01 3Allergan Aesthetics
02 7LGM Pharma
03 4Dr. Reddy's Laboratories
04 8Mikart
05 9Strides Pharma Science
06 5Granules India Limited
07 1ABHAI LLC
08 9Actavis Inc
09 3Alvogen
10 3Aralez Pharmaceuticals
11 1Aurolife Pharma LLC
12 3Bausch Health
13 1DUNHALL
14 1Esjay Pharma
15 2Forest Laboratories
16 1Fosun Pharmaceutical
17 2HALSEY
18 9Hikma Pharmaceuticals
19 1IVAX Pharmaceuticals Inc
20 1Jerome Stevens Pharmaceuticals
21 1Key Therapeutics
22 1LABORATOIRE RIVA INC.
23 2LARKEN LABS
24 2Laboratoires Gilbert
25 4Lannett Company, Inc.
26 1MAYRAND
27 9Mallinckrodt Pharmaceuticals
28 1Mirror Pharmaceuticals LLC
29 1NE RX PHARMA
30 1Nesher Pharmaceuticals USA LLC
31 2Nostrum Laboratories
32 1Novast Laboratories
33 1Nuvo Pharmaceuticals
34 1PURACAP PHARM
35 1QUANTUM PHARMICS
36 5Quagen Pharma
37 1SHIRE PLC
38 1Sandoz B2B
39 1Savage Lab
40 5Senores Pharmaceuticals
41 5Sun Pharmaceutical Industries Limited
42 1Taro Pharmaceutical Industries
43 4Teva Pharmaceutical Industries
44 1US CHEM
45 1Vintage Pharmaceuticals-Charlotte
01 6CAPSULE
02 56CAPSULE;ORAL
03 1Capsule; Oral
04 2Immediate Release Capsule
05 1SOLUTION;ORAL
06 2TABLET
07 55TABLET;ORAL
08 5Tablet
01 64DISCN
02 4Narcotic (CDSA I)
03 1ROW, US
04 48RX
05 4Schedule G (CDSA IV)
06 7Blank
01 1ALLZITAL
02 1ANOQUAN
03 1AXOTAL
04 1BANCAP
05 1BUCET
06 15BUTALBITAL AND ACETAMINOPHEN
07 47BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
08 8BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE
09 12BUTALBITAL, ASPIRIN AND CAFFEINE
10 5BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE
11 1BUTALBITAL; ACETAMINOPHEN; CAFFEINE; CODEINE
12 2BUTAPAP
13 1ESGIC
14 2ESGIC-PLUS
15 1FEMCET
16 1FIORICET W/ CODEINE
17 3FIORINAL
18 1FIORINAL W/CODEINE
19 1FIORINAL-C 1/2
20 1FIORINAL-C 1/4
21 2LANORINAL
22 1MEDIGESIC PLUS
23 1PHRENILIN
24 1PHRENILIN FORTE
25 1PHRENILIN WITH CAFFEINE AND CODEINE
26 1SEDAPAP
27 1TENCON
28 2TEVA-TECNAL
29 1TEVA-TECNAL C 1/2
30 1TEVA-TECNAL C 1/4
31 1TRIAD
32 1TRIANAL TABLET
33 1TRIAPRIN
34 7Blank
01 8Canada
02 7India
03 113USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : FIORINAL
Dosage Form : TABLET;ORAL
Dosage Strength : 325MG;50MG;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Packaging :
Approval Date : 1986-04-16
Application Number : 17534
Regulatory Info : DISCN
Registration Country : USA
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Regulatory Info : RX
Registration Country : USA
ACETAMINOPHEN; BUTALBITAL; CAFFEINE
Brand Name : BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
Dosage Form : CAPSULE;ORAL
Dosage Strength : 300MG;50MG;40MG
Packaging :
Approval Date : 2009-11-16
Application Number : 40885
Regulatory Info : RX
Registration Country : USA
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Regulatory Info : RX
Registration Country : USA
ACETAMINOPHEN; BUTALBITAL; CAFFEINE
Brand Name : BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
Dosage Form : CAPSULE;ORAL
Dosage Strength : 325MG;50MG;40MG
Packaging :
Approval Date : 1986-03-17
Application Number : 89007
Regulatory Info : RX
Registration Country : USA
As a CDMO, Mikart offers integrated CDMO services for Solid Dose & Non-sterile Liquid formulations.
Regulatory Info : DISCN
Registration Country : USA
ACETAMINOPHEN; BUTALBITAL; CAFFEINE
Brand Name : ESGIC-PLUS
Dosage Form : CAPSULE;ORAL
Dosage Strength : 500MG;50MG;40MG
Packaging :
Approval Date : 1996-03-28
Application Number : 40085
Regulatory Info : DISCN
Registration Country : USA
Strides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.
