01 2ABBVIE
02 2ALLERGAN
03 1DR REDDYS
04 1ALPHARMA US PHARMS
05 1AM REGENT
06 2ANNORA PHARMA
07 1APTALIS PHARMA US
08 2AUROBINDO PHARMA USA
09 1BIONPHARMA
10 2COREPHARMA
11 1ENDO OPERATIONS
12 1FOSUN PHARMA
13 1FRESENIUS KABI USA
14 3HIKMA
15 1HIKMA PHARMS
16 2LANNETT
17 1NEXUS
18 1NOVITIUM PHARMA
19 2PIONEER PHARMS
20 1PRAXGEN PHARMS
21 1PRINSTON INC
22 1RENEW PHARMS
23 1RISING
24 1RUBICON
25 1SLATE RUN PHARMA
26 2SOMERSET THERAPS LLC
27 2SUN PHARM INDUSTRIES
28 2TWI PHARMS
29 4WATSON LABS
30 1WEST WARD
01 12CAPSULE;ORAL
02 14INJECTABLE;INJECTION
03 5SYRUP;ORAL
04 14TABLET;ORAL
01 16DISCN
02 28RX
03 1Blank
01 4BENTYL
02 1BENTYL PRESERVATIVE FREE
03 39DICYCLOMINE HYDROCHLORIDE
04 1DICYCLOMINE HYDROCHLORIDE (PRESERVATIVE FREE)
01 39No
02 5Yes
03 1Blank
RLD : Yes
TE Code :
Brand Name : BENTYL
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 10MG/ML
Approval Date : 1984-10-15
Application Number : 8370
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : BENTYL
Dosage Form : TABLET;ORAL
Dosage Strength : 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 1984-10-15
Application Number : 7409
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
RLD : No
TE Code :
Brand Name : DICYCLOMINE HYDROCHLORIDE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 10MG/ML
Approval Date : 1986-02-11
Application Number : 80614
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : Yes
TE Code :
Brand Name : BENTYL PRESERVATIVE FREE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 10MG/ML
Approval Date : 1984-10-15
Application Number : 8370
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : BENTYL
Dosage Form : CAPSULE;ORAL
Dosage Strength : 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 1984-10-15
Application Number : 7409
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : BENTYL
Dosage Form : SYRUP;ORAL
Dosage Strength : 10MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 1984-10-15
Application Number : 7961
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : No
TE Code : AB
Brand Name : DICYCLOMINE HYDROCHLORIDE
Dosage Form : TABLET;ORAL
Dosage Strength : 20MG
Approval Date : 1996-10-01
Application Number : 40161
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code : AB
Brand Name : DICYCLOMINE HYDROCHLORIDE
Dosage Form : TABLET;ORAL
Dosage Strength : 20MG
Approval Date : 1999-02-26
Application Number : 40230
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code : AB
Brand Name : DICYCLOMINE HYDROCHLORIDE
Dosage Form : CAPSULE;ORAL
Dosage Strength : 10MG
Approval Date : 1997-02-28
Application Number : 40204
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code : AA
Brand Name : DICYCLOMINE HYDROCHLORIDE
Dosage Form : SYRUP;ORAL
Dosage Strength : 10MG/5ML
Approval Date : 2005-03-24
Application Number : 40169
RX/OTC/DISCN : RX
RLD : No
TE Code : AA
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