01 6ABBVIE
02 2ABBVIE INC
03 1DR REDDYS LABS SA
04 1ACTAVIS LABS FL INC
05 2AJANTA PHARMA LTD
06 2ALEMBIC
07 2ANI PHARMS
08 2AUROBINDO
09 2CHARTWELL
10 1CUMBERLAND
11 2ESJAY PHARMA
12 2HEC PHARM
13 2HIKMA
14 2IVAX SUB TEVA PHARMS
15 1LUPIN LTD
16 2NORVIUM BIOSCIENCE
17 1NOSTRUM LABS INC
18 1RANBAXY
19 1RISING
20 5SANDOZ
21 4SUN PHARM INDS LTD
22 1SUNSHINE
23 1TAKEDA PHARMS USA
24 2TEVA
25 2WOCKHARDT
01 4CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS;ORAL
02 1CAPSULE, TABLET, CAPSULE, DELAYED RELEASE;ORAL
03 7FOR SUSPENSION;ORAL
04 8TABLET, EXTENDED RELEASE;ORAL
05 30TABLET;ORAL
01 28DISCN
02 20RX
03 2Blank
01 5BIAXIN
02 3BIAXIN XL
03 37CLARITHROMYCIN
04 3LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED)
05 1OMECLAMOX-PAK
06 1PREVPAC (COPACKAGED)
01 41No
02 7Yes
03 2Blank
RLD : Yes
TE Code :
Brand Name : BIAXIN
Dosage Form : TABLET;ORAL
Dosage Strength : 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 1991-10-31
Application Number : 50662
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 : AB
Brand Name : CLARITHROMYCIN
Dosage Form : TABLET, EXTENDED RELEASE;ORAL
Dosage Strength : 500MG
Approval Date : 2005-05-18
Application Number : 65154
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : Yes
TE Code :
Brand Name : BIAXIN
Dosage Form : TABLET;ORAL
Dosage Strength : 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 1991-10-31
Application Number : 50662
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD :
TE Code :
Brand Name : BIAXIN XL
Dosage Form : TABLET;ORAL
Dosage Strength : 250MG
Approval Date :
Application Number : 50697
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
TE Code :
Brand Name : BIAXIN XL
Dosage Form : TABLET;ORAL
Dosage Strength : 500MG
Approval Date :
Application Number : 50697
RX/OTC/DISCN :
RLD :
TE Code :
RLD : Yes
TE Code :
Brand Name : BIAXIN
Dosage Form : FOR SUSPENSION;ORAL
Dosage Strength : 125MG/5ML
Approval Date : 1993-12-23
Application Number : 50698
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : BIAXIN
Dosage Form : FOR SUSPENSION;ORAL
Dosage Strength : 250MG/5ML
Approval Date : 1993-12-23
Application Number : 50698
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : No
TE Code :
Brand Name : BIAXIN
Dosage Form : FOR SUSPENSION;ORAL
Dosage Strength : 187MG/5ML
Approval Date : 1998-09-30
Application Number : 50698
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : Yes
TE Code :
Brand Name : BIAXIN XL
Dosage Form : TABLET, EXTENDED RELEASE;ORAL
Dosage Strength : 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 2000-03-03
Application Number : 50775
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : Yes
TE Code :
AMOXICILLIN; CLARITHROMYCIN; LANSOPRAZOLE
Brand Name : PREVPAC (COPACKAGED)
Dosage Form : CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS;ORAL
Dosage Strength : 500MG;500MG;30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 1997-12-02
Application Number : 50757
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
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