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Last Updated: November 2, 2024

CROMOLYN SODIUM - Generic Drug Details


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What are the generic drug sources for cromolyn sodium and what is the scope of patent protection?

Cromolyn sodium is the generic ingredient in seven branded drugs marketed by King Pharms Llc, Sanofi Aventis Us, Ucb Inc, Ailex Pharms Llc, Genera Pharms, Micro Labs Ltd India, Rising, Mylan Speciality Lp, Bausch And Lomb, Apotex Inc, Sandoz, Sciegen Pharms Inc, King Pharms, Allergan, Actavis Mid Atlantic, Bausch, Eugia Pharma, Hikma, Micro Labs, Roxane, Teva Pharms, Virtus, Watson Labs, Wockhardt Bio Ag, Hh And P, Perrigo, and Blacksmith Brands, and is included in thirty-one NDAs. Additional information is available in the individual branded drug profile pages.

There are ten drug master file entries for cromolyn sodium. Eighteen suppliers are listed for this compound.

Summary for CROMOLYN SODIUM
US Patents:0
Tradenames:7
Applicants:27
NDAs:31
Drug Master File Entries: 10
Finished Product Suppliers / Packagers: 18
Raw Ingredient (Bulk) Api Vendors: 76
Clinical Trials: 23
Patent Applications: 8,076
What excipients (inactive ingredients) are in CROMOLYN SODIUM?CROMOLYN SODIUM excipients list
DailyMed Link:CROMOLYN SODIUM at DailyMed
Recent Clinical Trials for CROMOLYN SODIUM

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Texas Tech University Health Sciences Center, El PasoPhase 3
Adli Karadsheh, MD, MSPhase 3
MedAvantePhase 2

See all CROMOLYN SODIUM clinical trials

Pharmacology for CROMOLYN SODIUM
Drug ClassMast Cell Stabilizer
Physiological EffectDecreased Histamine Release
Medical Subject Heading (MeSH) Categories for CROMOLYN SODIUM

US Patents and Regulatory Information for CROMOLYN SODIUM

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Allergan OPTICROM cromolyn sodium SOLUTION/DROPS;OPHTHALMIC 018155-001 Oct 3, 1984 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Ailex Pharms Llc CROMOLYN SODIUM cromolyn sodium SOLUTION;INHALATION 209453-001 Oct 16, 2017 AN RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Virtus CROMOLYN SODIUM cromolyn sodium SOLUTION;INHALATION 075437-001 Apr 21, 2000 AN RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Bausch And Lomb CROLOM cromolyn sodium SOLUTION/DROPS;OPHTHALMIC 074443-001 Jan 30, 1995 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
King Pharms Llc INTAL cromolyn sodium SOLUTION;INHALATION 018596-001 May 28, 1982 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Hh And P CROMOLYN SODIUM cromolyn sodium SPRAY, METERED;NASAL 077976-001 Sep 7, 2007 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for CROMOLYN SODIUM

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
King Pharms Llc INTAL cromolyn sodium AEROSOL, METERED;INHALATION 018887-001 Dec 5, 1985 ⤷  Sign Up ⤷  Sign Up
Mylan Speciality Lp GASTROCROM cromolyn sodium CONCENTRATE;ORAL 020479-001 Feb 29, 1996 ⤷  Sign Up ⤷  Sign Up
King Pharms Llc INTAL cromolyn sodium SOLUTION;INHALATION 018596-001 May 28, 1982 ⤷  Sign Up ⤷  Sign Up
King Pharms Llc INTAL cromolyn sodium AEROSOL, METERED;INHALATION 018887-001 Dec 5, 1985 ⤷  Sign Up ⤷  Sign Up
Allergan OPTICROM cromolyn sodium SOLUTION/DROPS;OPHTHALMIC 018155-001 Oct 3, 1984 ⤷  Sign Up ⤷  Sign Up
Allergan OPTICROM cromolyn sodium SOLUTION/DROPS;OPHTHALMIC 018155-001 Oct 3, 1984 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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