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INDOMETHACIN

 
 
Content specific to this active ingredient…

Drug Information
Prescribing and patient information from leading authorities

Drug Master Files
Type 2 master files on file at the FDA

Safety Information
For prescription drugs containing this active ingredient

Exclusivity
Patent and market exclusivity data

Federal Register
FR search results for this API

FDA Approved Labelling
Information found in this drug's package inserts

Research Links
Chemical identification and research citations

Title 21 Code of Federal Regulations
FDA regulations for this API

 
 
 
 
 
 
 
 

 


 

FDA Approval Activities for this Drug…

Indomethacin Extended-release Capsules USP, 75 mg, Able Labs ANDA 76-114 2/6/02 4/10/03 | Indomethacin Extended-release Capsules USP, 75 mg Eon Labs Manufacturing ANDA 74-464 INDOMETHACIN Capsule, Extended Release; 75MG INDOMETHACIN Able 074464 INDOMETHACIN Capsule, Extended Release; 75MG INDOCIN SR Eon 072410 INDOMETHACIN Capsule, Extended Release; 75MG INDOMETHACIN INWOOD 018851 INDOMETHACIN Capsule; 25MG INDOMETHACIN CLONMEL 018851 INDOMETHACIN Capsule; 50MG INDOMETHACIN CLONMEL 070673 INDOMETHACIN Capsule; 25MG INDOMETHACIN Geneva 070674 INDOMETHACIN Capsule; 50MG INDOMETHACIN Geneva 070719 INDOMETHACIN Capsule; 25MG INDOMETHACIN Ivax 070756 INDOMETHACIN Capsule; 50MG INDOMETHACIN Ivax 016059 INDOMETHACIN Capsule; 25MG INDOCIN MERCK | 016059 INDOMETHACIN Capsule; 50MG INDOCIN MERCK | 070899 INDOMETHACIN Capsule; 25MG INDOMETHACIN Mutual 070900 INDOMETHACIN Capsule; 50MG INDOMETHACIN Mutual 018858 INDOMETHACIN Capsule; 25MG INDOMETHACIN Mylan | 018858 INDOMETHACIN Capsule; 50MG INDOMETHACIN Mylan | 070624 INDOMETHACIN Capsule; 50MG INDOMETHACIN Mylan | 018829 INDOMETHACIN Capsule; 25MG INDOMETHACIN Par 070651 INDOMETHACIN Capsule; 50MG INDOMETHACIN Par 018829 INDOMETHACIN Capsule; 50MG INDOMETHACIN Par 071148 INDOMETHACIN Capsule; 25MG INDOMETHACIN Pliva | 071149 INDOMETHACIN Capsule; 50MG INDOMETHACIN Pliva | 071342 INDOMETHACIN Capsule; 25MG INDOMETHACIN Teva | 070266 INDOMETHACIN Capsule; 25MG INDO-LEMMON Teva | 070267 INDOMETHACIN Capsule; 50MG INDO-LEMMON Teva | 071343 INDOMETHACIN Capsule; 50MG INDOMETHACIN Teva | 073314 INDOMETHACIN Suppository; Rectal 50MG INDOMETHEGAN G AND W 018332 INDOMETHACIN Suspension; 25MG/5ML INDOCIN MERCK | 071412 INDOMETHACIN Suspension; 25MG/5ML INDOMETHACIN Roxane | 018878 INDOMETHACIN SODIUM Injection 1MG BASE/VIAL INDOCIN I.V. MERCK Indomethacin Capsules USP, Able Labs | Indocin (Indomethacin) Capsules, Merck, Labeling Revision | Indocin (Indomethacin) Suppositories, Merck, Labeling Revision | Indocin (Indomethacin) Oral Suspension, Merck, Labeling Revision | Indocin (indomethacin) Capsules, Merck Research, Labeling Revision | Indocin (indomethacin) Suppositories, Merck Research, Labeling Revision | Indocin (indomethacin) Suspension, Merck Research, Labeling Revision | INDOCIN I.V. (indomethacin sodium trihydrate), Merck & Co., Labeling Revision | INDOCIN (indomethacin) Capsules, Merck & Co., Labeling Revision | INDOCIN (indomethacin) Suppositories, Merck & Co., Labeling Revision | INDOCIN (indomethacin) Oral Suspension, Merck & Co., Labeling Revision | Indomethacin Sodium Injection, Bedford Laboratories, Approval | Indomethacin Extended-Release Capsules, Avanthi, Inc., Approval | Indocin (indomethacin) Oral Suspension, IROKO Pharmaceuticals, LLC, Labeling Revision | Indocin (indomethacin sodium) Injection, Lundbeck Inc., Labeling Revision | Indomethacin Injection, APP Pharmaceuticals, LLC, Approval | Indomethacin Capsules, Zydus Pharmaceuticals, Approval | Indomethacin Extended-Release Capsules, Paddock Laboratories, Inc., Approval | Indomethacin Capsules, Hetero Drugs, Ltd., Approval | Indomethacin, indomethacin, Capsule; Oral, Sun Pharm Inds Inc, Approval | Indocin, indomethacin, Suspension; Oral, Iroko Pharms, Manufacturing Change or Addition

^ FDA's latest approval appears at the bottom of this list. ^

                                                                   

 

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