01 9SCHERING
02 3AIPING PHARM INC
03 4ALVOGEN
04 1AMNEAL
05 3ANDAS 5 HOLDING
06 4APOTHECON
07 4APPCO
08 1BAXTER HLTHCARE CORP
09 3CADILA PHARMS LTD
10 1CAPLIN
11 3EPIC PHARMA LLC
12 1GLAND PHARMA LTD
13 4GLAXOSMITHKLINE
14 4HERITAGE PHARMA
15 3HIBROW HLTHCARE
16 7HIKMA
17 3HOSPIRA
18 3MACLEODS PHARMS LTD
19 1ONESOURCE SPECIALTY
20 3PH HEALTH
21 2RISING
22 3RUBICON RESEARCH
23 1SEBELA IRELAND LTD
24 3TEVA
25 3UNICHEM
26 3WATSON LABS
27 3ZYDUS PHARMS
01 14INJECTABLE;INJECTION
02 6SOLUTION;INTRAVENOUS
03 63TABLET;ORAL
01 32DISCN
02 51RX
01 61LABETALOL HYDROCHLORIDE
02 1LABETALOL HYDROCHLORIDE IN DEXTROSE
03 3LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE
04 5NORMODYNE
05 4NORMOZIDE
06 5TRANDATE
07 4TRANDATE HCT
01 67No
02 16Yes
RLD : Yes
TE Code :
Brand Name : NORMODYNE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 1984-08-01
Application Number : 18686
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : NORMODYNE
Dosage Form : TABLET;ORAL
Dosage Strength : 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 1987-08-31
Application Number : 18687
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : NORMODYNE
Dosage Form : TABLET;ORAL
Dosage Strength : 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 1984-08-01
Application Number : 18687
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : NORMODYNE
Dosage Form : TABLET;ORAL
Dosage Strength : 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 1984-08-01
Application Number : 18687
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : NORMODYNE
Dosage Form : TABLET;ORAL
Dosage Strength : 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 1984-08-01
Application Number : 18687
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : No
TE Code :
HYDROCHLOROTHIAZIDE; LABETALOL HYDROCHLORIDE
Brand Name : NORMOZIDE
Dosage Form : TABLET;ORAL
Dosage Strength : 25MG;100MG
Approval Date : 1987-04-06
Application Number : 19046
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
HYDROCHLOROTHIAZIDE; LABETALOL HYDROCHLORIDE
Brand Name : NORMOZIDE
Dosage Form : TABLET;ORAL
Dosage Strength : 25MG;200MG
Approval Date : 1987-04-06
Application Number : 19046
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
HYDROCHLOROTHIAZIDE; LABETALOL HYDROCHLORIDE
Brand Name : NORMOZIDE
Dosage Form : TABLET;ORAL
Dosage Strength : 25MG;300MG
Approval Date : 1987-04-06
Application Number : 19046
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
HYDROCHLOROTHIAZIDE; LABETALOL HYDROCHLORIDE
Brand Name : NORMOZIDE
Dosage Form : TABLET;ORAL
Dosage Strength : 25MG;400MG
Approval Date : 1987-04-06
Application Number : 19046
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : Yes
TE Code :
Brand Name : TRANDATE
Dosage Form : TABLET;ORAL
Dosage Strength : 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 1985-05-24
Application Number : 18716
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
