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FDA Approval Activities for this Drug…
ACETAMINOPHEN; BUTALBITAL; CAFFEINE CAPSULE; ORAL 325MG;50MG;40MG ACETAMINOPHEN, BUTALBITAL, AND CAFFEINE MIKART | 040085 AB Yes ACETAMINOPHEN; BUTALBITAL; CAFFEINE CAPSULE; ORAL 500MG;50MG;40MG ESGIC-PLUS MIKART | 040261 AB No ACETAMINOPHEN; BUTALBITAL; CAFFEINE CAPSULE; ORAL 500MG;50MG;40MG BUTALBITAL, ACETAMINOPHEN AND CAFFEINE WEST WARD | 040387 Yes ACETAMINOPHEN; BUTALBITAL; CAFFEINE SOLUTION; ORAL 325MG/15ML;50MG/15ML;40MG/15ML ACETAMINOPHEN AND BUTALBITAL AND CAFFEINE MIKART | 040390 AB No ACETAMINOPHEN; BUTALBITAL; CAFFEINE TABLET; ORAL 325MG;50MG;40MG BUTALBITAL, ACETAMINOPHEN AND CAFFEINE ABLE | 040394 AB No ACETAMINOPHEN; BUTALBITAL; CAFFEINE TABLET; ORAL 500MG;50MG;40MG BUTALBITAL, ACETAMINOPHEN AND CAFFEINE ABLE | 089536 AB No ACETAMINOPHEN; BUTALBITAL; CAFFEINE TABLET; ORAL 325MG;50MG;40MG BUTALBITAL, APAP, AND CAFFEINE AXIOM PHARM | 087804 AB No ACETAMINOPHEN; BUTALBITAL; CAFFEINE TABLET; ORAL 325MG;50MG;40MG BUTALBITAL, ACETAMINOPHEN AND CAFFEINE MALLINCKRODT | 089175 AB No ACETAMINOPHEN; BUTALBITAL; CAFFEINE TABLET; ORAL 325MG;50MG;40MG BUTALBITAL, ACETAMINOPHEN AND CAFFEINE MIKART | 089451 AB Yes ACETAMINOPHEN; BUTALBITAL; CAFFEINE TABLET; ORAL 500MG;50MG;40MG ESGIC-PLUS MIKART | 040496 Yes ACETAMINOPHEN; BUTALBITAL; CAFFEINE TABLET; ORAL 750MG;50MG;40MG BUTALBITAL, ACETAMINOPHEN AND CAFFEINE MIKART | 040511 AB No ACETAMINOPHEN; BUTALBITAL; CAFFEINE TABLET; ORAL 325MG;50MG;40MG BUTALBITAL, ACETAMINOPHEN AND CAFFEINE VINTAGE PHARMS | 040513 AB No ACETAMINOPHEN; BUTALBITAL; CAFFEINE TABLET; ORAL 500MG;50MG;40MG BUTALBITAL, ACETAMINOPHEN AND CAFFEINE VINTAGE PHARMS | 040267 AB No ACETAMINOPHEN; BUTALBITAL; CAFFEINE TABLET; ORAL 500MG;50MG;40MG BUTALBITAL, ACETAMINOPHEN AND CAFFEINE WATSON LABS | 088616 AB Yes ACETAMINOPHEN; BUTALBITAL; CAFFEINE TABLET; ORAL 325MG;50MG;40MG FIORICET WATSON PHARMS | 089718 AB No ACETAMINOPHEN; BUTALBITAL; CAFFEINE TABLET; ORAL 325MG;50MG;40MG BUTALBITAL, ACETAMINOPHEN AND CAFFEINE WEST WARD | 040336 AB No ACETAMINOPHEN; BUTALBITAL; CAFFEINE TABLET; ORAL 500MG;50MG;40MG BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE WEST WARD | 076528 AB No ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE CAPSULE; ORAL 325MG;50MG;40MG;30MG BUTALBITAL; ACETAMINOPHEN; CAFFEINE AND CODEINE PHOSPHATE ABLE | 076560 AB No ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE CAPSULE; ORAL 325MG;50MG;40MG;30MG BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE ANABOLIC LABS | 074911 AB No ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE CAPSULE; ORAL 325MG;50MG;40MG;30MG PHRENILIN WITH CAFFEINE AND CODEINE VALEANT | 075929 AB No ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE CAPSULE; ORAL 325MG;50MG;40MG;30MG ACETAMINOPHEN, BUTALBITAL, CAFFEINE, AND CODEINE PHOSPHATE VINTAGE PHARMS | 020232 AB Yes ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE