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Last Updated: March 28, 2024

Cromolyn sodium - Generic Drug Details


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What are the generic 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, Akorn, Apotex Inc, Sandoz, 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. Seventeen suppliers are listed for this compound.

Summary for cromolyn sodium
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
Pharma Consulting Group (PCG)Phase 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
Perrigo CROMOLYN SODIUM cromolyn sodium SPRAY, METERED;NASAL 075427-001 Dec 12, 2001 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
King Pharms Llc INTAL cromolyn sodium SOLUTION;INHALATION 018596-001 May 28, 1982 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Bausch And Lomb CROMOLYN SODIUM cromolyn sodium SPRAY, METERED;NASAL 075702-001 Jul 3, 2001 OTC No Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Micro Labs CROMOLYN SODIUM cromolyn sodium SOLUTION;INHALATION 213658-001 Apr 29, 2022 AN RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Virtus CROMOLYN SODIUM cromolyn sodium SOLUTION;INHALATION 075437-001 Apr 21, 2000 AN RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Micro Labs Ltd India CROMOLYN SODIUM cromolyn sodium CONCENTRATE;ORAL 202745-001 Apr 4, 2013 AA RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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
Allergan OPTICROM cromolyn sodium SOLUTION/DROPS;OPHTHALMIC 018155-001 Oct 3, 1984 ⤷  Try a Trial ⤷  Try a Trial
Mylan Speciality Lp GASTROCROM cromolyn sodium CONCENTRATE;ORAL 020479-001 Feb 29, 1996 ⤷  Try a Trial ⤷  Try a Trial
King Pharms Llc INTAL cromolyn sodium AEROSOL, METERED;INHALATION 018887-001 Dec 5, 1985 ⤷  Try a Trial ⤷  Try a Trial
Sanofi Aventis Us INTAL cromolyn sodium CAPSULE;INHALATION 016990-001 Approved Prior to Jan 1, 1982 ⤷  Try a Trial ⤷  Try a Trial
Mylan Speciality Lp GASTROCROM cromolyn sodium CONCENTRATE;ORAL 020479-001 Feb 29, 1996 ⤷  Try a Trial ⤷  Try a Trial
King Pharms Llc INTAL cromolyn sodium SOLUTION;INHALATION 018596-001 May 28, 1982 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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