Regulatory Info : RX
Registration Country : USA
ACETAMINOPHEN; BUTALBITAL; CAFFEINE
Brand Name : BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
Dosage Form : TABLET;ORAL
Dosage Strength : 325MG;50MG;40MG
Packaging :
Approval Date : 2003-08-27
Application Number : 40511
Regulatory Info : RX
Registration Country : USA
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
Regulatory Info : RX
Registration Country : USA
ACETAMINOPHEN; BUTALBITAL; CAFFEINE
Brand Name : BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
Dosage Form : TABLET;ORAL
Dosage Strength : 325MG;50MG;40MG
Packaging :
Approval Date : 2008-12-01
Application Number : 40864
Regulatory Info : RX
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : FIORINAL
Dosage Form : CAPSULE;ORAL
Dosage Strength : 325MG;50MG;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Packaging :
Approval Date : 1986-04-16
Application Number : 17534
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE
Brand Name : FIORINAL W/CODEINE
Dosage Form : CAPSULE;ORAL
Dosage Strength : 325MG;50MG;40MG;30MG
Packaging :
Approval Date : 1990-10-26
Application Number : 19429
Regulatory Info : DISCN
Registration Country : USA
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Regulatory Info : RX
Registration Country : USA
ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE
Brand Name : BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE
Dosage Form : CAPSULE;ORAL
Dosage Strength : 325MG;50MG;40MG;30MG
Packaging :
Approval Date : 2001-11-30
Application Number : 75231
Regulatory Info : RX
Registration Country : USA
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Regulatory Info : RX
Registration Country : USA
ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE
Brand Name : BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE
Dosage Form : CAPSULE;ORAL
Dosage Strength : 325MG;50MG;40MG;30MG
Packaging :
Approval Date : 2004-06-10
Application Number : 76560
Regulatory Info : RX
Registration Country : USA
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Regulatory Info : RX
Registration Country : USA
ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE
Brand Name : BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE
Dosage Form : CAPSULE;ORAL
Dosage Strength : 300MG;50MG;40MG;30MG
Packaging :
Approval Date : 2012-07-19
Application Number : 76560
Regulatory Info : RX
Registration Country : USA
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Regulatory Info : RX
Registration Country : USA
Brand Name : BUTALBITAL AND ACETAMINOPHEN
Dosage Form : TABLET;ORAL
Dosage Strength : 300MG;50MG
Packaging :
Approval Date : 2011-08-23
Application Number : 90956
Regulatory Info : RX
Registration Country : USA
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Regulatory Info : DISCN
Registration Country : USA
Brand Name : BUTALBITAL, ASPIRIN AND CAFFEINE
Dosage Form : CAPSULE;ORAL
Dosage Strength : 500MG;50MG;40MG
Packaging :
Approval Date : 2021-10-18
Application Number : 205230
Regulatory Info : DISCN
Registration Country : USA
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Regulatory Info : RX
Registration Country : USA
ACETAMINOPHEN; BUTALBITAL; CAFFEINE
Brand Name : BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
Dosage Form : TABLET;ORAL
Dosage Strength : 325MG;50MG;40MG
Packaging :
Approval Date : 2018-10-31
Application Number : 209587
Regulatory Info : RX
Registration Country : USA
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Regulatory Info : DISCN
Registration Country : USA
ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE
Brand Name : BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE
Dosage Form : CAPSULE;ORAL
Dosage Strength : 325MG;50MG;40MG;30MG
Packaging :
Approval Date : 2015-10-30
Application Number : 203335
Regulatory Info : DISCN
Registration Country : USA
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Regulatory Info : RX
Registration Country : USA
Brand Name : BUTALBITAL AND ACETAMINOPHEN
Dosage Form : CAPSULE;ORAL
Dosage Strength : 300MG;50MG
Packaging :
Approval Date : 2017-12-27
Application Number : 207313
Regulatory Info : RX
Registration Country : USA
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Regulatory Info : RX
Registration Country : USA
ACETAMINOPHEN; BUTALBITAL; CAFFEINE
Brand Name : BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
Dosage Form : CAPSULE;ORAL
Dosage Strength : 300MG;50MG;40MG
Packaging :
Approval Date : 2019-12-17
Application Number : 210817
Regulatory Info : RX
Registration Country : USA
As a CDMO, Mikart offers integrated CDMO services for Solid Dose & Non-sterile Liquid formulations.