CAPSULE; ORAL 325MG;50MG;40MG;30MG FIORICET W/ CODEINE WATSON PHARMS | 075618 AB No ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE CAPSULE; ORAL 325MG;50MG;40MG;30MG BUTALBITAL; ACETAMINOPHEN; AND CAFFEINE WITH CODEINE PHOSPHATE WEST WARD | 040109 Yes ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE CAPSULE; ORAL 356.4MG;30MG;16MG ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATE MIKART | 040316 Yes ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE TABLET; ORAL 712.8MG;60MG;32MG ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATE MIKART | 086996 AB No ASPIRIN; BUTALBITAL; CAFFEINE CAPSULE; ORAL 325MG;50MG;40MG LANORINAL LANNETT | 017534 AB Yes ASPIRIN; BUTALBITAL; CAFFEINE CAPSULE; ORAL 325MG;50MG;40MG FIORINAL WATSON PHARMS | 087048 AB No ASPIRIN; BUTALBITAL; CAFFEINE TABLET; ORAL 325MG;50MG;40MG BUTALBITAL W/ ASPIRIN & CAFFEINE PHARMERAL | 086710 AB No ASPIRIN; BUTALBITAL; CAFFEINE TABLET; ORAL 325MG;50MG;40MG ASPIRIN AND CAFFEINE W/ BUTALBITAL PUREPAC PHARM | 086398 AB No ASPIRIN; BUTALBITAL; CAFFEINE TABLET; ORAL 325MG;50MG;40MG BUTAL COMPOUND SANDOZ | 017534 AB Yes ASPIRIN; BUTALBITAL; CAFFEINE TABLET; ORAL 325MG;50MG;40MG FIORINAL WATSON PHARMS | 086162 AB No ASPIRIN; BUTALBITAL; CAFFEINE TABLET; ORAL 325MG;50MG;40MG BUTALBITAL, ASPIRIN AND CAFFEINE WEST WARD | 075231 AB No ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE CAPSULE; ORAL 325MG;50MG;40MG;30MG BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE ANABOLIC | 075351 AB No ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE CAPSULE; ORAL 325MG;50MG;40MG;30MG BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE ENDO PHARMS | 074951 AB No ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE CAPSULE; ORAL 325MG;50MG;40MG;30MG BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE STEVENS J | 074359 AB No ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE CAPSULE; ORAL 325MG;50MG;40MG;30MG BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE WATSON LABS | 019429 AB Yes ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE CAPSULE; ORAL 325MG;50MG;40MG;30MG FIORINAL W/CODEINE NO 3 WATSON PHARMS | 011483 Yes ASPIRIN; CAFFEINE; DIHYDROCODEINE BITARTRATE CAPSULE; ORAL 356.4MG;30MG;16MG SYNALGOS-DC LEITNER PHARMS | 013416 AB No ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE TABLET; ORAL 385MG;30MG;25MG NORGESIC 3M | 013416 AB Yes ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE TABLET; ORAL 770MG;60MG;50MG NORGESIC FORTE 3M | 074654 AB No ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE TABLET; ORAL 385MG;30MG;25MG ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE EON | 074654 AB No ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE TABLET; ORAL 770MG;60MG;50MG ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE EON | 075141 AB No ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE TABLET; ORAL 385MG;30MG;25MG ORPHENGESIC PAR PHARM | 