FDA Orange Book · active-ingredient family
Misoprostol
Misoprostol: 1 brand, 4 generics; first approved Dec 27, 1988; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 4 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
4
Listed patents
0
Presentations
10
Brand (NDA) products
Originator applications
- CYTOTECRLDPFIZERNDA 01926819902 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.2MG TABLET ORAL Rx AB 0.1MG TABLET ORAL Rx AB
Generic (ANDA) products (4)
Abbreviated applications
- MISOPROSTOLMICRO LABSANDA 21687220222 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.1MG TABLET ORAL Discontinued — 0.2MG TABLET ORAL Discontinued — - MISOPROSTOLACQ PHARMAANDA 21020120192 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.1MG TABLET ORAL Rx AB 0.2MG TABLET ORAL Rx AB - MISOPROSTOLNOVEL LABS INCANDA 09166720122 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.1MG TABLET ORAL Discontinued — 0.2MG TABLET ORAL Discontinued — - MISOPROSTOLANI PHARMSANDA 07609520022 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.1MG TABLET ORAL Rx AB 0.2MG TABLET ORAL Rx AB
Listed patents
Orange Book patent file
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Approval history
FDA approval span
First approval
38 yr 4 mo ago
Most recent approval
4 yr ago
Approvals span 1988–2022 across 5 FDA applications.
Brand (NDA) 120%
Generic (ANDA) 480%
Misoprostol: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
