01 1ALLERGAN
02 3DR REDDYS LABS SA
03 5MANKIND PHARMA
04 3ACCORD HLTHCARE
05 2ALCON
06 1ALCON LABS INC
07 3AMNEAL
08 2AMNEAL PHARMS
09 2ANI PHARMS
10 3ASPIRO
11 1AVET LIFESCIENCES
12 3BAXTER HLTHCARE CORP
13 3BE PHARMS
14 5CAPLIN
15 2CENCI
16 1CHARTWELL RX
17 3EUGIA PHARMA
18 3EXELA PHARMA
19 3FRESENIUS KABI USA
20 1G AND W LABS INC
21 1GENUS
22 1GENUS LIFESCIENCES
23 5GLAND
24 3HAINAN POLY
25 3HALEON US HOLDINGS
26 2HALSEY
27 7HIKMA
28 1LUPIN
29 3MEITHEAL
30 3MILLA PHARMS
31 2PARAGON BIOTECK
32 1PERRIGO R AND D
33 3PH HEALTH
34 1RAYNER SURGICAL
35 3SAGENT PHARMS INC
36 3SANDOZ
37 1SOMERSET THERAPS LLC
38 1WOCKHARDT
39 1XTTRIUM LABS INC
01 12SOLUTION/DROPS;OPHTHALMIC
02 61SOLUTION;INTRAVENOUS
03 2SOLUTION;IRRIGATION
04 16SYRUP;ORAL
05 4TABLET;ORAL
01 21DISCN
02 4OTC
03 70RX
01 1ADVIL ALLERGY AND CONGESTION RELIEF
02 1ADVIL CONGESTION RELIEF
03 1ADVIL MULTI-SYMPTOM COLD & FLU
04 2BIORPHEN
05 1CYCLOMYDRIL
06 1IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE
07 2IMMPHENTIV
08 1KETOROLAC TROMETHAMINE AND PHENYLEPHRINE HYDROCHLORIDE
09 1OMIDRIA
10 1PHENERGAN VC
11 1PHENERGAN VC W/ CODEINE
12 63PHENYLEPHRINE HYDROCHLORIDE
13 2PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE
14 1PHENYLEPHRINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE
15 1PHERAZINE VC
16 1PHERAZINE VC W/ CODEINE
17 1PREFRIN-A
18 1PROMETH HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE
19 1PROMETH VC PLAIN
20 1PROMETH VC W/ CODEINE
21 1PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE
22 1PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE
23 1PROMETHAZINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE
24 2PROMETHAZINE VC PLAIN
25 2PROMETHAZINE VC W/ CODEINE
26 3VAZCULEP
01 72No
02 23Yes
RLD : No
TE Code :
PHENYLEPHRINE HYDROCHLORIDE; PYRILAMINE MALEATE
Brand Name : PREFRIN-A
Dosage Form : SOLUTION/DROPS;OPHTHALMIC
Dosage Strength : 0.12%;0.1%
Approval Date : 1982-01-01
Application Number : 7953
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
RLD : Yes
TE Code : AP
Brand Name : BIORPHEN
Dosage Form : SOLUTION;INTRAVENOUS
Dosage Strength : 0.5MG/5ML (0.1MG/ML)
Approval Date : 2019-10-21
Application Number : 212909
RX/OTC/DISCN : RX
RLD : Yes
TE Code : AP
Delivering quality and niche Active Pharmaceutical Ingredients across the global from our USFDA-approved facility.
RLD : No
TE Code : AT
Brand Name : PHENYLEPHRINE HYDROCHLORIDE
Dosage Form : SOLUTION/DROPS;OPHTHALMIC
Dosage Strength : 10%
Approval Date : 2023-01-11
Application Number : 216496
RX/OTC/DISCN : RX
RLD : No
TE Code : AT
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
RLD : Yes
TE Code :
Brand Name : BIORPHEN
Dosage Form : SOLUTION;INTRAVENOUS
Dosage Strength : 10MG/ML (10MG/ML)
Approval Date : 2021-03-11
Application Number : 212909
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
RLD : Yes
TE Code :
Brand Name : PHENYLEPHRINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE
Dosage Form : SOLUTION;INTRAVENOUS
Dosage Strength : 20MG/250ML (0.08MG/ML)
Approval Date : 2025-05-30
Application Number : 216830
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
Delivering quality and niche Active Pharmaceutical Ingredients across the global from our USFDA-approved facility.
RLD : No
TE Code : AT
Brand Name : PHENYLEPHRINE HYDROCHLORIDE
Dosage Form : SOLUTION/DROPS;OPHTHALMIC
Dosage Strength : 2.5%
Approval Date : 2022-09-29
Application Number : 216859
RX/OTC/DISCN : RX
RLD : No
TE Code : AT
Delivering quality and niche Active Pharmaceutical Ingredients across the global from our USFDA-approved facility.
RLD : No
TE Code : AP1
Brand Name : PHENYLEPHRINE HYDROCHLORIDE
Dosage Form : SOLUTION;INTRAVENOUS
Dosage Strength : 10MG/ML (10MG/ML)
Approval Date : 2022-08-30
Application Number : 217069
RX/OTC/DISCN : RX
RLD : No
TE Code : AP1
Delivering quality and niche Active Pharmaceutical Ingredients across the global from our USFDA-approved facility.
RLD : No
TE Code : AP1
Brand Name : PHENYLEPHRINE HYDROCHLORIDE
Dosage Form : SOLUTION;INTRAVENOUS
Dosage Strength : 50MG/5ML (10MG/ML)
Approval Date : 2022-08-30
Application Number : 217069
RX/OTC/DISCN : RX
RLD : No
TE Code : AP1
Delivering quality and niche Active Pharmaceutical Ingredients across the global from our USFDA-approved facility.
RLD : No
TE Code : AP1
Brand Name : PHENYLEPHRINE HYDROCHLORIDE
Dosage Form : SOLUTION;INTRAVENOUS
Dosage Strength : 100MG/10ML (10MG/ML)
Approval Date : 2022-08-30
Application Number : 217069
RX/OTC/DISCN : RX
RLD : No
TE Code : AP1
RLD : Yes
TE Code :
CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE
Brand Name : PHENERGAN VC W/ CODEINE
Dosage Form : SYRUP;ORAL
Dosage Strength : 10MG/5ML;5MG/5ML;6.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 1984-04-02
Application Number : 8306
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