075141 AB No ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE TABLET; ORAL 770MG;60MG;50MG ORPHENGESIC FORTE PAR PHARM | 074817 AB No ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE TABLET; ORAL 385MG;30MG;25MG INVAGESIC SANDOZ | 074817 AB No ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE TABLET; ORAL 770MG;60MG;50MG INVAGESIC FORTE SANDOZ | 074988 AB No ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE TABLET; ORAL 385MG;30MG;25MG ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE STEVENS J | 074988 AB No ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE TABLET; ORAL 770MG;60MG;50MG ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE STEVENS J | 010996 AA Yes ASPIRIN; CAFFEINE; PROPOXYPHENE HYDROCHLORIDE CAPSULE; ORAL 389MG;32.4MG;65MG DARVON COMPOUND-65 AAIPHARMA LLC | 089025 AA No ASPIRIN; CAFFEINE; PROPOXYPHENE HYDROCHLORIDE CAPSULE; ORAL 389MG;32.4MG;65MG PROPOXYPHENE COMPOUND 65 TEVA | 020793 Yes CAFFEINE CITRATE SOLUTION; INTRAVENOUS, ORAL EQ 30MG BASE/3ML (EQ 10MG BASE/ML) CAFCIT MEAD JOHNSON | 020793 Yes CAFFEINE CITRATE SOLUTION; ORAL EQ 30MG BASE/3ML (EQ 10MG BASE/ML) CAFCIT MEAD JOHNSON | 009000 Yes CAFFEINE; ERGOTAMINE TARTRATE SUPPOSITORY; RECTAL 100MG;2MG CAFERGOT NOVARTIS | 084294 AB Yes CAFFEINE; ERGOTAMINE TARTRATE TABLET; ORAL 100MG;1MG ERCATAB SANDOZ | 040510 AB No CAFFEINE; ERGOTAMINE TARTRATE TABLET; ORAL 100MG;1MG ERGOTAMINE TARTRATE AND CAFFEINE WEST WARD | Caffeine Citrate Oral Solution, PharmaForce, Tentative Approval | Caffeine Citrate Injection, PharmaForce, Tentative Approval | Butalbital, Acetaminophen & Caffeine Tablets, Mutual Pharma, Approval | Acetaminophen, Caffeine, & Dihydrocodeine Bitartrate Tablets, West-ward Pharma, Approval | Caffeine Citrate Oral Solution, PharmaForce, Approval | Excedrin Migraine (acetaminophen/ aspirin/caffeine) tablets, Novartis Consumer, Labeling Revision | Acetaminophen, Caffeine, and Dihydrocodeine Bitartrate Capsules, Boca Pharmacal, Approval | Acetaminophen, Caffeine, and Dihydrocodeine Bitartrate Tablets, Boca Pharmacal, Approval | Caffeine Citrate Injection, Luitpold Pharma, Approval | Butalbital, Aspirin, & Caffeine Capsules, Mutual Pharma, Approval | Caffeine Citrate Injection, Abraxis Pharma, Approval | Butalbital, Acetaminophen, Caffeine w/Codeine Phosphate Capsules, West-ward Pharma, Supplier Addition | Caffeine Citrate Oral Solution, Abraxis Pharma, Approval | Butalbital, Aspirin and Caffeine Capsules, Mutual Pharma, Labeling Revision | Fioricet w/Codeine Capsules, Watson Labs, Labeling Revision | Fiorinal with Codeine (butalbital, aspirin, caffeine, codeine phosphate) Capsules, Watson Labs, Labeling Revision | Fiorinal with Codeine (butalbital, aspirin, caffeine and codeine phosphate) Capsules, Watson Labs, Labeling Revision | Acetaminophen, Caffeine and Dihydrocodeine Bitartrate Capsules, E5 Pharma, Inc., Manufacturing Revision
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