Regulatory Info : RX
Registration Country : USA
ACETAMINOPHEN; BUTALBITAL; CAFFEINE
Brand Name : BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
Dosage Form : SOLUTION;ORAL
Dosage Strength : 325MG/15ML;50MG/15ML;40MG/15ML
Packaging :
Approval Date : 2003-01-31
Application Number : 40387
Regulatory Info : RX
Registration Country : USA
As a CDMO, Mikart offers integrated CDMO services for Solid Dose & Non-sterile Liquid formulations.
Regulatory Info : DISCN
Registration Country : USA
ACETAMINOPHEN; BUTALBITAL; CAFFEINE
Brand Name : BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
Dosage Form : TABLET;ORAL
Dosage Strength : 750MG;50MG;40MG
Packaging :
Approval Date : 2003-12-23
Application Number : 40496
Regulatory Info : DISCN
Registration Country : USA
As a CDMO, Mikart offers integrated CDMO services for Solid Dose & Non-sterile Liquid formulations.
Regulatory Info : RX
Registration Country : USA
ACETAMINOPHEN; BUTALBITAL; CAFFEINE
Brand Name : BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
Dosage Form : TABLET;ORAL
Dosage Strength : 325MG;50MG;40MG
Packaging :
Approval Date : 1987-01-21
Application Number : 89175
Regulatory Info : RX
Registration Country : USA
As a CDMO, Mikart offers integrated CDMO services for Solid Dose & Non-sterile Liquid formulations.
Regulatory Info : DISCN
Registration Country : USA
ACETAMINOPHEN; BUTALBITAL; CAFFEINE
Brand Name : ESGIC-PLUS
Dosage Form : TABLET;ORAL
Dosage Strength : 500MG;50MG;40MG
Packaging :
Approval Date : 1988-05-23
Application Number : 89451
Regulatory Info : DISCN
Registration Country : USA
As a CDMO, Mikart offers integrated CDMO services for Solid Dose & Non-sterile Liquid formulations.
Regulatory Info : RX
Registration Country : USA
Brand Name : BUTAPAP
Dosage Form : TABLET;ORAL
Dosage Strength : 325MG;50MG
Packaging :
Approval Date : 1992-10-26
Application Number : 89987
Regulatory Info : RX
Registration Country : USA
As a CDMO, Mikart offers integrated CDMO services for Solid Dose & Non-sterile Liquid formulations.
Regulatory Info : DISCN
Registration Country : USA
Brand Name : BUTAPAP
Dosage Form : TABLET;ORAL
Dosage Strength : 650MG;50MG
Packaging :
Approval Date : 1992-10-26
Application Number : 89988
Regulatory Info : DISCN
Registration Country : USA
As a CDMO, Mikart offers integrated CDMO services for Solid Dose & Non-sterile Liquid formulations.
Regulatory Info : RX
Registration Country : USA
Brand Name : BUTALBITAL AND ACETAMINOPHEN
Dosage Form : TABLET;ORAL
Dosage Strength : 300MG;50MG
Packaging :
Approval Date : 2016-11-15
Application Number : 207386
Regulatory Info : RX
Registration Country : USA
Strides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.
Regulatory Info : RX
Registration Country : USA
ACETAMINOPHEN; BUTALBITAL; CAFFEINE
Brand Name : BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
Dosage Form : TABLET;ORAL
Dosage Strength : 325MG;50MG;40MG
Packaging :
Approval Date : 2020-09-21
Application Number : 203647
Regulatory Info : RX
Registration Country : USA
Strides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.
Regulatory Info : RX
Registration Country : USA
Brand Name : BUTALBITAL, ASPIRIN AND CAFFEINE
Dosage Form : TABLET;ORAL
Dosage Strength : 325MG;50MG;40MG
Packaging :
Approval Date : 2016-09-22
Application Number : 204195
Regulatory Info : RX
Registration Country : USA
Strides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.
Regulatory Info : RX
Registration Country : USA
ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE
Brand Name : BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE
Dosage Form : CAPSULE;ORAL
Dosage Strength : 325MG;50MG;40MG;30MG
Packaging :
Approval Date : 2020-07-08
Application Number : 204649
Regulatory Info : RX
Registration Country : USA
Strides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.
Regulatory Info :
Registration Country : India
Paracetamol; Butalbital; Caffeine
Brand Name :
Dosage Form : Tablet
Dosage Strength : 50MG; 325MG; 40MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Strides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.
Regulatory Info :
Registration Country : India
Paracetamol; Butalbital; Caffeine; Codeine Phosphate
Brand Name :
Dosage Form : Tablet
Dosage Strength : 50MG; 325MG; 40MG; 30MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Strides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Tablet
Dosage Strength : 325MG; 50MG; 40MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
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