| View |
|
DRP-935-01
|
Phenylpropanolamine Hydrochloride + Chlorphenamine Maleate
|
Phenycol
|
25 mg/2 mg
|
Tablet
|
Prescription Drug (RX)
|
Alu/PVC Blistr Pack x 20's (Box of 100's)
|
Nasal Decongestant / Antihistamine
|
Lloyd Laboratories,Inc.
|
Philippines
|
Interhealthcare Pharmaceuticals, Inc.
|
|
TGP Pharma, Inc.
|
Renewal
|
25 July 2024
|
04 October 2029
|
| View |
|
DRP-9350
|
Salbutamol (as sulfate)
|
Azmasol
|
100 mcg/actuation
|
Suspension Metered Dose Inhaler
|
Prescription Drug (RX)
|
Aluminum canister with plastic metering valve and
polypropylene plastic actuator with dust cap x 200 actuations (Box of l's)
|
-
|
Beximco Pharmaceuticals Ltd.
|
Bangladesh
|
|
Ambica International Corporation
|
Ambica International Corporation
|
-
|
04 December 2020
|
04 December 2025
|
| View |
|
DRP-9350-01
|
Salbutamol (As Sulfate)
|
Salmate
|
10 mcg per actuation
|
Suspension Metered Dose Inhaler
|
Prescription Drug (RX)
|
Aluminum canister with plastic metering valve and
Polypropylene Plastic Actuator with Dust Cap x 200 actuations (Box of 1's)
|
-
|
Beximco Pharmaceuticals Ltd.
|
Bangladesh
|
|
Ambica International Corporation
|
Preventia Healthcare Inc.
|
-
|
24 August 2021
|
04 December 2025
|
| View |
|
DRP-9350-02
|
Salbutamol (As Sulfate)
|
Asmaler
|
100 mcg per actuation
|
Suspension Metered Dose Inhaler
|
Prescription Drug (RX)
|
Aluminum canister with plastic metering valve and
polypropylene plastic actuator with dust cap x 200 actuations (Box of l's)
|
Selective Beta-2-Adrenoreceptor Agonist
|
Beximco Pharmaceuticals Ltd.
|
Bangladesh
|
|
Ambica International Corporation
|
999 Seth Pharmaceutical Inc.
|
CLIDP
|
27 October 2021
|
04 December 2025
|
| View |
|
DRP-9350-04
|
Salbutamol (as sulfate)
|
Spasmazol
|
100 mcg per actuation Suspension Metered Dose Inhaler
|
|
Prescription Drug (Rx)
|
Aluminum canister with plastic metering valve and polypropylene plastic actuator with dust cap x 200 actuations (Box of 1's)
|
Selective Beta-2-adrenoreceptor Agonist
|
Beximco Pharmaceuticals Ltd
|
Bangladesh
|
N/A
|
Ambica International Corporation
|
AGB Pharmaceutical Trading and Consultancy Corporation
|
-
|
07 April 2022
|
04 December 2025
|
| View |
|
DRP-9350-05
|
Salbutamol (as sulfate)
|
Saltracit
|
100 mcg per actuation
|
Suspension Metered Dose Inhaler
|
Prescription Drug (Rx)
|
Aluminum canister with plastic metering valve and polypropylene plastic actuator with dust cap x 200 actuations (Box of 1's)
|
Selective Beta-2-adrenoreceptor Agonist
|
Beximco Pharmaceuticals Ltd.
|
Bangladesh
|
N/A
|
Ambica International Corporation
|
Diafarm Inc.
|
CLIDP Conversion
|
07 April 2022
|
04 December 2025
|
| View |
|
DRP-9350-06
|
Salbutamol (as sulfate)
|
None
|
100 mcg per actuation
|
Suspension Metered Dose Inhaler
|
Prescription Drug (Rx)
|
Aluminum canister with plastic metering valve and polypropylene plastic actuator with dust cap x 200 actuations (Box of 1's)
|
Selective Beta-2-adrenoreceptor Agonist
|
Beximco Pharmaceuticals Ltd.
|
Bangladesh
|
N/A
|
Ambica International Corporation
|
TGP Pharma Inc.
|
CLIDP Conversion
|
25 August 2022
|
04 December 2025
|
| View |
|
DRP-9351
|
Granisetron (hydrochloride)
|
Grakytil
|
1 mg/mL (3 mg/3mL)
|
Solution for I.V. Injection or
Infusion
|
Prescription Drug (RX)
|
Type I clear and colorless glass ampoule with red-yellow
ring x 3 mL (Box of 5's)
|
-
|
Mefar Ilac Sanayii A.S.
|
Turkey
|
Pharmada Ilac San. Ve Tic, A.S.
|
Ambica Intermational Corporation
|
Ambica Intermational Corporation
|
-
|
04 December 2020
|
04 December 2025
|
| View |
|
DRP-9351-01
|
Granisetron (hydrochloride)
|
Grani-Ace
|
1 mg/mL (3 mg/3 mL)
|
Solution for I.V. Injection or Infusion
|
Prescription Drug (RX)
|
Type I clear and colorless glass ampoule with red-yellow ring x 3 mL (Box of 5's)
|
Antiemetic and Antinauseant (Serotonin (5HT3) antagonist)
|
Mefar Ilac Sanayii A.S.
|
Turkey
|
N/A
|
Ambica International Corporation
|
Genace Pharma Distributor
|
-
|
26 January 2022
|
04 December 2025
|
| View |
|
DRP-9352
|
Dorzolamide ( As Hydrochloride ) + Timolol ( As Maleate )
|
Episopt
|
20 mg/5 mg per mL (2%/0.5% w/v)
|
Sterile Ophthalmic
Solution (Eye Drops)
|
Prescription Drug (RX)
|
Low Density Polyethylene (LDPE) plastic bottle with
dropper and High Density Polyethylene (HDPE) Plastic Tamper Proof Opaque White Screw Cap x 5 mL (Box of 1's)
|
-
|
Egyptian International Pharmaceutical Industries Co.
