FDA Orange Book · active-ingredient family
Atropine sulfate
Atropine sulfate: 7 brands, 16 generics; first approved Sep 19, 1990; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 16 ANDA applications approved.
Brands (NDA)
7
Generics (ANDA)
16
Listed patents
0
Presentations
32
Brand (NDA) products
Originator applications
- ATROPINE SULFATERLDRSBAUSCH AND LOMB INCNDA 2135812022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1% SOLUTION/DROPS OPHTHALMIC Rx — - ATROPINE SULFATERLDACCORD HLTHCARENDA 21465220202 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.4MG/ML (0.4MG/ML) SOLUTION INTRAVENOUS Discontinued — 1MG/ML (1MG/ML) SOLUTION INTRAVENOUS Rx AP - ATROPINE SULFATERLDRSFRESENIUS KABI USANDA 2092602018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 8MG/20ML (0.4MG/ML) SOLUTION INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL Rx AP - ALCON LABS INCNDA 2081512016
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1% SOLUTION/DROPS OPHTHALMIC Rx AT2 - ATROPINE SULFATERLDRISINGNDA 2062892014
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1% SOLUTION/DROPS OPHTHALMIC Rx AT1 - ATROPINE SULFATERLDRSHOSPIRANDA 02114620013 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG/5ML (0.1MG/ML) SOLUTION INTRAVENOUS Rx AP 0.25MG/5ML (0.05MG/ML) SOLUTION INTRAVENOUS Rx AP 1MG/10ML (0.1MG/ML) SOLUTION INTRAVENOUS Rx AP - ATROPINE SULFATEUS ARMYNDA 0200561990
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.36MG BASE/INH AEROSOL, METERED INHALATION Discontinued —
Generic (ANDA) products (16)
Abbreviated applications
- ATROPINE SULFATEEDENBRIDGE PHARMSANDA 2190132026
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1% SOLUTION/DROPS OPHTHALMIC Rx AT1 - ATROPINE SULFATEHIKMAANDA 21734520252 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.4MG/ML (0.4MG/ML) SOLUTION INTRAVENOUS Rx AP 1MG/ML (1MG/ML) SOLUTION INTRAVENOUS Rx AP - ATROPINE SULFATESOMERSET THERAPS LLCANDA 2150052024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 8MG/20ML (0.4MG/ML) SOLUTION INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL Rx AP - ATROPINE SULFATESOMERSET THERAPS LLCANDA 21596920242 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.4MG/ML (0.4MG/ML) SOLUTION INTRAVENOUS Rx AP 1MG/ML (1MG/ML) SOLUTION INTRAVENOUS Rx AP - ATROPINE SULFATESOMERSET THERAPS LLCANDA 2156182024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1% SOLUTION/DROPS OPHTHALMIC Rx AT1 - ATROPINE SULFATESOMERSETANDA 2177912024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1% SOLUTION/DROPS OPHTHALMIC Rx AT2 - ATROPINE SULFATEMANKIND PHARMAANDA 2181482024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1% SOLUTION/DROPS OPHTHALMIC Rx AT1 - ATROPINE SULFATEMEDEFIL INCANDA 2149702022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/10ML (0.1MG/ML) SOLUTION INTRAVENOUS Rx AP - ATROPINE SULFATERSAMNEALANDA 2147522022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1% SOLUTION/DROPS OPHTHALMIC Rx AT1 - ATROPINE SULFATERSAM REGENTANDA 21612020222 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.4MG/ML (0.4MG/ML) SOLUTION INTRAVENOUS Rx AP 1MG/ML (1MG/ML) SOLUTION INTRAVENOUS Rx AP - ATROPINE SULFATEAMNEALANDA 21534220222 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG/5ML (0.1MG/ML) SOLUTION INTRAVENOUS Rx AP 1MG/10ML (0.1MG/ML) SOLUTION INTRAVENOUS Rx AP - ATROPINE SULFATEHIKMAANDA 2135612021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 8MG/20ML (0.4MG/ML) SOLUTION INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL Rx AP - ATROPINE SULFATEAPOTEXANDA 2156242021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1% SOLUTION/DROPS OPHTHALMIC Rx AT1 - ATROPINE SULFATEACCORD HLTHCAREANDA 21286820213 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.25MG/5ML (0.05MG/ML) SOLUTION INTRAVENOUS Rx AP 0.5MG/5ML (0.1MG/ML) SOLUTION INTRAVENOUS Rx AP 1MG/10ML (0.1MG/ML) SOLUTION INTRAVENOUS Rx AP - ATROPINE SULFATEACCORD HLTHCAREANDA 2134242021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 8MG/20ML (0.4MG/ML) SOLUTION INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL Rx AP - ATROPINE SULFATEINTL MEDICATION SYSANDA 2124612020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/10ML (0.1MG/ML) SOLUTION INTRAVENOUS Rx AP
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
36 yr 5 mo ago
Most recent approval
4 mo ago
Approvals span 1990–2026 across 23 FDA applications.
Brand (NDA) 730%
Generic (ANDA) 1670%
Atropine sulfate: 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.
