020
|
15 December 2025
|
| View |
|
DRP-9372
|
Phenylpropanolamine Hcl
|
Saphgest-Od
|
6.25 mg/mL
|
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)
|
-
|
Azine Healthcare Pvt. Ltd.
|
India
|
Sapphire Lifesciences Pvt. Ltd.
|
Nelpa Lifesciences, Inc.
|
|
-
|
15 December 2020
|
15 December 2025
|
| View |
|
DRP-9373
|
Phenylpropanolamine Hcl
|
Saphgest
|
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)
|
-
|
Azine Healthcare Pvt. Ltd.
|
India
|
Sapphire Lifesciences Pvt. Ltd.
|
Nelpa Lifesciences, Inc.
|
|
-
|
15 December 2020
|
15 December 2025
|
| View |
|
DRP-9374
|
Diphenhydramine Hydrochloride
|
Saphredyl
|
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)
|
-
|
Azine Healthcare Pvt. Ltd.
|
India
|
Sapphire Lifesciences Pvt. Ltd.
|
Nelpa Lifesciences, Inc.
|
|
-
|
15 December 2020
|
15 December 2025
|
| View |
|
DRP-9375
|
Mometason Furoate
|
Mometasaph
|
1mg/g
|
Cream
|
Over-the-Counter (OTC)
|
Aluminum Collapsible Tube x 5g, 10g, 15g, 20g, and
30g (Box of 1's)
|
-
|
Azine Healthcare Pvt. Ltd.
|
India
|
Sapphire Lifesciences Pvt. Ltd.
|
Nelpa Lifesciences, Inc.
|
|
-
|
15 December 2020
|
15 December 2025
|
| View |
|
DRP-9376
|
Guaifenesin + Phenylpropanolamine HCl + Chlorphenamine maleate
|
Saphextorant-Plus
|
100 mg/6.5 mg/2 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)
|
-
|
Azine Healthcare Pvt. Ltd.
|
India
|
Sapphire Lifesciences Pvt. Ltd.
|
Nelpa Lifesciences, Inc.
|
|
-
|
07 January 2021
|
15 December 2025
|
| View |
|
DRP-9377
|
Guaifenesin + Phenylpropanolamine Hcl+ Chlorphenamine Maleate
|
Saphextorant
|
100mg/5mg/2mg 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)
|
-
|
Azine Healthcare Pvt. Ltd.
|
India
|
Sapphire Lifesciences Pvt. Ltd.
|
Nelpa Lifesciences, Inc.
|
|
-
|
15 December 2020
|
15 December 2025
|
| View |
|
DRP-9378
|
Carbocisteine
|
Carbosaph-Od
|
50 mg/mL
|
Syrup (Oral Drops)
|
Over-the-Counter (OTC)
|
15 mL and 30 mL with Plastic Dropper (Box of 1's)
|
-
|
Azine Healthcare Pvt. Ltd.
|
India
|
Sapphire Lifesciences Pvt. Ltd.
|
Nelpa Lifesciences, Inc.
|
|
-
|
15 December 2020
|
15 December 2025
|
| View |
|
DRP-9379
|
Cetirizine Dihydrochloride
|
Saphzine-10
|
10mg/mL
|
Syrup (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)
|
-
|
Azine Healthcare Pvt. Ltd.
|
India
|
Sapphire Lifesciences Pvt. Ltd.
|
Nelpa Lifesciences, Inc.
|
|
-
|
15 December 2020
|
15 December 2025
|
| View |
|
DRP-9380
|
Co-Amoxiclav
|
Augmeed 457
|
457mg/5mL
|
Powder for Oral Suspension
|
Prescription Drug (Rx)
|
HDPE plastic bottle with 15 mL measuring cup x 70
mL (Box of 1's)
|
-
|
Medopharm Private Limited
|
India
|
|
MedEthix, Inc.
|
I.E. Medica Inc.
|
-
|
16 December 2020
|
16 December 2025
|
| View |
|
DRP-9380-01
|
Co-Amoxiclav
|
Amixlo
|
457 mg/5mL
|
Powder for Oral Suspension
|
Prescription Drug (Rx)
|
HDPE plastic bottle with 15mL measuring cup x 70 mL (Box of 1's)
|
Antibacterial (Penicillin/Beta-lactamase Inhibitor)
|
Medopharm Private Limited
|
India
|
N/A
|
Medethix,Inc.
|
Amediqo Phils., Inc.
|
CLIDP Conversion
|
27 December 2023
|
16 December 2025
|
| View |
|
DRP-9381
|
Co-Amoxiclav
|
Cledomox 457 DS
|
457mg/5mL
|
Powder for Oral Suspension
|
Prescription Drug (Rx)
|
HDPE plastic bottle with 15 mL measuring cup x 70
mL (Box of 1's)
|
-
|
Medopharm Private Limited
|
India
|
|
MedEthix, Inc.
|
MedEthix, Inc.
|
-
|
16 December 2020
|
16 December 2025
|
| View |
|
DRP-9382
|
Ambroxol
|
Nomoflem
|
30 mg
|
Tablet
|
Over-the-Counter (OTC)
|
Alu/PVC Blister x 10's and 20's (Box of 100's)
|
-
|
Lifesquare Laboratories Inc.
|
Philippines
|
|
|
|
-
|
17 December 2020
|
17 December 2025
|