(EIPICO)
|
Egypt
|
|
Ambica International Corporation
|
Ambica International Corporation
|
Initial (Correction)
|
18 January 2023
|
04 December 2025
|
| View |
|
DRP-9353
|
Ceftriaxone
|
None
|
1 g
|
Powder for Injection (I.M./I.V.)
|
Prescription Drug (Rx)
|
USP Type 1 flint glass vial sealed with 20 mm grey
bromo butyl rubber stopper and a flip off aluminum seal (Box of 1's)
Packaging
|
-
|
Inject Care Parenterals Pvt. Ltd.
|
India
|
Rainbow Life Sciences Pvt. Ltd.
|
Ambica International Corporation
|
Ambica International Corporation
|
-
|
04 December 2020
|
04 December 2025
|
| View |
|
DRP-9354
|
Betahistine dihydrochloride
|
Dizimarc
|
16 mg
|
Tablet
|
Prescription Drug (RX)
|
Alu/Alu blister pack x 10 (Box of 100's)
|
-
|
Healer's Lab (Unit II)
|
India
|
|
Raquel-Abbas Pharmaceuticals & General
Merchandise
|
Raquel-Abbas Pharmaceuticals & General
Merchandise
|
-
|
04 December 2020
|
04 December 2025
|
| View |
|
DRP-9354-01
|
Betahistine dihydrochloride
|
Betaquest
|
16 mg
|
Tablet
|
Prescription Drug (Rx)
|
Alu/Alu blister pack x 10 / (Box of 100's)
|
Anti-vertigo
|
Healer's Lab (Unit II)
|
India
|
|
Raquel-Abbas Pharmaceuticals & General Merchandise
|
Health-Quest Pharma and Medical Supplies Trading
|
CLIDP Conversion
|
25 March 2024
|
04 December 2025
|
| View |
|
DRP-9355
|
Betahistine dihydrochloride
|
Dizimarc
|
8 mg
|
Tablet
|
Prescription Drug (RX)
|
Alu-Alu Blister pack x 10 (Box of 100 Tablets)
|
-
|
Healer's Lab (Unit II)
|
India
|
|
Raquel-Abbas Pharmaceuticals & General Merchandise
|
Raquel-Abbas Pharmaceuticals & General Merchandise
|
-
|
04 December 2020
|
04 December 2025
|
| View |
|
DRP-9356
|
Hyoscine-N-Butylbromide
|
Hyophil
|
20mg/mL
|
Solution For Injection (I.M./I.V./S.C.)
|
Prescription Drug (RX)
|
USP Type I amber colour glass ampoule x 1 mL
(Box of 10's)
|
-
|
Farbe Firma
|
India
|
|
AMB HK Enterprises Inc.
|
AMB HK Enterprises Inc.
|
Initial
|
11 December 2020
|
11 December 2025
|
| View |
|
DRP-9356-01
|
Hyoscine-N-Butylbromide
|
Iscopan
|
20 mg/mL
|
Solution for Injection (IM/IV/SC)
|
Prescription Drug (RX)
|
USP Type I Amber Colour Glass Ampoule x 1 mL
(Box of 10's)
|
-
|
Farbe Firma
|
India
|
|
AMB HK Enterprises Inc.
|
PhilRx Pharma Inc.
|
Initial (Reissuance)
|
29 July 2022
|
11 December 2025
|
| View |
|
DRP-9356-02
|
Hyoscine-N-Butylbromide
|
Hyoden
|
20 mg/mL
|
Solution for Injection (I.M./I.V./S.C.)
|
Prescription Drug (Rx)
|
USP Type I amber glass ampoule x 1 mL (Box of 10's)
|
Anticholingeric
|
Farbe Firma
|
India
|
|
AMB HK Enterprises Inc.
|
Cyden Medicale Trading Inc.
|
CLIDP Conversion
|
09 February 2023
|
11 December 2025
|
| View |
|
DRP-9357
|
Oxcarbazepine
|
Exvul-600
|
600 mg
|
Film-Coated Tablet
|
Prescription Drug (RX)
|
Alu/PVC blister pack of 10's (Box of 30's, 50's, and
100's)
|
-
|
Stallion Laboratories Pvt. Ltd.
|
India
|
|
Ambica International Corporation
|
Ambica International Corporation
|
-
|
10 December 2020
|
10 December 2025
|
| View |
|
DRP-9358
|
Oxcarbazepine
|
Exvul-300
|
300 mg
|
Film-Coated Tablet
|
Prescription Drug (RX)
|
Alu/PVC blister pack of 10's (Box of 30's, 50's, and
100's)
|
-
|
Stallion Laboratories Pvt. Ltd.
|
India
|
|
Ambica International Corporation
|
Ambica International Corporation
|
-
|
10 December 2020
|
10 December 2025
|
| View |
|
DRP-9359
|
Rocuronium bromide
|
Muscoron
|
10 mg/mL (50 mg/5 mL)
|
Solution for Injection (I.V.)
|
Prescription Drug (RX)
|
5 mL-capacity USP Type I clear and colorless glass vial with grey chlorobutyl rubber stopper and red- colored aluminum seal with yellow-colored flip-off cap (Box of 10's)
|
Muscle Relaxant
|
Maiva Pharma Private Limited
|
India
|
Adi Solutions Pty Ltd.
|
Med Ethix, Inc.
|
Med Ethix, Inc.
|
Initial (Reconstruction)
|
12 August 2024
|
04 December 2025
|